Links to 973 Entry-Level Biotechnology & Life Science Jobs

Primary Responsibilities include but are not limited to the following: Conducting raw material, in process and final product testing in GMP Analytical labs. Analyzing and interpreting results of technical work and testing. Writing, reviewing and approving test results and reports. Crossover and transfer of methods. Conducting Out of Specification investigations. Generating protocols, summary reports, Standard Operating Procedures (SOPs) and other lab-related documents. etc.,

Analyze quality standards for components, materials or services. Apply measures, sampling methods, testing methodology and other procedures that ensure that quality standards are met. We are seeking an experienced, high caliber Mechanical Development Quality Engineer to assure new or modified products conform to quality standards and establish compliance with the quality system. Responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs. Employees act on their strong desire to make a difference, partner with others and put ideas into action. Employees are engaged by a work culture that is team-oriented, fast paced and progressive. etc.

We have an exciting opportunity for a Production Specialist II within our Abbott Rapid Diagnostics business located at Scarborough, Maine. In this role, you will perform the work required for the assembly of components, devices, and/or the final product depending on the trade assigned. Abbott Rapid Diagnostics (formerly Alere) is part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry-leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions. RESPONSIBILITIES: Performs work required for the assembly of components, devices and/or the final product. Performs routine work in all production areas with limited supervision. etc.

The successful candidate will undertake training in all procedures and work in compliance with Good Manufacturing Practices (GMP) defined under our Quality System Regulations and ISO13485 accreditations. In summary, the successful candidate will; Dilute and test antibody reagents for performance in immunohistochemical staining of tissues, according to approved procedures. Aliquot and package finished goods. Document test procedures, organize data and maintain accurate records of work performed according to GMP, QSR and ISO13485. Complete and review batch production records to provide cGMP documentation. Undertake stock-taking. etc.

Process incoming shipments from suppliers, ensuring accuracy of all product data. Aliquot product into vials and assemble kits for customer orders and global stocking. Work with colleagues across the business to resolve discrepancies quickly. Maintain accurate inventory levels using both manual and automated systems.

The successful candidate will play a hands-on role in the company’s use of a variety of molecular biology, assay development, and protein purification techniques in support of various commercial and academic customer projects to deliver high-quality and on-time customized recombinant antibodies. He or she will partner closely with other team members within the group and be required to make observations, analyze data, and interpret results with supervision. etc.

The Desktop Support Technician will be responsible for providing 1st line IT support to internal Abcam US customers. The ideal candidate will be positive, energetic, and detail oriented while working in a fast-paced environment. Responsibilities: Provides basic support for Windows PCs/laptops, printers, telephones and other IT infrastructure. Installs and configures end user laptops, desktops, and virtual desktop systems. etc.

Abcam is looking for a Research Associate to join our in-house manufacturing team in Eugene. This is a permanent lab-based position which will be responsible for manufacturing, quality testing and assembling our expanding portfolio of products. Etc.

This position will provide extensive technical support for fulfilling contract requirements for immunological assays. The incumbent will assist with the performance of immune assay conducted in the Immunology laboratory. Assist in the development and qualification of new immunological assays including; but not limited to, the following: Blood and mucosal sample processing, Multicolor-Flow Cytometry based assays, cytokines and other soluble biomarkers Multiplexing assays (Luminex, MSD platforms), ELISA, ELISpot, and Neutralization Assays, among others. Responsible for the isolation of serum, plasma and PBMCs from human and animal blood or mucosal samples. etc.

The Technician is responsible for the re-manufacture and repair activities of linear accelerators (linacs) that allow Accuray to provide products that meet customer needs and do so in accordance with regulatory requirements. ESSENTIAL DUTIES AND RESPONSIBILITIES: Performs CNC machining operations in the Linac Repair Center. Performs precision Tungsten Inert Gas (TIG) welding of copper, Kovar, and stainless steel. Investigates field returns to decide what the failure was and what actions need to be taken for repair. Assembles and disassembles linear accelerators in accordance with schedule and in accordance with quality system requirements, procedures, and work instructions. Uses Rf equipment for tuning of linear accelerators. etc.

This is an entry level position for a Biotechnician. Employee will carry out manufacturing practices in a cGMP biotechnical facility. The job involves the manual processing of porcine urinary bladders, which includes all aspects from collection of raw materials to packaging of the final product. Following training, work will be expected to be performed independently to a high degree of standard in biomaterial handling. Principal Responsibilities: Collection of raw materials. Rinse and initial cleaning of raw materials upon receipt. Separation and removal of unwanted tissues. Disinfection. Preparation of storage and cleaning solutions. etc.

The Clinical Laboratory Technologist 1 position will be responsible for processing medically relevant biological samples through extraction or high throughput DNA sequencing assays. This role will work within a team of Laboratorians in a fast-paced, high production setting to process research and clinical diagnostic samples to provide a test result to patients, oncologists and other medical practitioners and researchers. As such, high attention to detail and clinical mindedness are crucial to success in this role. Responsibilities: Assignment to one of two labs performing either DNA extractions from human biological samples, or PCR amplification and high-throughput sequencing assays on DNA libraries. Demonstrate good clinical judgment and integrity. Perform DNA extractions, PCR amplification or high-throughput sequencing assays on DNA libraries. etc.

Adaptive Biotechnologies is currently recruiting a Research Associate/Senior Research Associate to join our TCR Discovery team. The successful candidate will work as a part of a team using cellular assays to screen, characterize and develop T cell receptors as potential therapeutic agents. Responsibilities: Isolate and culture human primary immune cells and cell lines. Transfect mammalian cells, as well as optimize and troubleshoot transfection protocols. Use flow cytometric assays to characterize the specificity and potency of T cell receptors, and assess their potential utility as anti-tumor (or alternative disease) therapies. etc.

The essential job function is to support the development and validation of analytical methods for raw materials, work-in-process, and finished products and to provide testing support for the formulation development and clinical supplies release process. ESSENTIAL DUTIES AND RESPONSIBILITIES: The primary duties and responsibilities of this position include the following. Other duties may be assigned. With supervision and direction the analyst is required to: Provide support for the development and validation of pharmaceutical analytical methods for potency, dissolution, impurities/degradation products, residual solvents…using appropriate laboratory instrumentation e.g. HPLC, UHPLC, LC-MS, Dissolution Apparatus, GC… etc.

We are seeking a Research Associate with experience in protein purification to join our team. This role will support Adimab's novel antibody discovery, maturation, and production platform and closely interface with the Antibody Engineering, Protein Analytics, Molecular Core, and Mammalian Protein Production teams. Responsibilities: Conduct primary purifications of proteins expressed in HEK and CHO cells at various scales (24-well plates to large shake flasks) using automated liquid handlers. Perform secondary purifications of antibodies and antigens using standard chromatography systems at a preparative scale. Formulation of buffers associated with purification methods and resin regeneration. etc.

Responsibilities: Preparing solutions and reagents for performing assays on the bench. Perform Next Generation Sequencing-based genomic assays on different workflows (few listed below): RNAseq, Whole Genome Sequencing, Whole Exome Sequencing. Carry out genomic assays under Biosafety Level II Policies and in regulatory compliance. etc.

Adverum is looking for a Research Associate to join our team in Redwood City. This position reports to a Scientist and is a technical position for a highly motivated Research Associate to support the Assay Development group in an industry setting. The candidate would particularly be involved in cell culture service. The Responsibilities will also include routine lab maintenance, GxP materials receiving and shipping, writing test procedures. Maintaining good documentation is required. etc.

The Calibration Technician is responsible for the following activities: Ability to perform all Calibration Technician I functions. Ability to work independently installing, troubleshooting, and calibrating all types of instruments or control systems in any Akorn environment. Maintain calibration records and enter calibration data using software such as Calibration Manager. Daily review and update the calibration validation data. Fluently use software such as MS Excel, Word, and other maintenance manager software such as AMMS to purchase items and complete validation documentation. Develop SOPs for new or existing equipment as required. Coordinate equipment calibrations for equipment to be calibrated. etc.

Direct oversight of assigned production fill room, equipment preparation or glassware preparation employees. Carries out leadership responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities include training employees; planning, assigning, and directing work; appraising performance; addressing complaints and resolving problems. Must be able to communicate effectively with all levels of employees. Must be able to perform simple math calculations. Must be able to solve problems, handle conflict, and make effective decisions under pressure. ESSENTIAL LEAD TECHNICIAN DUTIES AND RESPONSIBILITIES: Include the following. Other duties may be assigned. Provide oversight of the Key Process Steps; i.e., equipment set up and alignment, defined line speed, hold times, machine prime, etc. In addition: Media fill completed in strict adherence to the Batch Record and Media SOP requirements. etc.

The Environmental Monitoring Technician I will perform all environmental monitoring tests required to monitor the manufacturing controlled areas at Akorn’s Grand Avenue facility. ESSENTIAL FUNCTIONS: Include the following. Other duties may be assigned. Must be able to demonstrate and apply good aseptic technique and cleanroom behavior. Must be able to demonstrate and apply good gowning technique during certification, re-certification, and routine monitoring. Must be able to understand the operation and application of all monitoring devices that are automated or manual operation in the department. Must be able to demonstrate the ability to monitor and document all environmental parameters, such as viable sampling, personnel sampling, temperatures, humidity, and differential pressures under static and dynamic conditions. Fill out cleanroom information sheets. etc.

All Sanitization Associates are responsible for all activities associated with the manufacturing and filling operations, required to produce sterile drug products under aseptic conditions. ESSENTIAL FUNCTIONS: Cleaning and sanitizing aseptic production areas. Set up/preparation/cleaning and autoclaving components (for example, washing disassembled equipment such as from the Waukesha Pumps. Assembly of Vispros and FUS Pumps and associated documentation) parts used in aseptic manufacturing operations. Reading and understanding written instruction as detailed on production batch records. Routine aseptic gowning practices. NOTE: Must have flexibility, discipline and not fall out of established limits. Stocking of consumable items, such as bouffant hats and beard covers. Stocking of sterile and non-sterile gowns. etc.

The Research Department at Alnylam is seeking a highly motivated Associate Scientist to join our RNA QC and annealing group and support RNAi-based research and drug discovery. The successful candidate will help in the quality control and annealing of oligonucleotides and siRNA’s for research studies. Additionally, they will evaluate new formulation approaches for CNS and ocular delivery applications and develop suitable assays such as the Bacterial Endotoxins Test (BET) for improved quality control. Summary of Key Responsibilities: Preparation of siRNA duplexes and QC of siRNA to support research and drug discovery. Analysis and analytical method development of newly chemically modified oligonucleotides (single strands and siRNA duplexes). etc.

The company’s U.S. entity, Amarin Pharma Inc., is seeking a Sales Professional for the TULSA, OK territory. The Sales Professional meets established sales goals in promoting Vascepa to general practitioners, specialists and other healthcare professionals in compliance with internal policy and applicable laws/regulations. The Sales Professional will be supported in this initiative with tools and promotional resources designed to have high local impact. The successful professional will achieve sales goals and demonstrate the ability to target and manage their territory strategically while operating within an assigned budget (and adhering to all compliance and administrative duties). etc.

The company’s U.S. entity, Amarin Pharma Inc., is seeking a Sales Professional for the BOISE, ID territory. The Sales Professional meets established sales goals in promoting Vascepa to general practitioners, specialists and other healthcare professionals in compliance with internal policy and applicable laws/regulations. The Sales Professional will be supported in this initiative with tools and promotional resources designed to have high local impact. The successful professional will achieve sales goals and demonstrate the ability to target and manage their territory strategically while operating within an assigned budget (and adhering to all compliance and administrative duties). etc.

The company’s U.S. entity, Amarin Pharma Inc., is seeking a Sales Professional for the Sarasota, FL territory. The Sales Professional meets established sales goals in promoting Vascepa to general practitioners, specialists and other healthcare professionals in compliance with internal policy and applicable laws/regulations. The Sales Professional will be supported in this initiative with tools and promotional resources designed to have high local impact. The successful professional will achieve sales goals and demonstrate the ability to target and manage their territory strategically while operating within an assigned budget (and adhering to all compliance and administrative duties). etc.

The Quality Assurance (QA) Engineer for Bioinformatics is responsible to create and execute software test plans from the bioinformatics pipeline requirements, specifications and test strategies. The QA Engineer works with the bioinformatics team to define attainable testing goals and relay any issues from testing back to the team. Duties and Responsibilities: Create and execute software test plans for bioinformatics pipeline/software development process. Write test reports and communicate with technical and non-technical people. Identify, isolate, and track bugs throughout testing cycles and perform automated and manual testing and identify existing and potential issues. etc.

Operations Technician I will perform multiple duties related to the production of chemicals using a series if chemical processes in a batch type or continuous process chemical plant. These duties require careful observation and recording of data during all steps of the process. Little or no supervision required. Must have good technical and interpersonal skills to lead, direct, and instruct other employees. Some independent decision making will be required. May also be required to perform other duties in support of the plant activities not covered in another classification, including team participation. Assists in assigning tasks to other technicians, monitors performance of personnel, ensures that personnel follow all departmental and AFC policies and procedures, interacts with other personnel of other disciplines, participates in training fellow employees, conveys and logs status of processes, facilities, and personnel to the Crew Chief. etc.

Research Scientist I (Small Scale Manufacturing) in Albany, New York AMRI provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries. The Research Scientist I (Small Scale Manufacturing) is an integral part of the AMRI team, contributing to our success by being part of a multi-disciplinary team, committed to the safe manufacture of active pharmaceutical ingredients (APIs) for use in human clinical trials. Join our talented workforce, where a commitment to excellence and a customer focused attitude is everything. etc.

In this role, you will: Safely manufacture fine chemicals. Intermediates and API manufacturing. Handle the various unit operations (reactions, filtration, distillation, drying, milling, etc.) that are performed on raw materials and various stages of chemical processing according to written manufacturing procedures and SOP’s. Follow and document per batch sheet instructions to produce product according to all cGMP guidelines. Ability to set-up equipment (vessels, tanks, centrifuges, dryers, etc.) for proper processing, Clean and verify equipment and vessels. Record observations of operating conditions. etc.

In this role, you will: Safely manufacture fine chemicals intermediates and API manufacturing. Handle the various unit operations (reactions, filtration, distillation, drying, milling, etc.) that are performed on raw materials and various stages of chemical processing according to written manufacturing procedures and SOP’s. Follow and document per batch sheet instructions to produce product according to all cGMP guidelines. Ability to set-up equipment (vessels, tanks, centrifuges, dryers, etc.) for proper processing, Clean and verify equipment and vessels. Record observations of operating conditions. etc.

Albany Molecular Research Inc. provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries. Summary: Prepare, collect, and test plant purified water, manufacturing raw materials, product in-process, and finished product, and perform environmental monitoring. With limited supervision, learn and perform critical laboratory techniques and complete original work. Author problem reports and participate in investigations. This description is inclusive of EM and testing duties: actual percentages of time spent on each duty may vary based on business needs. etc.

Assembly of Percutaneous Endoscopic Gastrostomy (PEG) devices or products using like materials/components/assembly procedures. Duties and Responsibilities: This list is not comprehensive but meant to represent the most common or important duties of the position. Other duties are required and/or assigned. Hand assembly and gluing of components. Use of manual and semiautomatic fixtures. Inspection of assembled components. Maintain quality and efficiency standards. Complete paperwork accurately and legibly. Cross-functional training required. etc.

Operates injection molding machines according to specific schedules and procedures. Prepares mold inserts and reviews molded component integrity. Duties and Responsibilities: This list is not comprehensive but meant to represent the most common or important duties of the position. Other duties are required and/or assigned. Remove molded components from the mold once the machine has finished its cycle. Prepare cores and mold for next cycle. When applicable test parts during machine cycle to predetermined specifications. Inspect parts for overall integrity while machine is cycling. Maintain quality and efficiency standards. Use of manual and semiautomatic fixtures. Complete paperwork accurately and legibly. etc.

Assembly of feeding sets and other basic assemblies or products using like materials/components/assembly procedures. Duties and Responsibilities: This list is not comprehensive but meant to represent the most common or important duties of the position. Other duties are required and/or assigned. Visual inspection of devices, labels, and packaging. Use of manual and semiautomatic fixtures. Inspection of assembled components. Maintain quality and efficiency standards. Complete paperwork accurately and legibly. Cross-functional training required. etc.

Triage and resolve incidents, problems, and requests efficiently using our ITSM tool. Configure, install, and troubleshoot software, laptops, desktops, IP phones, mobile devices, printers, and other computer peripherals. Provide timely support onsite, remotely, and over the phone as part of our global IT call center. Perform after-hours work as needed on a rotating schedule. Procure standardized hardware and software from vendors, escalating non-standard requests to leadership. Follow change procedures for employee events (new hires, terminations, transfers, promotions, etc.). Assign roles and permissions to network resources such as SharePoint sites, file shares, and ERP systems. etc.

Primary Responsibilities: Work in a cGMP environment to perform the peptide purification processes through chromatography as well as other various purification techniques. Use analytical skills to prevent and solve possible process complications and problems. Work as part of a team to complete specific projects in a timely manner. Follow approved cGMP manufacturing directions such as production batch records, standard operation procedures and standard test procedures. Help the team to install, test, operate and maintain equipment for manufacturing and in-process testing. etc.

Job performance will involve a variety of activities including: Execution of work instructions for testing raw materials, in-process materials/sub-assemblies, and top-level IVD materials to determine compliance to specifications. Critical analysis of data ensuring compliance with standards and specifications. Generation of data reports. Adherence to safety and quality laboratory standards. Upkeep of personal training and associated records. Maintenance of laboratory material stocks and initiation of re-orders. Execution of method validation and stability testing protocols. Identification of non-conforming material and subsequent report initiation and generation (OOS/OOT investigation). etc.

The purpose of this position is to transfer product and process knowledge from developmental clinical production to GMP product manufacturing in the drug product manufacturing division of Argonaut. Responsibilities: Facilitate transfer of new processes from client lab or concept to drug product manufacturing by collaborating with subject matter experts and operations management. Participate in client discussions via phone, video conference, and/or onsite visits. Create and revise client-specific batch records, raw material specifications, and any documentation related to Drug Product Manufacturing. Review executed batch records and other documentation, as needed. etc.

Main Objective: To assemble, label and package medical devices. Essential Duties and Responsibilities: Performs manual and fixture assisted device assembly and packaging on medical device components, kits, convenience packs and / or any clean room specific device assembly as assigned. Performs placement of components onto the blister trays and die cut restraints. Performs label application onto packaging constructs. Performs supplemental label application, blister loading, pouch and blister sealing and visual seal inspection. Load and orient unit devices into unit packages and / or automated equipment. etc.

Main Objective: To produce superior products following Arthrex Manufacturing Inc. machining processes and procedures. This position is eligible for a sign-on bonus. If you are hired, you will be eligible for a $750.00 sign-on bonus (minus appropriate tax withholdings) paid after you complete your first 90 days and are an employee in good standing. Essential Duties and Responsibilities: Operation of Assembly, Laser Mark, Laser Weld, and EDM equipment in accordance to work instructions. Inspect machined work piece to specifications, based on correct AQL. Verify inspection tools issued to job are available and correct. Receives and verifies work order and verifies that the components are correct. Notifies Supervisor or Lead if equipment is not operating properly. etc.

Ascent seeks Quality Control Chemist in Central Islip, NY to scientifically analyze and test raw materials, in-process and finished product samples using modern quality control techniques; develop, validate and test analytical methods for analytical pharmaceutical ingredients (API) and dosage forms; perform quality control/development activities using Chromatography, Spectroscopy, HPLC, GC, TLC, Dissolution etc.; work with advanced analytical equipment like HPLC, GC, DSC and IR and apply knowledge of broad variety of quality control and analytical techniques; validate and analyze results as per regulatory standards such as USP, BP, EP, ICH and USFDA; develop, implement and maintain QC systems and activities; perform in-process inspection, document results and perform a wide variety of inspections, checks, tests and sampling procedures for the manufacturing process; etc.

The primary purpose of the Research Associate II is to support all cell biology and assay development needs. This position will work primarily in a laboratory setting with Scientist and R&D teams. Essential Job Responsibilities: Culturing of both established cell lines and primary (e.g. human T cells) cell cultures. Generation and quality control assessment of lentivirus to support R&D work. DNA purification to support lentiviral production; additional molecular biology experience (e.g. PCRs, molecular cloning) a plus. etc.

Essential Job Responsibilities: Designs and executes AAV-mediated gene-editing of pluripotent stem cells in a controlled manufacturing environment. Performs data collection, analysis and interpretation for stem cell culture and gene-editing processes. Participates in group meetings and regularly presents at cross-functional team meetings. Prepares and reviews the work of others, including but not limited to, technical slide decks, reports, Standard Operating Procedures (SOPs) and production batch records. May serve as a technical resource for preparation of regulatory filings. Supports Process Development to transfer manufacturing processes. etc.

The primary purpose of Research Associates working (RA II and Senior RA) for our Core Technologies Department is to support the molecular engineering of our gene edited Universal Donor Cells. They will work as a key team member on a fast-paced team to assist with Adeno-Associated Virus production and the development and execution of molecular assays to characterize our proprietary gene edited cells. Essential Job Responsibilities: Performing plasmid DNA isolation and producing Adeno-Associate Virus under controlled conditions following SOPs and with detailed real-time documentation. Routinely performing standard molecular biology techniques including primer design, molecular cloning, gDNA isolation, PCR, and Sanger sequence analysis. etc.

This an entry-level position within our protein group. The ideal candidate will be responsible for maintenance of mammalian cell culture stocks, transfection of cell cultures expressing a variety of protein types including therapeutic proteins, antigens and assay reagents. They will not be satisfied with just doing their part but being part of a collaborative team that aims to continually improve. Responsibilities of the position: Tissue Culture: Maintain various mammalian cell lines using sterile techniques; transiently transfect cell cultures for the generation of recombinant proteins; determine cell counts and cell viability using microscope and automated cell counting devices. Monitor metabolites and macromolecular products and take endpoint measurements that could include western blotting an titer measurement using ForteBio Octet. etc.

The individual should have enriched experience in culturing transformed and primary cells and banking cells. In addition, experience in testing samples using qualified cell-based assays (e.g. virus infection assays and proliferation assays) is desired. Additional responsibilities include adherence to all GMP requirements, a basic understanding of FDA/EMEA regulations, effective interactions/communication with Quality management and support of investigations. The QC Analyst may also support identification and implementation of corrective and preventive actions.

Learn techniques spanning across the entire spectrum of analytical chemistry from wet chemistry to HPLC, NMR, Mass Spectrometry, FTIR, GC and GC-MS. Perform testing using a variety of technologies including HPLC, LC-MS, GC, GC/MS, Microscopy, FTIR and UV. Execute projects in support of client needs including product deformulation and product development, failure analysis and problem solving, impurity identification, extractable and leachable studies, and structural characterization

The Clinical Trial Assistant provides a key support function to the clinical operations team. Under general guidance from Clinical Operations, you will support the Clinical team responsible for management of multiple clinical trials (all phases), and assure compliance with SOPs, FDA regulations, GCP and ICH guidelines. Assist with all phases of clinical study activities (feasibility, start-up, maintenance, and close-out).

Prepares compounded sterile products and performs related activities under the direction of a pharmacist. Responsibilities: Essential Duties: Prepares compounded sterile products using aseptic technique. Assists in the set up of the compounding room, equipment, and supplies for preparation of compounded sterile solutions, using aseptic technique. Performs general cleaning and maintenance duties as directed. Participates in cleanroom product introduction activities. Prepares records and monitors results for pharmaceutical quality assurance testing. etc.

Responsibilities: Essential Duties: Under the direction of the PMO Manager, supports the Project Management Office (PMO) related activities to ensure the success of the PMO and its objectives. Works collaboratively in a team environment (Corporate, Manufacturing, Quality, Operations, Supply Chain, Procurement, Engineering, etc.) in support of PMO activities. Collaborates with Project Leaders to update and manage the project portfolio data and capital spend and forecast data via spreadsheet and the project portfolio management system (PPMS). Supports the creation and maintenance of key project portfolio metrics using Excel, Powerpoint, and other tools to provide visibility to management. etc.

The Analytical Scientist will fulfill a critical role in GMP operations. This individual helps with the execution of feasibility evaluation of analytical methods, method development and validations, writing of validation protocols, reports and other technical quality documents; conducts validation related investigations and contributes to improvements in laboratory operations. Your Tasks: Independently plan and execute validation studies for test methods. Implement and perform analytical method transfer to Quality Control Department. Write validation protocols and final reports, test methods, standard operating procedures, and technical reports. Under minimal supervision, conduct and document investigations related to validation activities. etc.

The Chemist (Chem1) function is to develop the peptide manufacture process, manufacture GMP material and perform related activities at Bachem. Your Tasks: Perform synthesis process including solution phase and solid phase peptide synthesis, peptide resin cleavage, resin cleavage with HF or other chemical cocktails. Perform purification process by chromatography, crystallization and other techniques, and in-process test method. Follow approved GMP manufacture directions such as Master Batch Records, Standard Operation Procedures, Standard Test Procedures and other procedures to manufacture GMP materials, perform in-process test, package the product including other related activities. etc.

The Production Technician I performs an integral role as part of the Production team at Bachem. This role is responsible for contributing to the safe and economic manufacture of active pharmaceutical ingredient (API) products, such as peptide or related bioorganic compounds, as a member of a production team. As a Production Technician I, you will be producing APIs from gram to multiple kg scale. The majority of responsibilities will include routine synthetic organic synthesis, the operation of manufacturing equipment and keeping track of batch documentation according to cGMP regulations. etc.

The R&D Chemist I position will be responsible for synthesis and cleavage of GMP grade peptides under GMP regulations. This work will encompass small/medium scale solid-phase peptide synthesis and TFA cleavage to generate crude peptide products for further purification processing. Perform solid-phase peptide synthesis (SPPS) and cleavage/crude peptide isolation steps with direction from Supervisor

The Production Technician I performs an integral role as part of the Production team at Bachem. This role is responsible for contributing to the safe and economic manufacture of active pharmaceutical ingredient (API) products, such as peptide or related bioorganic compounds, as a member of a production team. As a Production Technician I, you will be producing APIs from gram to multiple kg scale.

Perform synthesis process including solution phase and solid phase peptide synthesis, peptide resin cleavage, resin cleavage with HF or other chemical cocktails. Perform purification process by chromatography, crystallization and other techniques, and in-process test method. Procedures and other procedures to manufacture GMP materials, perform in-process test, package the product including other related activities.

Currently, we are looking for Holter Analysis Technicians to join our Clinical Services Team who are passionate about cardiac rhythms and helping cardiac patients through our innovative remote patient monitoring body sensor technologies. The right individuals will join a dynamic and fast-paced start-up environment. Ideal candidates will have CCT or CRAT certification or specialize in cardiac rhythm recognition and interpretation skills. Experience with cardiology or electrophysiology can be advantageous. This position requires PC proficiency, excellent written and verbal communication skills, and meticulous attention to detail. etc.

Provide electro-mechanical maintenance support to all existing manufacturing equipment and ancillary processes, ensuring continuous operation with minimal downtime. Performs required maintenance, troubleshooting, and repair of production equipment to resolve mechanical and electrical issues. Other aspects of the position include project work as well as routine maintenance support.

Responsible for maintaining Quality and Compliance by ensuring product and manufacturing operations conform to Specification, Standard Operating Procedures and Regulatory Standards (Health Canada & FDA). ESSENTIAL DUTIES AND RESPONSIBILITIES: Provide front line day to day support on product quality issues to ensure GMP, regulatory and procedural compliance to maintain high standards of quality. Support the day shift, with requirement to support plant overtime and planned shutdowns when applicable. Provide technical support on product quality issues. Partner with Quality and Production personnel to ensure mitigating actions are identified and implemented. Support timely follow-up on quality exceptions and their preventative/corrective actions. etc.

The primary responsibilities of this role, Production Specialist III of Cell Culture Technology Center (CCTC), are to: Be responsible for all aspects of clinical manufacturing in the following areas such as Cell Expansion, Cell Culture, Purification, Solution Preparation and Weigh/Dispense and work seamlessly across all areas and will be an SME for NLT one area; Participate in new products introductions (NPIs) into CCTC with support from BD and MSAT; Ensure all activities are performed to schedule; Act as delegate to Senior Production specialist; Collaborate with BD and MSAT to ensure cross functional alignment with platform process, equipment, raw materials and/or automation for NLT one area; etc.

The primary responsibilities of this role, Production Associate, are to: Embrace and demonstrate a safety-first culture at all times; Perform daily operations as directed by site leadership; Be accountable for safe and timely delivery of quality supply based on production schedules while maintaining an efficient operation; Perform duties in a manner that support overall site Key Metrics to include: Safety; Quality, TIP (total individual volume performance), TOP (total overall volume performance), and cost efficiency; Embrace an environment that promotes the building of good working relationships within the site; Participate in the execution of HSE, Quality Management System (QMS) and One PSS programs and elements; participates in associated networks; Contribute in plant operations such as conditioning, packaging, lab operations, warehouse / inventory management / distribution, carryover, etc., as assigned by the site leadership team; etc.

Job Description: Commitment to Safety, by following site safety procedures and utilizing safety equipment as required for daily tasks. Uses batch record instructions, job aids, standard operating procedures, and product specifications to execute production activities. Maintains accurate documentation, records and logs in accordance with FDA (Food and Drug Administration), GMPs (Good Manufacturing Practices) and ISO9000 (International Organization for Standardization). Ability to perform minor troubleshooting and problem solving in areas of set-up of equipment and processes. Ability to perform rework and re-packaging of materials as needed. Ability to work in teams to achieve operational goals while being engaged in the process. Communicating issues and concerns to lead or designee. Performs assembly by following released procedures. etc.

Performs routine set up, operation, minor routine maintenance, preventative maintenance (PM) and troubleshooting of moderately complex/automated manufacturing equipment. Controls and adjusts machine settings. Inspects in-process parts to ensure consistent quality and removes defective product, packaging, and component material. Assists with root-cause analysis activities for process or product exceptions. Checks work using prescribed gauges, jigs and fixtures to measure close tolerances. May monitor quality in accordance with statistical process or other control procedures. Ensures accurate documentation of all relevant quality, safety, and maintenance documents. Identifies, troubleshoots, and resolves basic issues associated with the machine performance and/or product quality. etc.

DUTIES: Maintain International Organization for Standardization (ISO) and regional regulatory requirements. Key elements focus on multiple aspects of quality for product design, manufacturing (assembly and test), inspections and customer complaints throughout the product life cycle. Develop Device History Files and maintain in a manner consistent with regulatory requirements. Generate process/product quality information in the form of CTQ (Critical to Quality) indices, recommendations and solutions to emerging issues, to share with project team/operations/suppliers. Supports the coordinated integration of new products into Manufacturing / Operations. Ensures BD Diagnostic Systems divisional, departmental policies, procedures, practices and facilities are in compliance with all applicable regulatory policies. Understanding and coaching others on Quality Systems and procedures. etc.

Working closely with scientists in our development group, this candidate will take a lead role in optimizing, running and interpreting data from a variety of assays to characterize our lead candidate materials. As part of a cross-functional team, optimize and execute a variety of HPLC/UPLC/LCMS methods to assess the purity and integrity of proteins and nucleic acid molecules (natural and synthetic, short and long, RNA and DNA);

Provide general technical consulting to customers and company staff distinguishing among hardware, reagent and software issues in order to resolve or dispatch the appropriate resource at minimum company expense. Through telephone and electronic (i.e. email) technology provide resolutions on Hardware, Software, Assay and Training related calls from existing customer base.

1st, 2nd or 3rd shift positions. Will require rotating weekends, holidays and to backfill vacation requests for other team members. Provide general technical consulting to customers and company staff distinguishing among hardware, reagent and software issues in order to resolve or dispatch the appropriate resource at minimum company expense. Associate will work in the Miami, Florida campus. Primary Duties and Responsibilities: Fielding Customer Calls to Facilitate 24/7 Support Function. Through telephone and electronic (i.e. email) technology provide resolutions on Hardware, Software, Assay and Training related calls from existing customer base. Measured on ability to work efficiently and resolve customer issues using the most cost effective solution. etc.

The analyst role is responsible to work cross-functionally to support all aspects of data that will be housed in BeiGene’s Data Warehouse. The role will manage data and the related process including but not limited to Real World claims, commercial data and epidemiology data. This role reports to Senior Director, System and Standard.

Laboratory Operations Specialist I is a dynamic position that supports all lab operations within the OMICS and Bioanalytical Lab teams ensuring a safe work environment, by maintaining a clean, organized lab and facilitating training as necessary. The successful Lab Support Specialist prioritizes duties for continuous and measurable improvement in the lab. Laboratory Operations Specialist will work primarily in our labs and support instrument calibration, PM tracking, scheduling, and consumables inventory. etc.

The successful candidate will execute development studies, conduct data analysis, document results. Assist in ligand binding assay method development (MSD, ELISA) and provide technique and application support for immunoassays transferred to downstream users. Perform experiments to improve assay performance and robustness. Contribute to experimental design, data analysis, critical thinking, and problem-solving to improve methods or procedures.

The successful candidate will be responsible for developing and executing standard work procedures on a wide range of molecular biology techniques related to Next Generation Sequencing. Major Responsibilities: Execute on and assist in the development of process instructions that ensure accuracy, throughput, and quality. Operate and monitor laboratory automation and instrumentation. Communicate issues and failures as necessary to the appropriate parties. Apply knowledge and experience in specialized areas, with an understanding of the underlying biochemistry. Use that knowledge and understanding to address problems and situations ordinarily encountered in laboratory manufacturing processes. etc.

The Research Associate, Immuno-oncology will be primarily responsible for the development and execution of essential in vitro and ex vivo assays of systemic and tumor-targeted immune cell agonists to enhance progress of Bicycle’s oncology pipeline. In this role, he or she will be a key player in implementing the in vitro characterization of our immune modulators. ey Responsibilities: The applicant will have a strong scientific background and hands-on laboratory skills in immunology, immuno-oncology and/or translational oncology with experience in immunological assay development and in vitro pharmacology. The successful candidate will work as part of a team and will be responsible for running and interpreting immunological and cell-based assays to characterize Bicycle® immune modulators. etc.

Key Responsibilities: Develop sophisticated and robust next-generation sequencing analysis pipelines under the guidance of a Senior Scientist. Work closely with Process Engineers to design process improvement experiments and analyze the resulting data. Perform analysis of clinical bioinformatics data. Assemble and analyze quality metrics from the clinical laboratory. Collaborate with Senior / Principal Scientists and support new scientific insights. etc.

Bio-Rad is looking for a Technical Associate to work in the R&D Development group. The position requires a limited working knowledge of laboratory experimentation, general chemistry, and clinical chemistry. This position will assist and support the development of clinical chemistry controls. The ideal candidate will also possess abilities in data entry/input, and is comfortable working with blood, serum, urine and/or their various components. Responsibilities: Support product development activities through execution of simple routine laboratory tasks. etc.

This position is responsible for filtering, aliquoting, and storing finished proteins products using aseptic techniques in a GMP Lab, following GMP guidelines. Run lyophilizer and perform fill finish (vialing, stoppering, crimping, and labeling of products). Documents batch records following GMP guidelines. Manufacture and bag ProDots. Buffer manufacture for fill finish. (80%) Documentation: SOPs, and for validation/maintenance/cleaning of equipment and facilities. (20%) Key Responsibilities: Filter, aliquot, and bottling of product using aseptic techniques. Run lyophilizer and perform fill finish (vialing, stoppering, crimping, and labeling of products). Manufacture and bag ProDots. etc.

The Quality Technician role is established to support the Simple Plex Consumables team in the Wallingford facility. Assists Quality Analysts and the QA team in our ISO compliant environment. Provides support for QC / QA activities including hands-on evaluation of microfluidic cartridge products (see https://www.proteinsimple.com/ella.html). Key Responsibilities: Understand and follow appropriate quality protocols: Quality Manual; Record Keeping Guidelines; General understanding of Quality body of knowledge (Inspection plans, sampling, etc.); Safety procedures; Department specific SOP’s. etc.

The responsibilities of this position are to develop bioassays on proteins and antibodies to ensure quality products. Maintain cell lines and isolate primary cells for use in the assays. Key Responsibilities: Develop cell-based and functional ELISA binding bioassays for new protein products and improve existing bioassays. Review literature and discuss the new products and experiments with the supervisor. Implement new bioassays under the direction of the supervisor. Write SOPs for new developed bioassays and perform stability testing on new products. Perform product bioassays following the SOPs and assist at all stages of protein expression and purification. Maintain cell lines and isolate primary cells from human or animal blood or tissues for use in bioassays. Freeze stock of cells for future use. etc.

The successful applicant will work with other members of the consumable production team as well as a multidisciplinary team of engineers and scientists to support routine production activities for reagent formulation/ compounding team. Help maintain and track supplies inventory. Preparation of buffers and other biochemical formulations . Conjugation of protein solutions

We currently have an exciting opportunity for an enthusiastic research associate to join our growing R&D team. This position will play an important role in increasing our already extensive catalog of biochemical colorimetric, fluorescent, and luminescent 96-well and 384-well plate assay kits. In addition, this role will assist our analytical services department in establishing additional techniques to expand our service capabilities. This candidate may also be involved in providing technical support to customers. etc.

We are currently looking for an enthusiastic research associate to join our manufacturing team. This position will entail preparing reagents for our assay kits, QCing, and packaging the finished products. This candidate may also join part time in our R&D team.

The Optimization Experience Associate functions with minimal supervision and guidance within the research and development (R&D) laboratory. The Optimization Experience Associate will conduct various R&D activities on new and existing products involving immunohistochemistry (IHC) procedures including, but not limited to, new product designs and optimizations. The Optimization Experience Associate will assist with troubleshooting of reagents and IHC staining, optimization of client menus and any pre-installation tasks needed to ensure client satisfaction. The Optimization Experience Associate is responsible for collecting and organizing relevant data to be used in the distribution to the applicable teams. etc.

Assists the activities associated with IVD reagent development under Design Controls. Supports documentation of new product development and sustainability of existing products to ensure accurate and complete Design records. Contributes to the overall Quality Systems compliance of the Reagent R&D group. Essential Duties and Responsibilities: 1. Product Development/Design Control: a. Facilitates product development projects. b. Drafts Design Outputs for review by Manager, Product Design. etc.

Supports all aspects of audits / audit conduct. Plans, conducts, and reports audits according to Bioclinica’s standard operating procedures (SOPs) and electronic document management system (EDMS) processes. Tracks and/or trends audit issues and/or CAPAs until closure. Provides root cause guidance to CAPA owners and/or conducts root cause analysis when assigned. Champions timely management of quality event reports, audit findings, and CAPAs. Follows-up and verifies effectiveness checks. Ability to work with all levels of Bioclinica personnel and external personnel in a professional and organized manner. Identifies and implements process improvements, with a focus on the audit program. Supports all audit/inspection types (e.g. internal, external, vendor, regulatory inspections, registrar {ISO, SOC etc.}) etc.

Support business development efforts. Contact clients directly at an early stage of the sales lifecycle to initiate meetings and support the development of the RFP pipeline for the Sales Directors. Responsible for developing relationships with clients to expand portfolio with new and existing clients in partnership with the Sales Directors. Supports and operationalizes the Sales team by: Reviewing each sales territory with the designated Sales Manager to identify new and existing targets where penetration and contact is required, enabling the expansion of eHealth solutions. Supporting each defined territory in the priority defined with the Sales Directors to prepare and initiate call plans, support email targeting campaigns and deliver thought leadership pieces which help drive new meetings and enable RFP inclusion. etc.

This role analyzes, designs, programs, debugs, and modifies software enhancements and/or new products used in local, networked, or Internet-related computer programs. Code is used in applications that variously support Bioclinica’s radiologists, clinical data managers, operations staff, clients and partners. Using current programming language and technologies, writes code, completes programming, and performs testing and debugging of applications.

This is a contract position, terms of net 30. Must provide own gloves and sharps container. Must have access to disposal service. MP will go to client's home or place of work to perform draw. MP will be responsible for scheduling their own appointments based on information provided from Biodesix. You must complete scheduling within 24 hours of assignment.

Laboratory technicians assist with the setup and support of the daily activities of the laboratory. In addition, Laboratory Technicians have the technical training and experience required to perform regulated clinical laboratory test realization (test specimen receipt through test result generation) using standard in-vitro laboratory techniques.

Perform all work in compliance with company policy and within the guidelines of Biofire Diagnostic’s Quality System. Responsible for performing quality control testing on incoming reagents use in Film Array. Responsible for maintaining supply stocks as well as coordinating instrument/equipment repairs as necessary. Responsible for all pipet calibrationsand the Artel system calibration.

BioLegend is looking for a Bottling Process Technician for our Formulation Group. This role will be responsible for processing product formulations, filling, capping, labeling, and completing batch records, and putting away Finished Good Inventory (FGI). This is a highly team oriented group which involves working closely with other core teams within the Bottling Department as well as other departments such as Planning, Receiving, Inventory Control, Custom Solution Team (CST), Packaging and Quality Control groups. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Assist in performing various bottling related tasks to include dispensing antibody solutions and capping and labeling of vials, tubes or bottles. etc.

As a Research Associate, you will report to a Senior Scientist or Manager, where you will be able to conduct extensive analysis on new or existing products and consistently report key findings on product research initiatives. Under general supervision and with on-going review, this position researches, designs, develops and/or supports experiments for product development, process optimization applications, analytical methods, and validation activities ensuring a successful transition into a GMP manufacturing environment. The work requires routinely handling small animals and biological samples from animals and human donors. Prior experience in tissue culture, flow cytometry, immunoassays (eg ELISA, immunefluorescent/immune-histochemical staining, Western Blotting,), molecular biology techniques (eg PCR, cloning, etc.), data analysis, and project management are preferred. etc.

The Manufacturing Associate position will function as an important member of the team that manufactures and provides antibodies and reagents to a diverse set of research areas including Immunology, Neuroscience, Cancer, Stem cells, and Cell Biology. This is a great opportunity for you to enhance your knowledge in the biotechnology industry. Essential tasks for this position include: following Standard Operating Procedures (SOP)s, creating and updating batch records, performing limited buffer preparation, cleaning glassware and restocking lab supplies. Additional responsibilities may also include processing troubleshooting and aliquoting bulk antibodies for finished goods inventory. etc.

Filling, weighing and pouring off Dewars that weigh 85 lbs. Perform and assist with data recording of measurements. Maintain accurate testing and sanitation documentation as needed and required by the standard operating procedures

The software test engineer works aside the software team to assist in producing quality software. This position is responsible for the design, implementation and execution of tests to verify that software and firmware operate correctly and meet design specifications. This individual should work creatively to automate testing where feasible. This individual should have knowledge of one or more programming languages. This engineer is expected to work and communicate well with other members, team leadership as well as company management in order to meet the goals of the project. Principal Job Duties and Responsibilities: Perform all work in compliance with company policy and within the guidelines of the bioMérieux Quality System. If in a leadership role – is responsible for leading and managing the portions of the project to which he/she is assigned as a leader to accomplish the goals of the project. etc.

The Manufacturing Technician position is responsible for the operation of high speed equipment used in the production and packaging of BacT/ALERT bottles and/or preparing and formulating the liquid reagents that fill the finished BacT/ALERT bottle in a cGMP compliant manner. The work hours are Sun-Thurs 11:00PM-7:30AM and occasional OT

The Production Technician I position is responsible for the operation of high speed equipment used in the production and packaging of VITEK 2 cards in a cGMP compliant manner. The position may perform or assist in the setup, operation, inspection, maintenance, troubleshooting and cleaning of equipment used throughout the VITEK 2 Card Manufacturing and Packaging processes. Additionally, this individual will be responsible for completing production batches and corresponding documentation for the associated tasks, AQL inspections, reworks and material reconciliation that goes along with the batch. Contribute to building a positive work environment.

Responsible for identifying new potential client opportunities and lead generation through market research, client inquires and other methods to client development. Actively pursue qualified leads and nurture relationships and opportunities. Organize, coordinate and attend client facing and internal meetings to develop contact relationships and Solution development.

The Field Application Scientist will work closely within a matrix environment including Sales, Integration and Engineering, Support, and Marketing to provide the best-integrated solutions to our customers. Responsibilities include working directly with customers to assist in the design of integrated robotic systems, provide on-site support, and assist in sales demonstrations and proposal submission to customers.

Under direct supervision, the Manufacturing Technician I will be responsible for supporting and performing routine procedures associated with the manufacture of the customer’s product. This individual will work independently once they are trained and experienced with technician tasks. Essential Duties & Responsibilities: Perform environmental monitoring and complete documents associated with the activity. Clean and sterilize glassware and other materials. Perform cleaning of cleanroom suites. etc.

The responsibilities of a Quality Technician are to assist in receiving and inspecting raw materials, intermediates and products used in scientific research. Duties may require document and product reconciliation, inventory management (electronic), and assisting with complaint investigations. Employees must have the ability to work independently and as a part of a team environment.

The successful applicant will work with other members of the consumable production team as well as a multidisciplinary team of engineers and scientists to support routine production activities for reagent formulation/ compounding team. Key Responsibilities: Help maintain and track supplies inventory. Preparation of buffers and other biochemical formulations. Conjugation of protein solutions. Record manufacturing tasks in batch records/traveler. etc.

Chemistry Work: Set up a recrystallization pipeline at BioTherapeutics for abscisic acid (ABA) and punicic acid (PUA), with the intention of recrystallizing additional compounds. Conduct recrystallization optimization analytics. Interface with chemistry department with the ABA and PUA development. Setup chemistry work space and keep detailed records of all activities, record these activities in ASANA, the Google Drive, and in a laboratory notebook. Provide weekly and bi-weekly updates of chemistry progress to the BioTherapeutics team. Working with a food science expert to find ways to emulsify pomegranate seed oil for beverage applications.

The Associate Sales Representative (ASR) is an entry level sales role at Bioventus. The ASR is primarily responsible for consulting with and providing clinical and technical information to healthcare professionals and their staff to achieve the sales objectives. Associate Sales Representatives will operate within company policies and procedures and demonstrate a high degree of compliant and ethical behaviors. Successful candidates should be open to relocation, at least to bordering states. Ideal candidates have strong interpersonal skills and determination to provide the best possible experience to our customers and coworkers. etc.

We are seeking a research associate to join our newly formed Genome Sciences team in Cambridge. Reporting to the Scientist, she or he will play a central role in the development, production, and evaluation of CRISPR gene editing components for use in pluripotent stem cells. The qualified candidate will have solid experience in expression and purification of recombinant proteins from bacterial cell culture and have some proficiency with mammalian cell culture using aseptic technique. He or she will also be curious, innovative, persistent, and be able to work independently in the laboratory with minimal supervision. etc.

The basic purpose is to conduct technical activities on preclinical toxicity studies according to study protocols. Receives daily tasking assignments, under moderate supervision, from higher level technical personnel having responsibility for coordinating the tasks of a group. Accountable to supervisor for performance and management for scientific elements of a project.

The Quality Assurance Specialist supports the QA Lead and the company’s quality program by auditing chemists analytical data, routine work, protocols and reports. Primary Duties and Responsibilities: Auditing chemists’ routine project folders for conformance to company and customer requirements. Write, review and edit Standard Operating Procedures (SOP’s, Forms and Methods) and familiarity with internal SOPs. Alternate contact person for QA questions relating to laboratory operations and client correspondences. Work with area management on the writing, issuance and tracking of deviations and investigations for closure. Perform and assist with GMP audits. etc.

The QC Microbiologist II conducts quantitative and qualitative analysis of pharmaceutical products according to FDA, cGMP and Boston Analytical, Inc. Standard Operating Procedures. Duties will include analysis of pharmaceutical products through compendial methods and client specific test protocols. Primary Duties and Responsibilities: Prepares and analyzes samples to determine microbiological quality through the following analyses: Microbial enumeration methods, absence of specified microorganisms, endotoxin, and water quality analysis (bioburden, TOC, Conductivity). Performs genetic analysis of microbial growth to determine Genus/Species of unknown isolates. Collects Environmental Monitoring Samples onsite and offsite at client manufacturing sites. Documents work in a clear and organized manner. etc.

The Chemist conducts quantitative and qualitative analysis of pharmaceutical products according to FDA, cGMP and Boston Analytical, Inc. Standard Operating Procedures. Duties will include analysis of pharmaceutical products using HPLC, GC, Dissolution, AA, UV-Vis, Wet Chemical Analysis and Method Development.

Follow the laboratory's procedures for specimen handling and processing, test analyses, reporting and maintaining records of test examinations. Maintain records that demonstrate that proficiency testing samples are tested in the same manner as patient specimens.

This position works independently to assist R&D and process engineers, scientists, and/or teams in the development and analysis of products, materials, processes, or equipment. Your Responsibilities Will Include: Participate in the operation and maintenance of process equipment. Develop concepts and accordingly construct prototypes/products from concepts. Explore and propose creative solutions based on solid rationales and contribute to design and process concepts. Organize, coordinate, and execute building and testing of prototypes/products per engineering instructions. etc.

With general supervisory direction, assist in the daily support of products, processes, materials, and equipment in order to achieve production goals (i.e., quality, delivery, cost, productivity, and safety). Maintenance activities for automated PC and PLC controlled manufacturing equipment. Identify and troubleshoot process, material or equipment problems to minimize down time and improve process yields. Identify, design, and implement process equipment changes to improve reliability of the process. Modify existing and develop new tooling and fixtures. Revise existing documents, processes, and/or methods to correct or improve processes/product. Work with vendors/suppliers to procure and install tooling, fixtures, and/or equipment. etc.

Your Responsibilities Will Include: Provides daily support of production, processes, materials and equipment in order to achieve NSM department goals (i.e. safety, quality, delivery, and cost). Works cooperatively with R&D, Process Development, Quality, Production, Regulatory, Equipment Engineering, Supply Chain, and Marketing to ensure project success. Successfully contributes to both new product development teams and product support, typically including the following activities: process capability studies, process development, Six Sigma and Value Improvement projects, report preparation and process/test documentation. Designs and coordinates standard engineering tests and experiments. Designs, procures, and fabricates equipment tooling and fixtures. etc.

The Quality Engineer I will provide Quality/Process Engineering support to the Cardiac Rhythm Management and Neuromodulation and potentially other businesses to ensure delivery of the highest quality product to the customer. They will partner with manufacturing and operations to provide quality engineering support and the highest quality of our products. This position may also provide quality engineering support to additional manufacturing lines as necessary. Your Responsibilities Will Include: Reduces and controls process defects (scrap, nonconforming material, customer complaints) by leading efforts and cross-functional teams focused on identifying the primary root causes and implementing corrective and preventative actions. May be responsible for implementing product stops & documenting release criteria. Develops and implements product quality plans, documents and systems by creating product specifications, quality specifications, quality plans, risk analysis, FMEAs in conjunction with other product development team members. May be responsible for risk analyses and FMEAs. etc.

Your Responsibilities Include: Understands and adheres to safety policies and practices. Responsible for quality and adheres to manufacturing process requirements, the Boston Scientific Corporation Quality Policy and the Strategic Quality Process (SQP). Builds product by following all processes in which certified (in their most current revision), and completes other assigned work, while meeting manufacturing goals a8nd metrics. Gains basic understanding of Lean Manufacturing and related principles. Willing to flex and rotate as necessary and work well with all group members, both within the team and cross-functionally. Under the direction of other maintains accurate records such as Manufacturing Execution System (MES), Shop Floor Paperwork (SFP), training Records System (TRS), Product Data Management (PDM), Systems Application & Products (SAP) and Process Equipment Optimization (PEO). etc.

With general supervisory direction, you will be responsible for performing support functions for manufacturing operations, including troubleshooting equipment and process issues, and performing and documenting machine maintenance procedures. Additionally, it is expected that you will partner with engineering in developing methods and procedures to control or modify manufacturing processes. Your Responsibilities Will Include: Identify and troubleshoot process, material or equipment problems to minimize down time. Execute validation plans and compile data. Collect data and perform basic statistical analysis for process characterization and scrap reduction goals. etc.

Your Responsibilities Include: Understands and adheres to safety policies and practices. Responsible for quality and adheres to manufacturing process requirements, the Boston Scientific Corporation Quality Policy and the Strategic Quality Process (SQP). Builds product by following all processes in which certified (in their most current revision), and completes other assigned work, while meeting manufacturing goals a8nd metrics. Gains basic understanding of Lean Manufacturing and related principles. Willing to flex and rotate as necessary and work well with all group members, both within the team and cross-functionally. Under the direction of other maintains accurate records such as Manufacturing Execution System (MES), Shop Floor Paperwork (SFP), training Records System (TRS), Product Data Management (PDM), Systems Application & Products (SAP) and Process Equipment Optimization (PEO). etc.

Performs laboratory analysis or tasks following established procedures and in full compliance with current governmental regulations, official compendia and any other policy / regulation to generate reliable and timely results, to comply with releases due date, reducing cycle time, and providing internal / external customer satisfaction. Responsibilities: The analysis are: bacterial endotoxin, sterility test, bioburden / microbial limit, growth promotion, particulate matter to parenteral products, microbial identification, pH test , ,osmolality, ,density, protein concentration and other analysis related to the release of the products being manufactured. In addition do microbial analyses of: manufacturing utilities (i.e. water, clean condensate, compress air, nitrogen, ).

We are seeking a Lab Assistant to join our Next Generation Sequencing team. Responsibilities: Check inventory and replenish consumable sequencing supplies. Assist in sample sorting and properly distribute them. Maintain laboratory cleanliness. Document and track daily work flow. Help with logistics as needed. Prepare supplies and assist Associate Scientists. etc.

Reporting to a Senior Scientist, Cellular Immunology, we are seeking an experienced, motivated, and highly skilled Cell Biology Associate Scientist. Under scientific and technical supervision, the candidate will perform various cell-based assays and maintain cell lines to contribute to the discovery and development of novel therapeutics at Cabaletta. The position offers growth into additional areas such as translational research and molecular biology, immunology and cell therapy. The position involves both technical and operational responsibilities. etc.

We are seeking an Associate Scientist to support formulation design and development activities within the Formulation team. This role will be responsible for executing oral solid dosage formulation experiments for drug product process development and analytical testing to primarily support early stages of the CDMO projects. Responsibilities: Assists on formulation and drug product process development projects, with an emphasis on early stages of development. Conducts physicochemical characterization and pre-formulation activities. etc.

The position will be responsible for coordinating projects through the Drug Product manufacturing area working with multiple departments to ensure projects are executed on time. Responsible for the conducting demonstration/notebook batch production and creation of cGMP manufacturing batch records to introduce early phase drug product into the 2600 Drug Product Facility. The ideal candidate will have experience in the formulation, optimization and scale-up of solid dose drug product.

This position exists as a support to the manufacturing department. This position labels and delivers all packaging with the correct lot information and ensure that each production team member has the materials that they need to ensure maximum productivity and uptime. What you will do: Label all inner packaging with correct lot information for each machine in operation on a given shift. Apply labels to outer and intermediate packaging for all products on a given shift. Deliver materials as required to each machine in operation on a given shift. Empty the trash and scrap generated from the production cell over the course of a given shift. Assist the team lead with material movement inside the department, including raw materials, finished goods, and WIP materials. etc.

This position exists as a support to the manufacturing department. This position labels and delivers all packaging with the correct lot information and ensure that each production team member has the materials that they need to ensure maximum productivity and uptime. What you will do: Label all inner packaging with correct lot information for each machine in operation on a given shift. Apply labels to outer and intermediate packaging for all products on a given shift. Deliver materials as required to each machine in operation on a given shift. Empty the trash and scrap generated from the production cell over the course of a given shift. Assist the team lead with material movement inside the department, including raw materials, finished goods, and WIP materials. etc.

The Assembly Technician I will be expected to perform basic functions to complete day-to-day production activity. The position requires a highly motivated, positive individual that can work both independently and in a “team” environment. Assembly Technician I level employees will be expected to perform all job duties in the areas they are assigned under basic supervision. They will stay on task and complete quality work with accurate documentation. He/she will be a valuable and trustworthy asset to their work area through quality work of trained processes. This individual must be dedicated to the success of CSI and its quest to continually improve its operations, as well as perform duties to manufacture CSI products, meeting FDA, OSHA, GMP/MDD and ISO compliance requirements. etc.

(Tuesday through Friday 7:00 AM - 3:30 PM and Saturday 9:00am-5:30pm) Receive and record samples into the laboratory information management system (LIMS) to facilitate sample throughput. Data entry of patient and customer data. Perform patient specimen processing under the direct and constant supervision of a licensed CLS.

Be a "Jack/Jane of all trades" and possess a wealth of cross functional knowledge including operational, clinical, and reimbursement. Contact centers and work with center personnel to ensure orders for patient tests are complete (50 %). Liaise between customers and cross-functional internal teams, ensure the timely and successful delivery of our solutions

Cell culture and cell line development using retro- and lenti-virus, CRISPR and downstream analysis of autophagy and signaling. Perform western blotting, FACS and imaging analysis to analyze autophagy and specific target activity in primary cells and cell lines. Aid in conducting genome-wide CRISPR screens for novel target ID.

Expands the technical capabilities of Process Development group, such as technology development, use of the literature and systems development. Assists in moving projects forward toward GMP Manufacturing for clinical trials, registration, or improvements of existing processes and products. Executes on project work including: Primary recovery from cell paste or inclusion bodies of specific proteins/macromolecules, Downstream processing of macromolecules expressed in mammalian cell lines, insect cells, or microbes, Development and execution of purification and analytical protocols.

The Associate Automation Engineer will provide key support for various manufacturing, quality and research systems. This will include Programmable Logic controllers (PLC), OSI-PI for Data Historian, IGNITION for data reporting & remote alarms, process equipment such as Single-Use (SU) Bioreactors, SU Chromatography Purification & Filtration systems, and Other Equipment Manufacturer (OEM) systems in Manufacturing, QC labs and Research Operations.

The Manufacturing Associate I Downstream is responsible for supporting the overall GMP downstream manufacturing process, through the application of broad knowledge of theories and principles utilized to solve operational, as well as routine tasks in the production of bulk biologics from microbial and cell culture systems for Phase I/II & commercial GMP manufacturing.

We are currently seeking candidates for an Associate Scientist with the key duties and skills listed below: Duties and Responsibilities: Consistent compliance with and promotion of all Cayman values, policies, SOPs, and regulations including, but not limited to: Lab Notebook Policy. Safety and regulatory policies. Confidentiality policies. Timely, accurate data entry (AX, SharePoint, P-drive folders, Excel spreadsheets ). Perform assigned tasks with increasing independence: Operate and maintain HPLC, MS, GC, and optical rotation instrumentation. Perform analytical support services for internal chemists and external clients.

The Filling & Assembly Specialist I functions as a member of our Global Supply Chain team to support the discrete manufacturing of our products. Specifically, the Packaging team is responsible for filling and assembly of final products to ensure finished goods inventory is ready and available for customers. This is a temporary 6-month assignment, with hours from 8 AM – 4 PM, Monday – Friday, 37.5 hours per week. Responsibilities: Precision aliquoting and filling of antibody products utilizing liquid handling techniques with strict adherence to SOPs to ensure product quality. Labeling of vials and preparation of packaging for component assembly, adhering to strict quality control guidelines to ensure labeling and packaging meets compliance requirements and standards. Inspecting and packaging product components with manual and/or automated systems to create final products for order fulfillment. Set-up, change-over and operation of labeling, pumping and packaging equipment. Data entry and updating to enable accurate inventory records.

Support the consulting staff on projects across all therapeutic categories and providing the staff with broad experience in a wide range of indications. Perform the secondary research and data analyses that provide the foundation for our commercial assessment, search, and strategy projects. Drug pipeline and clinical trial analyses, indication or company profiling, deal and trend analyses, and literature searches to support findings from the primary research

FUJIFILM Cellular Dynamics, Inc is recruiting for a laboratory technician to work in our cell manufacturing and research facility in Madison, WI. This role provides an outstanding opportunity for a dedicated and responsible individual to contribute to maintaining and improving the operations in our facility. Ideal candidates can demonstrate a track record of self-motivation, strong organizational skills, and dedication to their work. Essential Job Functions: Provide lab support for scientific personnel and overall operations. Place orders, maintain inventory, and stock laboratory supplies. Work with laboratory staff to maintain and mature organizational structure. Organize and put away daily shipments consistent with inventory management, housekeeping and safety standards. Perform maintenance on equipment as specified, including minor repairs and cleaning.

The Support Technician contributes to the manufacturing team effort by accomplishing related tasks and assignments. Understanding and awareness of current Good Manufacturing Practices. (cGMP) and basic familiarity with FDA and EU Guidelines. Able to follow Standard Operating Procedures (SOP’s).

We seek a highly motivated bench scientist to focus on autoimmune target ID and validation. The successful candidate will have good prior experience in immune biology, with experience in assay development using immune cell types, including primary cell assays. Using this expertise, the successful candidate will gain experience learning how to apply large single cell and other datasets, as well as functional genomics approaches, towards the identification and validation of new targets. RESPONSIBILITIES: Develop and execute in vitro immune cell assays to functionally validate novel targets. Participate in the interrogation of single cell datasets towards the identification of novel autoimmune targets (prior experience with single cell RNA sequencing is not required).

Centrillion is seeking Laboratory Technicians for their research and development teams. These positions are in a fast-paced, start-up environment, interacting with R&D scientists from a variety of backgrounds, with a heavy focus on molecular biology and biochemistry. Lab technicians will divide their time between hands-on laboratory work, data analysis, and lab organization and maintenance. The selected individuals will be working in a support role toward the development of new genomics technologies. The candidate will work with multiple scientists to assist with a broad range of duties including making buffers, following protocols, developing or adapting new protocols for new needs.

The Maintenance Technician II is responsible for assisting the Facilities and Engineering Manager with the maintenance, quality, and upkeep of the manufacturing, testing, and animal holding facilities, and the equipment and utilities at each location, in support of the manufacture of biological products consistent with the corporate objectives and external, international, and federal regulatory requirements. Responsibilities and Key Duties: Perform preventive maintenance on HVAC, electrical, structural and other non-critical equipment. Assist in the execution of PMs on critical equipment. Perform non-scheduled maintenance, on all non-critical equipment, in a timely manner as requested via the MWO system. Review and document all repairs, alarms and PM activities according to applicable Standard Operating Procedures.

Job Summary: The following are responsibilities related to the Technologist - IVB in Wilmington, MA: Perform daily test article/substance administration, observation and recording of physical signs of species for contracted laboratory studies. Prepare cage tags and individual animal number tags; prepare and autoclave cages. Prepare data forms for routine study procedures. Assist with preparation of data forms for specialized study procedures. Record study parameters as required by protocol. Ensure adequate supply of dosage equipment during the course of study. Assist in ensuring adequate supply of additional study specified materials such as blood collection tubes. Assist in preparation of test agents.

We are seeking a Technician 1 Microbiology for our Biologics Testing Solutions site located in Malvern, PA. The responsibilities of this role will be specific to the Sterile Services division of the Microbiology department. The following are the responsibilities of the Technician 1 Microbiology: Performance of direct inoculation and membrane filtration sterility testing. Performance of direct inoculation and membrane filtration bacteriostasis and fungistasis testing. Growth promotion testing of sterility and other microbiological testing media.

Perform basic Electron Microscopy sample preparation with minimal supervision. Participate in the documentation of all activities as required. May also assist with setting up study files, inventories, and sending reports and study materials. We are seeking an Electron Microscopy Technician I for our Safety Assessment site located Durham, NC. The following are responsibilities related to the Electron Microscopy Technician I: Log in samples and set up study files for each protocol. Trim tissue, process/embed both viral and tissue specimens with supervision. Prepare solutions/reagents, cut thick/thin sections on the ultramicrotome, and stain slides/grids. Copy and send reports, prepare delivery slips, and return materials to the client. Understand and conduct all processes in compliance with Good Laboratory Practice (GLP) regulations, corporate Standard Operating Procedures (SOP), and the protocol.

The responsibilities of this role as Technician 1 Mammalian Cell Banking will be specific to the Mammalian Cell Banking division of the Manufacturing Services department. Expand and harvest a mammalian cell line to generate several hundred vials of a Cell Bank. Work within a clean room suite while gowned in clean room attire.

Performs technical laboratory activities in support of client studies or procedures. Performs analysis of data for quality and completeness and determines if results are as expected. Records data in compliance with company and regulatory policies and standards to meet quality and accuracy requirements.

We are seeking Research Technicians for our Safety Assessment site located in Ashland, OH. Charles River Ashland is growing and we're seeking motivated individuals to join our team! Extensive on the job training is provided with no prior experience necessary. If you have an interest working with animals and desire a fast paced work environment with tons of opportunity this may be a career for you.

The Research Technician will collect and record data with minimal supervision in the performance of studies. During a typical day, you can expect to perform clinical observations, sample collection, monitoring of food consumption, animal husbandry, and accurate data collection and reporting, along with the handling and restraint of animals.

Under direct supervision, the Production Technician Level 1 is responsible for the preparation and application of components used to produce Chembio diagnostic products. Responsible for the application of all buffers, test lines, control lines, and other components used in Chembio diagnostic products.

Perform multi-step organic synthesis in solution and/or solid support: Optimize conditions to achieve desired yield; perform and interpret data analysis such as LC/MS and NMR; perform purification steps such as extraction, recrystallization, silica gel column chromatography and LC/MS purification; perform cGMP synthesis of pharmaceutical ingredients; and perform process development and scale-up for kilogram quantities; and clearly record and communicate results and challenges to coworkers/supervisor. Equipments and tolls used included NMR, UV, MS and IR, Reactor (from 50ml to 221 to 10000l), vacuum pump, water aspirator, condenser, rotavap, voltage transformer, chromatography columns, TLC monitor, lyophilizer, separation funnel and addition funnel.

Responsible for managing the labeling control process, including generation of new labeling and changes to existing labeling, and submission of labeling information to regulatory authorities; and for the regulatory review and submission of advertising and promotional materials for all Chiesi USA products.а This position is also responsible for providing input to risk management activities.

Supports Quality Inspection Department by completing visual and functional inspections ofMedical Devices. Under minimal supervision prints labels using ERP System. Packages andlabels medical devices and complete documents per Quality Management Systemsrequirements. Conduct visual and functional inspection of finished product for accuracy and adherence tospecifications.

The Clinical Project Assistant I role is an entry level position to the clinical research industry. This role requires organizational skills with a high attention for detail. The ability to work in a team environment, meet deadlines, and prioritize and balance work from multiple projects is necessary. Excellent verbal and written communication skills are essential. This position will support the Clinical Project Assistants II/Senior Clinical Project Assistants, Clinical Project Managers, Clinical Research Associates and other Study Team Members as a supporting role for ongoing clinical studies. The Clinical Project Assistant I position is an integral member of the clinical project team providing support and troubleshooting on various aspects of project.

The primary purpose of the QC Utility Operator is to provide support to the Quality Control Department which includes EM Analysts, Analytical Chemists, Supervisors, Managers and the Director. This support is provided by ensuring the essential job functions of this position are completed as part of the daily and/or weekly schedule.

This position will manage a wide range of administrative and executive support related tasks and will be able to work independently with little or no supervision. Primary Responsibilities: Assay Development: Design and validate cell-based fluorescence and automated electrophysiology assays to support receptor lead selection. Compound Screening: Execute medium throughout compound screening and follow-up pharmacological evaluation of small molecules on lead chemogenetic receptors. Organization and Communication of Data: Analyze and communicate data in written and oral modalities in both informal and formal settings. Generate and manage meticulous method protocols, data, and analysis reports in a clear and highly organized fashion.

Assemble subassemblies and final assemblies per written specifications i.e., work instructions, customer drawings, etc. Complete manufacturing documentation as outlined in the work order package and defined by the customer. Package final product per written specifications. Identify and report any product quality problems or discrepancies.

ou will apply your knowledge to the analysis of large, diverse data sets coming from our clinical and translational research studies. You will help us to develop our therapies and improve patient lives. Positions are available at junior and senior levels. Expertise in data analysis, signal processing, machine learning, statistics. Sound programming skills using data analyses languages (e.g. MATLAB, Python etc.)

The ideal candidate approaches problems creatively and with eagerness; you have probably designed a Raspberry Pi controlled device to needlessly automate some aspect of your life, just because you thought it would be fun! We’d love you to join our R&D team, to design new hardware, to build automated products and to create the world's highest throughput and highest quality molecular biology automation stack.

Tissue culturing of a variety of patient-derived as well as established cellular models. Transient and stable transfection, clonal cell line generation. Expand our understanding of disease biology, therapeutic MOA, biomarker development, andpatient impact. Deep bioanalytical characterization of cells, using a variety of methods

Our Immunology team is seeking a hands-on scientist at our Cambridge, MA site. This role will play a critical role in supporting the research and development of the Immunology Program. This position will assume a key role in developing and implementing novel immunological assays in support of our proprietary therapeutics through an innovative antibody engineering platform. The position will be developing immunological assays in both cell lines and primary cells for identification and prioritization of therapeutic targets for clinical development. The ideal candidate will have a proven track-record of developing creative and novel immunology-based assays for solving complex biological problems, as well as a broad understanding of therapeutic drug discovery and its applications,

Complete Genomics is looking for a Research Associate with a 6 month assignment with potential extension. The Research Associate will have the opportunity to engage in multidicisplinary projects for sequencing technology development. The position will play a key role in developing DNA/RNA libraries for the next generation sequencing. The successful candidate should have a keen desire to work at the bench.

The Manufacturing Engineer I will be responsible for the selection, development, qualification, and scale-up of production processes and equipment across different manufacturing departments. Process objectives are the high quality, high volume production of patient-tailored implants and associated instruments. Essential Duties and Responsibilities: Develop and maintain strong, internal working relationships across ConforMIS. Understand the objectives, responsibilities, and mission of the Operations department and works towards those goals. Prioritize and plan work activities; adapt for changing conditions. Initiation, execution, and documentation of IQ, OQ, & PQ activities. Optimization of manufacturing processes (5S) for Lean Manufacturing.

The QA Manufacturing Coordinator has primary responsibility for handling all front office operations as outlined below. Responsibilities: Including but not limited to: Track Change Controls and Deviations that affect manufacturing particularly those that affect MMR(s) and batch records. Change control assignee within Master Control all CC throughout all departments. Coordinate the bulk label process including creation, customer approval and maintenance. Liaison between Coating and QC, reporting batches completed through compression. Perform check of all issued batches to Manufacturing. Review issued commercial batches for coating material needs/maintain Coating Batch Log. Review of various Manufacturing systems (e.g. pest control, purified water). etc.

The Packaging Set Up Technician I: Primary responsibilities include set up various packaging equipment including but not limited to tablet fillers, bottle unscramblers and cleaners, cappers, cottoner, desiccant feeder, check weigher, metal detectors, labelers, cartoners, ink jet printers, etc.

The Machine Operator at K-Tube Technologies will be skilled in operating machinery in one or more departments of Weld, Plug, Sink, Straightening, Cutting, Chop Cut, and CG. Knowledgeable in performing set ups in accordance with established procedures. Trained in the proper use of tooling for small, medium or large gauge sizes. Will also be responsible for the maintenance of all tooling used in manufacturing. Instructed in sampling procedure and inspection techniques on measuring the OD, using OD gauge and pin gauge for measuring ID. Must be certified to operate a machine and sign off on production. Performs process checklist and sampling procedure. etc.

The Field Based Service Technician located in Boston provides high quality, efficient and timely repair, preventative maintenance and installation of Cook capital equipment at customers' facilities to ensure that the equipment is performing in accordance with system requirements. Respond with limited notice to requests from within the territory, such as emergency service requests, preventative maintenance requests and/or installation requests

The Manufacturing Process Technician is responsible for the safe manufacture of pharmaceutical intermediates and API’s within one of the Corden Pharma Colorado Manufacturing Centers of Excellence. The Technician performs various unit operations on raw materials and intermediates according to written manufacturing procedures and SOPs.

Serves as the detail facilitator for the movement to and from and daily usage of all materials in the Pharmaceutical manufacturing plants. Coordinates material requests from Line Management for the production batches with the Warehouse and Supply Planner and ensures the timely delivery of these materials to meet the production schedule.

The purpose of this position is to review QA/QC documentation, to assess data compliance/validity with regulatory guidelines in the Quality Control Department and ensure that all the work is performed and documented accurately, timely and in compliance with internal procedures and regulatory agencies. Provide technical support for the release of raw materials, finished products, and stability data.

The position will involve completing final assembly and testing of our high mass MALDI detector systems, followed by installation of these systems at customer sites. Due to the novelty of many of the required tasks, training will be provided by CovalX.Additionally, design projects overseeing new product development will be required.

The Research Assistant I is responsible for the performance of pharmacological tasks associated with both client and internal studies which are under the direction of the assigned study manager (typically a Group Leader, Associate Scientist or Senior Associate Scientist). Handle, manipulate and restrain small animals to conduct procedures, including but not limited to, health checks, weighing, measuring and dosing by multiple routes: PO, IP, IV, SC, IM, ID, IT, blood collection, tissue excision, and implants. Accurately report clinical signs under guidance from supervisor.

We are seeking a Research Associate to join our next generation sequencing (NGS) wet lab. The successful candidate will be responsible for performing quality control experiments and generating NGS data to support the development of novel genetic therapies for a serious diseases. This position requires enthusiasm, attention to detail, and a desire to create new medicines for patients. This position reports directly to the head of the NGS wet lab. General Responsibilities: Perform routine quality control experiments on sequencing libraries (fluorescent quantification, capillary electrophoresis, and qPCR) and prepare samples for sequencing. Load and operate Illumina sequencers. Apply operational knowledge of instruments used in the genomics space (e.g. TapeStation, Bioanalyzer, optical plate reader, robotic liquid handling, and Illumina sequencers). etc.

We are seeking a Research Associate to join an exciting, fast-growing and well-financed company to develop novel gene editing therapies for serious diseases. The successful candidate will join the Technical Operations (Tech Ops) group at CRISPR Therapeutics, focusing on development of analytical methods for ex vivo genetically modified cells to support the development of gene editing programs. The individual will develop quantitative assays measuring gene editing in target and non-target cells, cell-based assays measuring the expression and the biological functions of specific genes. The successful candidate will independently design, perform, and analyze experiments for multiple preclinical and clinical programs, and will work independently to support process development, product characterization, and technical transfer to CMOs and GMP test labs. etc.

We are seeking a Research Associate II/Senior Research Associate to join an exciting, fast-growing, and well-financed company to develop novel gene editing therapies for serious diseases. The successful candidate will join the Technical Operations (Tech Ops) group at CRISPR Therapeutics, focusing on development of analytical methods for ex vivo genetically modified cells to support the development of gene editing programs. The individual will develop quantitative assays measuring gene editing in target and non-target cells, cell-based assays measuring the expression and the biological functions of specific genes. He or she will independently design, perform, and analyze experiments for multiple preclinical and clinical programs, and will work independently to support process development, product characterization, and technical transfer to CMOs and GMP test labs.

Responsible for the accurate and timely sampling, testing, shipping and storage of plasma collected from donors. In compliance with Standard Operating Procedures (SOPs), responsible for collecting plasma samples and moving plasma units to freezer to ensure product quality. Ensures plasma units are properly stored according to SOPs, which could include unsuitable plasma units and samples. Ensures accuracy of unit labeling by verifying the pre-printed label matches the dynamic label. Utilizes sterile technique to draw samples and uses heat sealer to assure the sterility and quality of plasma unit samples per SOPs. May ensure samples and units are packed and shipped in accordance with SOPs and center procedures. Prepares shipping and unit disposal documentation. etc.

Responsible for greeting donors at the plasma collection center and conducting a series of registration procedures to verify donor suitability for the plasma pheresis process. In compliance with Standard Operating Procedures (SOPs), assists qualified donors in completing the screening process. The screening procedures includes but are not limited to: assessing the self-administered health history, answering basic medical questions associated with the donation process, referring donors to medical staff when appropriate and performing health screening procedures such as blood pressure, pulse, weight, temperature. Performs finger stick to obtain sample to obtain donor’s hematocrit and total protein levels. etc.

Responsible for preparing the donor, donor area and equipment for the pheresis process. Job Description: Main Responsibilities: Prepares the autopheresis machine for the pheresis process. Monitors the donor and the pheresis process, responds to specific alarms or signals that may occur during the process. Disconnects the donor when the process is complete. Maintains alertness and awareness to any reaction donor may have during or after the pheresis process and notifies appropriate staff. Uses Personal Digital Assistant (PDA) to record incidents that occur during the pheresis process, such as machine alerts and alarms, volume variances and donor adverse events. etc.

Responsible for the accurate and timely sampling, testing, shipping and storage of plasma collected from donors. Main Responsibilities: In compliance with Standard Operating Procedures (SOPs), responsible for collecting plasma samples and moving plasma units to freezer to ensure product quality. Ensures plasma units are properly stored according to SOPs, which could include unsuitable plasma units and samples. May ensure accuracy of unit labeling by verifying the pre-printed label matches the dynamic label. etc.

The incumbent will be a shop floor employee in the manufacturing organization. The incumbent will provide (be trained in) the technical skill-sets necessary to manufacture high quality biologicals safely in a compliant, efficient, and cost effective manner. Becomes trained on basic processes and equipment and serves as a hands-on resource in Production. Cleaning, preparing, and sterilizing production equipment

In compliance with Standard Operating Procedures (SOPs), responsible for collecting plasma samples and moving plasma units to freezer to ensure product quality. Ensures plasma units are properly stored according to SOPs, which could include unsuitable plasma units and samples. Ensures accuracy of unit labeling by verifying the pre-printed label matches the dynamic label.

In compliance with SOPs, performs all aspects of the pheresis procedure and plasma collection, including donor set-up, donor monitoring and donor disconnect. In compliance with SOPs and Food & Drug Administration (FDA) guidelines, performs venipuncture on donors to begin pheresis process. Evaluates vein performance of the donor to identify possible problems; makes necessary corrections in order to expedite donation time and ensure product quality and donor safety. Ensures donation process is efficient and makes adjustments when necessary to make the process a positive experience for the donor.

Prepares the autopheresis machine for the pheresis process. Monitors the donor and the pheresis process, responds to specific alarms or signals that may occur during the process. Disconnects the donor when the process is complete. Maintains alertness and awareness to any reaction donor may have during or after the pheresis process and notifies appropriate staff.

The Clinical Safety Scientist I is responsible for managing serious adverse events (SAEs) in clinical trials or post-marketing programs, focusing on all aspects of the collection, processing, evaluating and reporting of cases in accordance with CTI’s Global Drug Safety and Pharmacovigilance processes, International Council for Harmonisation (ICH) guidelines, Good Clinical Practices (GCP), applicable regulatory guidelines and study procedures. This individual will track cases from receipt to closure, perform verification of safety data, and will utilize clinical / pharmacovigilance judgment in coding of serious events and synthesizing complex clinical information into accurate and complete narratives.

DUTIES & RESPONSIBILITIES: Inspect all incoming component shipments to ensure that all applicable specifications are met. Inspect product shipments coming from contract manufacturers/repackagers to ensure that all necessary components meet quality standards. Help trouble-shoot packaging concerns and communicate with contract manufacturers/ repackagers and vendors. Verifies and inspects incoming materials and works accordingly with Quality Assurance to handle any possible discrepancies. Participates in other quality audits when required. Complete and maintain documentation of all items inspected and findings/conclusion of findings. Provide oversight on production line; assist Production Technicians with questions/inquiries about products. etc.

This is a full-time, non-exempt position. Responsible for processing Spirulina and Astaxanthin. Includes operating all processing equipment and packaging the finished product. Also responsible for shutdown, sanitation and startup of processing systems. Employees in this position will work a designated shift (day shift, swing shift, or graveyard).

DUTIES AND RESPONSIBILITIES: Install, troubleshoot and repair flow cytometers and Cytek Upgrade products with proficiency in a timely manner. Work professionally and courteously as an individual with Cytek’s customers in continuous support of Cytek’s reputation of service excellence. Identify customer needs and contribute to improvements in Cytek products. Manage the daily schedule to ensure appropriate priority is placed upon urgent customer needs while setting customer expectations for issues of less urgency. Customer Management through telephone technical support, service visit scheduling, product problem information gathering, fault isolation, corrective action, and site visit closure with high quality and efficiency. etc.

This individual will work with other scientists in the group to identify and evaluate antibodies and fluorescent dyes for developing flow cytometry reagents. Conduct immunological conjugation with different antibodies and fluorophores. Perform routine analysis of reagent using chromatographic spectrophotometer, HPLC and flow cytometry technique.

We seek a highly motivated individual to participate in the expression and purification of protein reagents to support all discovery and development programs at CytomX. The successful candidate will work as a Temp up to 12 months in the Protein Sciences department. Conduct QC testing of DNAs that goes into transfection. Support the protein production by small and large scale transient transfection of CHO and 293 cells

Executes upstream manufacturing of clinical and commercial products. Executes pre and post processing activities such as: clean of production equipment, including the operation of automated bioreactor, harvest and media prep skids. This position is accountable for executing the manufacturing processes in Contract Manufacturing Facility and/or Master Cell Banking Facility. ESSENTIAL DUTIES AND RESPONSIBILITIES: Ability to work with bioreactor operation and cell culture including aseptic technique. Execute and monitor critical processes supporting mammalian, microbial, and fill finish production facilities. Solid experience with the following: large-scale centrifuges, washers, autoclaves. etc.

The AD Associate I/II position develops, optimizes, and qualifies analytical methods for biopharmaceutical products. The associate also supports drug development departments, such as Purification Department and Cell Culture Department, by performing analytical testing. Develop analytical test procedures on biopharmaceutical products including: potency testing, SEC-HPLC, RP-HPLC, cIEX, Affinity Chromatography, SDS-PAGE, ELISA, IEF.

PRIMARY RESPONSIBLILITIES: Follows company specific Safety procedures/guidelines and Work Instructions. Support in the build, installations, setups and qualifying Robot, Robot End of Arm Tooling (EOAT), Sorting Station, Conveyors and manufacturing related equipment as assigned. Support in any design improvements and changes to Injection Molding system in manufacturing. Support in develop and maintain documentation, initiate and implement assigned change orders. Complete assigned tasks and provide information that supports qualification, such as design, documentation, implementation and validation execution of new/changed equipment or process. Ability to learn to utilize/interpret precision measurements tools.

The position will work with all phases of the Injection Molding on production floor, (Prefer Nessie and Yushin experience) from start- up of molds, troubleshooting, set up of molds, and assist in monitoring quality. Responsible for setting and adjusting machine controls according to established window parameters while troubleshooting “Quality Issues” during production runs. Help Identified and diagnose technical issues for a quick resolution and immediate response to avoid press down time. Ensure to follow SOP and WI procedure and log in all data require for process on each lot running; as well as following all safety precautions to perform all tasks on a safe environment.

Perform and assist with molecular biology and microbiology experiments to support diagnostic development. Work closely with other Research Scientists and Associates to design and execute experiments. Ensure timely and accurate data outputs. Receive and process clinical specimens from submitting laboratories. Ensure quality control of equipment, reagents, and clinical samples.

As a data scientist, you will work closely with a team of research and production professionals. You will be a key member in preparing, interpreting and analyzing business, genomic and clinical data, providing analysis support to our colleagues and our external partners. Perform data analysis that contributes to the process improvement of Decipher products.

You will be part of an interdisciplinary team of fermentation scientists and engineers, automation engineers, software engineers, analytical chemists, and molecular biologists to rapidly develop microbial strains to produce high value natural product medicines. The Analytical Chemistry group is an integral part of the Demetrix team, providing the rest of the company with high quality data while maintaining and balancing accuracy, precision, and throughput. As part of the Analytical Chemistry group, you will help us with operations, instrument maintenance and troubleshooting, and development of new methods while fostering an atmosphere of continued improvement and innovation. etc.

Receive components and chemicals,verify the acceptable condition of the containers prior to receiving the material, examine contents and compare with records such as manifests, packing slips, or invoices to verify accuracy of incoming shipments. Record the receipt of material into company ERP system

The successful candidate will ensure that complex molecular diagnostic assays and systems are performed under appropriate CLIA compliance and regulatory requirements. The Clinical Laboratory Scientist independently performs clinical lab testing and other scientific examinations, record appropriate test documentations, and evaluates test results.

As a member of the Sensor Research and Development team, the Lab Technician will work closely with Scientists and Engineers to manufacture next-generation sensors and support laboratory activities. Perform a wide variety of research and development laboratory tasks and experiments. Check standard laboratory supply inventory to assure adequate inventory levels and proactively place orders when running low.

You'll roll up your sleeves and tackle challenges as diverse as developing best-in-class apps under regulated regimes like HIPAA and FDA’s QMS, stringent cybersecurity requirements, all-in agile process (not SCRUMbutt), difficult and fluid end-user engagement problems, hacking locked-down IoT APIs, user experience design, back-end scalability, and business decision support.

This position reports to the Satellite Office Supervisor and is essential to support our local customer base. This individual will perform DNA buccal swab and blood collections locally and forward the sample to DDC headquarters in Ohio for testing. This individual will run the day-to-day operations of the office independently.

Dyne is seeking a talented and highly motivated Research Associate/Senior Research Associate to join our drug discovery team. This member will work closely with other researchers to develop biomarker assays using a variety of innovative technologies. The successful candidate will be ambitious, motivated, an energetic self-starter who enjoys working in a fast-paced environment. We offer a competitive salary with benefits and an opportunity for learning and advancement in an exciting innovative environment. Primary Responsibilities Include: Execute research plans for in vitro/in vivo studies. Analyze data and communicate findings to team members and management. etc.

The scientist will be involved in the development of library prep biochemistries and reagents for our new NGS technologies. Ideal candidates will have hands-on lab experience, good organizational skills, display a can-do attitude and be flexible about their activities. Expect to be part of a highly energetic and collaborative team.

As a Laboratory Operator II, you will be responsible for high fidelity execution of detailed protocols. Operators are relied on for the immediacy and reliability with which experiments are run on the ECL, so attention to detail is crucial. The Lab Ops team relentlessly clears the queue of customer experiments and keeps the robots in the labs running at all times, with a focus on exactness and increasing efficiency. The entire ECL facility is run in a systematic way, and the team purview encompasses all protocols that enable this, from maintenance and control of instruments to inventory intake.

The Manufacturing Associate II position reports to Manager Manufacturing at Emergent Manufacturing Operations Baltimore (EMOB). Prior experience in GMP manufacturing and operation of GMP process equipment are prerequisites. Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. Operates manufacturing equipment such as: incubators, single-use bioreactors, depth filtration skids, TFF skids, chromatography skids, single-use mixers and in process testing equipment. Demonstrates, understands and adheres to Emergent policies, GMP standards and safety procedures. Informs Manager on progress of projects, transfer of data, process details, etc.

This is a laboratory testing position with the major responsibilities being daily routine testing and laboratory maintenance tasks. Additional responsibilities involve quality systems support. ESSENTIAL FUNCTIONS: Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. Environmental Monitoring Responsibilities: Perform general laboratory duties including, but not limited to: Clean laboratory areas/glassware. Biosafety Cabinet Monthly Cleaning. Safety equipment upkeep including eyewash stations. Transfer and dispose of biohazard waste and chemicals. etc.

Perform WFI sampling and testing as per current protocol, or validation protocols to support the WFI system. Perform sampling of raw materials. Clean the laboratory glassware using dishwasher or manually washing, if necessary. Perform daily laboratory tasks, such as balance calibration checks, temperature chart monitoring, CSR duties, etc.

Adhere to the procedures and safe practices for movement of product and materials and accurately complete all applicable documentation. This applies to room temperature and cold storage loctions. Execute and document procedural steps in compliance with cGMP standards. Perform 100% visual inspection of product and classify rejected materials utilizing approved categories within required timelines (Qualification)

The Manufacturing Associate II position reports to Manager Manufacturing at Emergent Manufacturing Operations Baltimore (EMOB). Prior experience in GMP manufacturing and operation of GMP process equipment are prerequisites. Operates manufacturing equipment such as: incubators, single-use bioreactors, depth filtration skids, TFF skids, chromatography skids, single-use mixers and in process testing equipment

Adhere to the procedures and safe practices for movement of product and materials and accurately complete all applicable documentation. This applies to room temperature and cold storage loctions. Execute and document procedural steps in compliance with cGMP standards. Perform 100% visual inspection of product and classify rejected materials utilizing approved categories within required timelines (Qualification)

The Validation Engineer authors, reviews, executes validation documents and activities with cross-functional teams including performing commissioning and qualification activities, temperature mapping, sterilization validation and creating traceability matrixes. The position requires entry level experience in validation using the Kaye Validator equipment, and basic knowledge of validation concepts and industry standards. The Validation Engineer will also be responsible for providing tactical support to ongoing validation activities at the Canton site. etc.

The Manufacturing Associate II position reports to Manager Manufacturing at Emergent Manufacturing Operations Baltimore (EMOB). Prior experience in GMP manufacturing and operation of GMP process equipment are prerequisites. Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. Operates manufacturing equipment such as: incubators, single-use bioreactors, depth filtration skids, TFF skids, chromatography skids, single-use mixers and in process testing equipment. etc.

This position is responsible for the inspection and packaging of product. Will perform all aspects of Inspection and Packaging with the ability to assist in day to day operations. Demonstrate competency on assigned qualification blocks: Job specific Standard Operating Procedures. New Inspector Qualification. Execute and document procedural steps in compliance with cGMP standards. Adhere to the procedures and safe practices for movement of product and materials and accurately complete all applicable documentation. This applies to room temperature and cold storage locations. etc.

We are recruiting a highly motivated researcher to join our team. This is a unique opportunity to work at the intersection of genomics and therapeutics and participate in the development of a diverse therapeutic pipeline driven by a transformative core technology. The successful candidate will work well across multiple projects in a fast-paced and dynamic environment. Requirements: Conduct in vivo procedures to evaluate efficacy of AAV gene therapy candidates in rodent models, primarily mice. Perform standard mouse procedures including plasma/serum collection, IV injections, necropsies, and tissue collection in compliance with established protocols. Conduct in life safety assessments: monitor body weight, clinical observations, and survival of mice. etc.

The candidate will be responsible for building pipelines and creating tools to manage large volumes of sequencing data and will assist with generating and assessing meta-data to support internal R&D efforts. The ideal candidate will have experience with analysis of large datasets, knowledge of tools and biological databases, SQL knowledge, strong programming skills and proficiency in parallel and cloud computing.

Scope: Be able to manufacture human blood derived oncology drugs per Standard Operating Procedures in a controlled cleanroom environment. Ensures all manufacturing activities are performed under cGMP guide lines. Communicates production deviations/incidents to the supervisor/Manager as soon as it is discovered. Responsibilities: Ensures all training requirements are completed according to Erytech training guidelines. Perform all manufacturing activities according to cGMP guide lines. Record all manufacturing activities in the batch record and Erycaps machine according to the SOP.ng. etc.

As a Part-time Process Assistant (M-F 7-11PM) you will be helping our lead lab technicians sorting samples, making measurements, calculating amount and dispensing micro fluid while logging electronic record. Previous experience working in a molecular biology lab setting is preferred but not required. If you are interested to work in the Bio/Pharma industry, this will be a good entry position.

The Analyst primarily performs analysis of bulk samples using PLM for asbestos, and analysis of non-culturable surface and air samples for fungi. Analyst prepares and analyzes environmental samples according to scientific methodology in compliance with company Quality Assurance programs and SOP’s, and must be knowledgeable of both job-specific routine and complex analyses. The analyst validates and reviews data for accuracy, and enters laboratory data into the LIMS that ultimately generates required reports to clients. Schedules sample workload according to due dates and sample hold times, and must be knowledgeable of the job-specific laboratory testing equipment, requiring the exercise of discretion and judgment in its operation. etc.

Perform lab-scale downstream processing of vaccine products and process intermediates. Perform assays on vaccine products, process intermediates, and related experimental samples using biochemical/analytical tests. Prepare solutions/reagents. Set-up process equipment for lab-scale experiments

Environmental, Health, Safety, Quality (EHSQ) Compliance. Process/equipment and areas of operating responsibility. Completes building equipment safety inspections. Monitors and coordinates building waste recovery and disposal activities. Inventories and orders designated building supplies.

The Patient Financial Services Associate I (PFSAI) position is responsible for the accurate and timely processing of claims, appeals, denials, and statements for Exact Sciences. A PFSAI demonstrates medical insurance knowledge by resolving billing discrepancies, eligibility, denials, appeals, and aged unpaid claim follow up for commercial, government, and plan coverage for optimal Account Receivable (AR) outcomes.

The QA Operations team provides direct support for all manufacturing activities. This position supports the Quality Systems within the Quality Assurance Unit ensuring compliance with federal regulations for current Good Manufacturing Practice (cGMP) for finished pharmaceuticals. Review of batch records during active manufacturing. Perform routine manufacturing area line clearances

The successful and highly motivated candidate will support the in vivo pharmacology research program and contribute to the multidisciplinary research team by designing and executing in vivo studies to determine pharmacokinetics and pharmacodynamics relationships and efficacy of optimized leads. Position Requirements: ESSENTIAL DUTIES AND RESPONSIBILITIES: Conduct in vivo studies in mouse and/or rat models to assess pharmacological characteristics of preclinical drug candidates. Daily dosing (po, iv, ip) of preclinical drug candidates to mice or rats, followed by blood and tissue collection for pharmacokinetic or pharmacodynamic analyses. Tumor implantation and measurement for long-term efficacy and pharmacodynamic studies. Use of aseptic techniques to grow and scale up tumor cells for implantation in mouse models. etc.

Assist in the planning, design and implementation related to animal studies of pharmacokinetics, pharmacodynamics, and efficacy to evaluate and differentiate lead validation and lead optimization programs under general supervision. Compliance with IACUC protocols and AAALAC regulations in conducting general research duties within assigned area of responsibility

Primary role is to perform all forms assembly activities including equipment setup and tear down where required as well as in-process verifications. In addition, this position includes several cross-functional responsibilities comprising Shipping, Receiving, Job Picking, Warehousing and Plant Cleaning and some Maintenance activities. This position also has responsibilities associated with Servicing returned products (disassembly and reassembly, diagnosis and report writing). RESPONSIBILITIES: The duties & responsibilities of the Assembly Technician include, but are not necessarily limited to the following: Perform bench-type processes to complete mechanical and electrical assemblies and sub-assemblies, using hand tools, and electronic and pneumatic tooling. Assemble Exsurco product and equipment as required. etc.

The Quality Engineer plans and directs activities concerned with development, application, and maintenance of quality processes, materials, and products. Additionally, responsible for investigation manufacturing and customer nonconformance’s, determining root causes and corrective actions, reviewing and approving protocols and final reports and developing product specifications and sampling plans.

Fate is currently seeking a motivated associate to join our Clinical Manufacturing team. The successful candidate will execute CMC studies and produce cell stocks in support of Fate's clinical development programs. The position will be responsible for ordering and maintaining lab equipment and supplies, performing experiments to qualify process improvements for manufacture of Fate's products in clinical development, and performing analysis of data. The position will provide technical support for Fate manufacturing and process development activities. The successful candidate will have excellent organizational and communication skills, a keen attention to detail and thrive in a team environment. etc.

The Associate Manufacturing Engineer works closely with Production, Quality, Materials and Engineering to help define and continually improve all manufacturing processes. This position will assist in resolving existing production issues, reviewing the existing process for improvement opportunities with regard to fixturing or other electrical/mechanical solutions, revising the process to ensure efficiency, and ensuring the process is accurately documented.

A Clinical Assistant is responsible for a wide variety of clinical and clerical duties to support the Stool Donation program. The Clinical Assistant works under the general supervision of the Nursing and Supervising clinical staff is responsible for following Standard Operating Procedures to ensure the safety of stool donations. The Clinical Assistant will work collaboratively with donor operations staff and other departments to ensure strict adherence to standard operating procedures and maintain constant communication with clinical staff.

Develop, optimize and perform assays using molecular biology procedures and technologies including qPCR, quantitative western blots, ELISA. In vitro culture of cancer cell lines and primary cells as well as DNA/RNA isolation from blood/tissue is required. Assist in the management of preclinical and clinical samples internally and with third party providers.

The Scientist I, Bioinformatics develops novel methods for detecting, reporting and analyzing alterations in tumor DNA and RNA, while optimizing existing methods. The incumbent provides scientific and technical contributions for a designated project on an interdisciplinary team. The Scientist I, Bioinformatics is also responsible for supporting novel biomarker and companion diagnostics development by mining and analyzing various types of data generated during the product development and validation process. etc.

Foxx Life Sciences is facing overwhelming demand for our products and is seeking entry-level, full-time, hourly WarehouseAssociates to assist with specific, daily functions within general manufacturing and assembly. There will be future possibilities for promotions as the company grows. All training is provided,and prior experience is not required for consideration.

Responsible for the chemical analysis of raw material, in-process, stability and finished products as required for QC. Effectively communicates work and results both orally and in writing. PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT: Performs accurate routine chemical testing, such as wet analysis, assays, water testing and physical testing in full compliance with company directed SOP’s. Reviews SOP’s for applicability and notifies supervisor for necessary changes when needed. Maintains accurate records of all work performed with respect to a given project. Meets facility audit as well as cGMP or GLP requirements. etc.

This position is responsible for procurement, design and integration of equipment, process systems and corresponding utilities. Leads the project from initial design studies to final validation, and maintains project schedule and budget while communicating results to all stakeholders. PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT: Conducts accurate Engineering Studies to develop design space, used for manufacturing construction, process development, equipment procurement and validation master plan. Develops and manages site projects by employing past experience, research, design and concept sketches, layouts, drawings, vendor interaction, preparation of specifications, discussions with appropriate management and site personnel. etc.

Responsible for setting up, operating and monitoring fill equipment per Standard Operating Procedures and current Good Manufacturing Practices. Must be knowledgeable of and practice good aseptic technique to minimize potential for product contamination. Principal Activities Performed By The Incumbent: Practices aseptic technique at all times while working in aseptic areas. Complies with current SOP’s and cGMPs. Maintains aseptic gowning requirements. etc.

Responsible for visually inspecting filled product off the filling line following Standard Operating Procedures (SOP) and current Good Manufacturing Processes (cGMP). The production inspector will work in the Capping Department and on the off-line inspection area and therefore must be knowledgeable of procedures and equipment in each area. Responsibilities: Principal Activities Performed By The Incumbent: Visually inspects products for various defects. Documents work accurately and timely. Complies with current SOP’s and cGMP’s. Sets-up, adjusts, and operates equipment such as inspection machines, cappers, etc.

Responsible for the electronic compilation and publishing of the company’s submissions to global drug, biological, and device regulatory authorities. Reporting to a Manager in Regulatory Affairs (RA), the position is responsible for the compilation and publishing of submissions to regulatory agencies. The position works with Plant and Corporate RA Specialists to obtain required documents.

Key Accountabilities include: Execution of routine production operations, labeling, quality control, inventory management, continuous improvement, maintenance of clean room equipment, carry out work in a safe manner while notifying management of safety issues and risks, assumes other duties and responsibilities as directed by supervisor.

Responsible for the daily coordination and sterilization of product. Performs Preventative Maintenance tasks on the terminal sterilizers. Responsible for sterilizer cycle review, troubleshooting of sterilizer problems, documentation of problems, and retrieval and delivery of product samples. Coordination with Maintenance personnel for repair of sterilizers.

Your tasks: Maintaining and repairing the physical structure of the building, grounds, injection molding machines and auxiliary equipment. Painting and performing structural repairs to masonry, woodwork, and furnishings of buildings. General cleaning and up keep of buildings, including buffing, dusting, sweeping, mopping, vacuuming, and washing windows. Assist other departments as requested, including moving furniture, unloading, and storing supplies. Perform preventative and corrective maintenance on assigned equipment. Diagnose and repair electrical, hydraulic, and pneumatic control system problems on production machinery, auxiliary equipment and fixtures. Plan, layout and install electrical, hydraulic, and pneumatic systems in support of the fabrication and installation of new equipment and fixtures. etc.

For a contract research organization (Frontage Laboratories, Inc. – Exton, PA): design/develop method transfer, method development, validations, quantitation and structure elucidation; perform high-volume bio-analytical sample analysis; perform data analysis, data quality control (QC) and data interpretation for bio-analytical, PK, PD and ADME studies in regulated environment; utilize and maintain analytical instruments, including Liquid Chromatography Tenderm Mass Spectrometry (LC-MS/MS) and Nuclear Magnetic Resonance (NMR); perform technical work related to the care and use of research animals. etc.

Scientist / Bioanalytical Services Essential Functions Run sensitive, reliable and efficient LC-MS/MS bioanalytical assays for TK/PK assessment. Candidates with experience in ICP-MS and/or ICP-MS/MS for bioanalytical or other applications are preferred. Duties: Perform high-volume sample analysis and/or data analysis, data QC, and data interpretation. Maintain schedule of projects and timelines. Coordinate study activities with Principle Investigator to ensure efficiency and quality. Aid in the preparation of study summaries and/or reports. etc.

Performs biologics method transfer, method development and validation according to FDA guidance, Frontage SOP and industry practices. Performs sample analysis following SOPs and methods, prepare, review the data package and reports. Provide training and technical guidance to the junior scientists. Provide assistance to project management to ensure meeting the requirements of project quality, and timelines. Provide assistance to the PI/RS to ensure the compliance. etc.

The Upstream Process Development group is seeking an Associate Scientist with experience in mammalian or insect cell culture technologies. An Associate Scientist assists in conducting experiments for programs and works with the team to maintain the lab and equipment. The individual monitors on going experiments and can identify unusual occurrences. An Associate Scientist understands and applies knowledge within area of expertise and can take an active role in non-routine process development activities. MAJOR ACTIVITIES AND RESPONSIBILITIES: Conducts routine laboratory experiments using established procedures and protocols. Maintains lab equipment, supplies and work area. Quality of work is complete and technically sound to ensure integrity of research. etc.

Responsibilities: May support technical transfer of client project in and to manufacturing as applicable. Summarizes and report data. Interacts with supervisor and reports results and interpretation of experiments, project deliverables, and process readiness. Supports capital projects by providing technical expertise. Supports new project site-fit assessments as needed. Assists in developing SOPs and engineering documents. Familiar with relevant literature. etc.

Fujifilm Diosynth Biotechnologies, U.S.A., Inc. is seeking Downstream Production Technicians (all levels) to work in our Downstream Manufacturing group. The successful candidate will execute Development and Production processes as well as the accompanying documentation. This position could either be a day shift position (7:00 am – 7:00 pm) or a night shift position (7:00 pm – 7:00 am). The candidate hired will be working on day shift for the first six months for training, and then transition to the night shift. Main areas of responsibilities include: Executing development and production processes as well as process documentation. Understanding processing principles and scientific theory behind operations steps. etc.

Essential Functions: Execute method transfers/qualifications/validations based on regulatory guidelines and industry best practices. Perform assays to evaluate the accuracy, precision, specificity, linearity, robustness, and detection/quantitation limits of analytical methods. Maintain laboratory instrumentation and assist with vendor qualifications. Develop expertise on a subset of analytical methods and participate in method troubleshooting activities. Maintain awareness of project timelines and milestones and openly communicate scheduling challenges. Assist in the preparation of technical documents including protocols and reports. Finalize analytical test methods; route documents for approval within Master Control. Interface with other groups to drive project success, including Analytical Development, Project Management, Quality Control, and Quality Assurance. etc.

Develop and maintain equipment and unit operation standards and procedures utilizing 4M (Man, Materials, Machinery and Methods) approach including: Support new equipment purchasing, URS creation and or revision, equipment qualification and procedure creation and or revision. Creation and or revision of recipe or methods for various platforms. Review and/or Approve equipment qualification limits. Review Calibration Tolerances and Approve Out of Tolerance Investigations. Develop and approve procedures for new equipment being introduced into the plant. Support new product transfer by creation or revision of the Process Consumable List. etc.

Essential Functions: Responsible for providing engineering, operational and troubleshooting support to facilities, utilities and process equipment as needed. Responsible for monitoring complex equipment and maintaining the equipment with a minimum of downtime. Responsible for developing, writing, editing and/or reviewing SOPs, JHAs, HECPs, P&IDs and operations/maintenance procedures for facilities, utilities and process equipment. Responsible for the implementation of process improvements and corrective actions as well as the development of maintenance strategies and equipment life cycle. Responsible to support equipment IQ/OQ/PQ or any other validation startup activity as required. Responsible to support Reliability Centered Maintenance (RCM) activities including condition monitoring and predictive technologies as applicable. etc.

May support technical transfer of client project in and to manufacturing as applicable. Summarizes and report data. Interacts with supervisor and reports results and interpretation of experiments, project deliverables, and process readiness. Supports capital projects by providing technical expertise. Supports new project site-fit assessments as needed

Review of QC analytical testing for GMP in-process, release and stability testing as needed: pH, Osmolality, Conductivity & qPCR, RP-HPLC, SEC, Agarose Gel Electrophoresis, UPLC, CE, IEF, Protein Purity Assays, Peptide Mapping, DNA Sequencing and/or UV/Vis Spectrometry preferred. Review technical transfer, qualification and validation protocols as needed.

Assist with quality control analytical testing of samples provided to the QC laboratory. Assist with executing test qualification and validation of QC test methods. Writes and revises Standard Operating Procedures (SOPs) and other related Good Laboratory Practices (GLP)/Good Manufacturing Practices (GMP) documentation

Prepare documents, reports for managers. Schedule and coordinate meetings, travel arrangement. Data processing, input and verification. Monitor and track expenses

Responsibilities include: Case Analysis -- Efficiently analyzes all data (ABI, NG, Exome, Exon Array, MLPA, qPCR, Genome Array, etc.) and completes all primary analysis related steps according to standard procedures. Performs at a consistent level of analysis by completing a reasonable number of analysis steps with minimal errors. Reliably identifies variants meeting confirmation criteria and sends them for confirmation using appropriate methods, as applicable. Aims to identify novel situations and seek prompt and appropriate advice on how to proceed. Makes sure all relevant aspects of a case are complete and either sends them to review or logs them out, as appropriate. etc.

Responsibilities include: Learns and follows the established standard operating procedures for specimen handling and processing, test analysis, reporting of results to team leads, supervisors and test managers, and record-keeping. Adheres to quality control policies; documents all quality control activities, instrument and procedural calibrations, reagent preparation and testing, and instrument maintenance performed. Identifies problems that may adversely affect test performance, take authorized corrective action, and notifies key individuals. Detects when test performance is not within acceptable levels, and documents all corrective action. etc.

Responsibilities include: Learns and follows the established standard operating procedures for specimen handling and processing, test analysis, reporting of results to team leads, supervisors and test managers, and record-keeping. Adheres to quality control policies; documents all quality control activities, instrument and procedural calibrations, reagent preparation and testing, and instrument maintenance performed. Identifies problems that may adversely affect test performance, take authorized corrective action, and notifies key individuals. Detects when test performance is not within acceptable levels, and documents all corrective action. etc.

Perform daily husbandry of rats and mice under modified barrier conditions and document accordingly. Monitor and document animal facility conditions including temperature and humidity daily. Perform twice daily health monitoring of animals, document and report abnormal conditions to the supervisor. Perform general upkeep and cleaning of facility including daily sweeping and mopping and quarterly cleaning

Gilead Sciences is seeking a Sr. Research Associate I with experience in protein purification process development to support operations at our biologic’s development and manufacturing site in Oceanside California. Specific Responsibilities and skills for Position: The successful candidate will have a working understanding of downstream process development including centrifugation, normal and tangential flow filtration, chromatography operations, and virus clearance. The ability to demonstrate hands on experience in several of these areas is expected. Experience with multiple modalities (monoclonal antibodies, antibody drug conjugates, virus particles) produced in microbial and mammalian expression systems is a plus. The candidate is expected to work effectively within the purification team to help design and execute experiments supporting process definition, optimization, and characterization with an increasing level of independence. etc.

To realize our dream of building a next-generation organism company, we must ensure that quality is maintained during all stages of our projects, through to the successful deployment of our organisms and processes. Therefore, we’re seeking a QA/QC Engineer with chemical laboratory experience to help define product specification and maintain a Quality Management System. Plus, you’ll ensure that Ginkgo, our customers, and our contract manufacturers have the necessary methods and processes in place, so that we maintain compliance across any required regulatory standard and consistently meet the defined product and process specifications. Responsibilities: Develop, validate, and execute analytical methods, focusing primarily on accurate and precise quantitation. Perform QA/QC data collection, data integration, and data archiving, with the use of Ginkgo’s proprietary LIMS (laboratory information management system). etc.

We’re seeking highly motivated Medical Technologists to perform routine testing in our high-complexity CLIA laboratory. With a strong focus on quality, accuracy, and efficiency, you’ll be responsible for accessioning received samples, and completing quality control, calibration, maintenance, and proficiency testing in accordance with current laboratory procedures. As a member of Ginkgo’s Clinical Laboratory Operations Team, our Medical Technologists will have a key role in ensuring the success of this important initiative. Please note: this is a fixed-term contractor role for the night shift in our rotation. Anticipated hours are 8:00pm - 8:00am on a "4 days on / 4 days off" shift schedule (which will require some weekend hours). etc.

Provide front-end support for our high-complexity CLIA laboratory. Establish root causes of application errors, escalating serious concerns to engineering team members and ensuring issue resolution. Actively participate in post mortem discussions. Manage detailed records of configuration changes

Execute fermentation processes across multiple Ginkgo organisms, with a focus on filamentous fungi, bacteria, and yeast as directed by senior engineers. Maintain responsibility for setup and breakdown of fermentation equipment. Aid in the preparation of media and other required reagents. Collect and process samples

Job Duties: Responsible for strategic and operational activities of clinical research studies in blood cancer metabolism to ensure adherence to intended timelines and achievements of study goals, while ensuring quality by FDA, EMEA, ICH and GCP guidelines. Facilitating interdisciplinary activities, participating in the clinical trial working group (CTWG), Site Management Team (SMT), and internal team meetings to meet the goals and established timelines. Providing oversight in clinical research Organization (CRO), Central labs and other external vendors to ensure deliverables are met and methods of communication are developed to facilitate an efficient workflow. Providing oversight of activities related to safety reporting compliance. Provide study tracking support (CTMS tracking, start-up tracking, milestone tracking, close-out tracking) and study updates, as requested. Provide coordination and tracking of clinical supply shipments, equipment, and study-specific laboratory samples. etc.

Job Duties: Providing direct support to submission project teams, internal RA stakeholders and all functional disciplines responsible for developing and delivering components for submissions. Performing hands-on daily submission compilation and publishing activities associated with preparation of various dossier types and safety reports, for both new product marketing applications and/or marketed product maintenance packages. Performing overall quality of the assigned documents and dossiers which must comply with all internal Bayer best practices, meet global regulatory requirements, and facilitate the review and timely approval by appropriate regulatory authorities. Reviewing the eCTD compliance of dossier-relevant R&D documents/reports from technical perspective. Supporting the compilation of global dossiers and to deliver technically compliant submission documents/reports, which contribute to the development of submissions that meet the technical requirements and standards set by relevant health authorities. etc.

Job Duties: Provide technical support in developing, authoring, and executing the Commissioning, Installation and Qualification protocols for the chromatography skids and other supporting equipment that are used in the production of drug. Develop, Implement and Install filter integrity testing methods to available automated Filter Integrity Testers (FITs) available on site to verify the integral of the vent filters that will used in the process for WFI Tanks, Autoclaves, supply clean compressed air and as required. Prepare protocols and reports for Validation Project Plan, Validation Master Plan, IQ, OQ, OQ, Traceability Matrix, Engineering test Plans, and Commissioning test strategies following the site Good Data and Documentation Practices (GDP) during protocol execution for qualifying the system or facility. etc.

Job duties: Review, assess and process Lifecycle Safety data and information, across all service lines received from various sources and distribute reports/data onwards to both internal and external third parties following applicable regulations SOPs and internal guidelines under guidance and support of senior operation team members. Receive, triage, review and process data from various sources on time, within budget and meet quality standards. Perform data entry for tracking and safety database, coding relevant medical terminology, writing, descript narratives, generating queries pertinent to the case, performing quality control, assisting with reconciliation, driving case closure, coordinating translations and ensuring reports are sent to the customer within assigned deadlines. etc.

GRAIL is seeking a Laboratory Technician I/II for the R&D Laboratory Management team, who will be primarily responsible for ensuring the efficient operation of GRAIL Research and Development activities. The ideal candidate is a detail-oriented, dynamic team player with experience in both automated and manual molecular biology workflows combined with strong interest in NGS methodologies. The candidate will be expected to partner with many functions of our organization - Automation, Product Development, LIMS, Supply Chain, Biosample Operations, and Clinical Lab - to ensure the successful completion of R&D projects and general Operational support. etc.

Responsible for performing various routine manufacturing tasks following established procedures and cGMP regulations under guidance of a production supervisor and/or senior management. Follow production and manufacturing procedures. Perform equipment preparation, bulk drug formulation, and aseptic filling duties as needed.

Assist the Grand River Aseptic Manufacturing Facilities & Engineering and Operations departments by specializing in facility and utility optimization and providing subject matter expertise on mechanical systems. Run projects and oversee construction activities. Demonstrate, build, and enforce the best practices for all engineering projects and functions within the facilities.

Support validation of cGMP equipment, facilities and processes. These duties will include, but are not limited to: and validation of laboratory systems, production equipment, manufacturing processes and utilities. ESSENTIAL DUTIES & RESPONSIBILITIES: Assist with maintaining and revising validation procedures. Establish and maintain good practices with regards to processes and/or internal conditions leading to an aseptic environment. Establish and execute programs covering equipment, processes, cleaning, process and computer system validation. Assure that all validation is performed to conform to GRAM’s and cGMP requirements. Provide validation support to internal customers such as Technical Services, Quality Control, Manufacturing and other users of validation services. etc.

he successful candidate will support ongoing high-throughput platform production and optimization in the context of several milestone-driven projects. Plan & perform routine molecular biology techniques such as PCR, DNA subcloning, in vitro transcription, cell transformation, cell culture, protein expression & purification, nucleic acid isolation as well as more advanced methods in support of research projects

Identify and screen donors by reviewing medical records and logs and evaluate the donor as to suitability. Screening includes asking health related questions and referring to medical staff when necessary; taking vital signs (blood pressure, pulse and temperature), performing fingerstick (HCT & Total Protein), and reviewing results using the applicable donor management system Maintain donor confidentiality at all times in all areas.

This position is responsible for performing quality assurance functions in the laboratory, including the review of test records, reviewing records, monitoring employee practices, assessing activities for compliance to procedures, and keeping management informed of any quality concerns related to the laboratory operator.

This position is responsible for processing a potential plasma donor from their initial registration at the Source Plasma Center through various procedures and tests that are part of the screening to determine if the donor is suitable for plasmapheresis.

Provide a positive customer experience by providing health information as per standard operating procedure (SOPs) or as directed by the center Medical staff , explaining fees schedules and bonus programs, instruct donors regarding the importance of plasma donation and explains the uses of the products made from donated plasma.

Provide technical leadership in support of building & utility control systems and network infrastructure. Critical systems include Emerson DeltaV, Siemens BAS, and Rockwell PLCs. Collaborate with building stakeholders and vendors throughout the automation lifecycle: gather system/end user requirements; complete design, implementation, and testing/validation of changes; maintain documentation; maintain and monitor various site automation systems.

As an Operational QA Staff, you will manage/lead/be responsible for working on the shop floor addressing quality issues during production shift operating hours. Additional responsibilities include supporting incident and deviation investigations, participation in internal auditing activities and batch record review.

The Clinical Trial Assistant (CTA) is primarily responsible for the coordination of activities associated with the setup and management of clinical studies under the direction of, or as delegated by a member of the Clinical Trial team. Responsibilities will range from clinical study coordination to data entry projects and general office work.

Help with triaging and setting up hardware (Laptops, printers, Lab systems) and supporting software including Office365, Okta and other platforms we use. We’ll need you to be the lead person to work with third party service providers to ensure end to end support is maintained for our office and remote stall working from home.

We are seeking a highly motivated individual who enjoys detail-oriented technical work, can manage diverse responsibilities in the lab, and thrives in a fast-paced work environment. As an integral member of our functional group, this individual will work closely with other team members within Protein Science and partner with other functional areas including Biology, New Technologies, and Translational Medicine. The ideal candidate will have strong technical aptitude for lab work and a problem-solving mindset that is diligent and flexible. Our Research organization is comprised of a small but diverse group of scientists with a wide range of experience and backgrounds. etc.

Maintain and/or accelerate timelines for achieving clinical operational milestones. Serve as the primary liaison with research sites; monitor the day-to-day conduct of the study, and resolve problems associated with the study; provide administrative and logistical support as needed. Ensure that documentation from investigators and investigational sites meets FDA/GCP/ICH requirements

We are searching for a highly motivated and team-oriented Clinical Laboratory Technician (CLT) to support a wide variety of molecular biology, biochemical, and extraction techniques to support projects focused on viral infection. Perform specimen processing and accessioning. Perform Automated RNA extraction. Perform PCR-based genetic testing in accordance with standard operating procedures.

Prior experience not required, however, candidates with familiarity with any industrial assembly and/or machine shop equipment such as saws, drills, electronics soldering, and working with small/miniature machined components, will be given preference. Capable of reading and understanding technical specifications of a mechanical capacity.

The Engineering Technician will work to maintain, troubleshoot and repair medical diagnostic instruments, commission new equipment, through quality service and professionalism. We are seeking hard working, motivated, and well-organized individuals with a focus on continuous product improvement to exceed expectations.

The General Fabricator: Operates painting and other operations in the fabrication department. Promotes Helmer values as demonstrated in personal productivity and quality of work, management of internal/external relationships, actively seeking out and participating in Continuous Improvement practices, and willingness to engage and support team initiatives. Comply with workplace safety procedures. Regular and reliable attendance, which includes punctuality and working scheduled overtime, is necessary to meet our commitment to provide quality products and service to our customer. etc.

The Assembler I: Performs repetitive assembly tasks using basic hand tools to build temperature controlled storage units, refrigerators/freezers and thawing systems or under counter temperature controlled storage units. May clean and pack units. Promotes Helmer values as demonstrated in personal productivity and quality of work, management of internal/external relationships, actively seeking out and participating in Continuous Improvement practices, and willingness to engage and support team initiatives. Comply with workplace safety procedures. Regular and reliable attendance, which includes punctuality and working scheduled overtime, is necessary to meet our commitment to provide quality products and service to our customer. etc.

The Assembler I: Performs repetitive assembly tasks using basic hand tools to build temperature controlled storage units, refrigerators/freezers and thawing systems or under counter temperature controlled storage units. May clean and pack units. Promotes Helmer values as demonstrated in personal productivity and quality of work, management of internal/external relationships, actively seeking out and participating in Continuous Improvement practices, and willingness to engage and support team initiatives. Comply with workplace safety procedures. Regular and reliable attendance, which includes punctuality and working scheduled overtime, is necessary to meet our commitment to provide quality products and service to our customer. etc.

The technologist is required to maintain and demonstrate cross-functional skills across all areas of the clinical lab. The technologist will be expected to successfully interface cross-departmentally with the Clinical Information Management, Client Services and LIMS groups to ensure the execution of the correct testing for all patients. These interactions will require a thorough knowledge of laboratory/scientific techniques and regulatory requirements including accreditation and governmental regulations.

As a Research Associate you’ll operate Hexagon's fungal genome discovery and molecular building block synthesis workflows, core parts of Hexagon’s pipeline which allow us to mine environmental samples for novel fungal genomes and retrieve individual biosynthetic genes to study further. You’ll apply and develop your skills running molecular and microbiological production protocols to operate and refine these pipelines using Hexagon’s suite of specialized robotic and software tools.

Applicants should have demonstrated team management skills as well as working knowledge of IATA sample shipment processes, CLIA-waivered laboratory processes, and ability to fully manage external vendors for our clinical trial testing needs. This position ensures the full reconciliation of all specimens submitted to outside client and vendors in a manner fully compliant to Good Clinical Practice under FDA guidelines.

The Quality Control Microbiology Associate I serves as a support role to clinical and commercial production The QC Microbiology Associate will assist environmental monitoring activities to ensure that quality standards are upheld for all products produced at the facility.

Hologic is seeking a Research Associate 1 or 2 responsible for designing and performing experiments while collaborating and communicating effectively. Essential Duties and Responsibilities: The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs. Performs minimally complex experiments with input from supervisor. Understands experimental goal and may provide input to the experimental design. Analyzes data from individual experiment with input from supervisor and documents work in laboratory notebook or report. Able to summarize a group of experiments. Effectively communicates with peers and supervisor. May present data in group meetings. etc.

The individual in this role will be highly motivated, enthusiastic and brings rigor and a desire to deliver on tasks with focus on the development and scale up of cell-based methods for producing AAV vectors. We seek candidates with proven ability to work independently after initial training and collaboratively to achieve optimized project plans, with the goal to deliver products that transform the lives of patients.

At Hovione, a Process Engineer's job mission is to ensure the best process engineering knowledge is applied in scaling up chemical and spray drying projects to maximize customer satisfaction ad Hovione's interests and in compliance with all Federal, State, Local and internal policies. It also includes the development of process engineering technical skills to increase the knowledge and offering on the best and state of the art technologies used in the industry. You will be responsible for: Plan and design manufacturing processes based on chemical procedures to run safely and effectively in a pilot plant/kilo lab in accordance with best known practices ensuring cGMP compliance. Contribute to the Process Hazard Analysis (PHA) of all processes under his/her responsibility and assure that all identified hazards are addressed prior to performing any activities within operations. Plan and design methods to improve efficiency in production. etc.

KEY RESPONSIBILITIES: Responsible for culture of primary human cells for purposes of cell expansion, characterization, and tissue engineering. Perform qRT-PCR to screen donor cells. Aseptic compounding and aliquoting media and buffers. Construct, launch and maintain bioreactors that are used to grow engineered vascular tissues. Perform cell-based assays. Verify process data, protocols, and manage supporting documents. Additional duties will include support of routine lab activities, equipment management, lab maintenance, preparation of experimental materials and protocols, and ensuring good documentation practices for all activities performed. Schedule flexibility required for some occasional cell culture activities needed outside of standard weekday business hours (e.g. weekend cell culture maintenance activities). etc.

Performs study start-up duties including the production of a recruitment tool, and progress notes, as well as phone screening patients and identifying participants for trials on site. Proactively develops and executes recruitment plans that meet and exceed enrollment goals. Completes training on Clinical Trial Management System and maintains proper skills to update database, complete participant reimbursement, capture referral source of participants, and create calls lists to promote recruitment.

The Setup Technician supports the Production operation by setting tools and turn over to production ready for startup. The Setup Technician is required to participate in daily meetings to ensure job accuracy and priorities. Essential Duties & Responsibilities: Train with the Senior Process Technician. Train on Robotics and End of Arm Setup. Assure GMP’s, safety standards and procedures are followed per company policies. Responsible for reviewing crossover priorities and schedule with supervisor each morning. Working from molding crossover, obtain all required elements for priority job including documentation. Verify full last shot and samples of any cavities that were blocked from tool work order packet are collected, verify this represents all cavities and then have Process Tech shut down press. etc.

The Service Hub Technician is responsible for triaging devices where critical decisions are made on the PCI, repair, updating of service record, tracking labor and material as well as updating and printing of a Service Report that is returned with the repaired device. This person must interpret and edit the repair results into device tracking system (Oracle) so that the complaint is addressed, results are technically accurate and include all required elements ensuring that the customer understands the analysis/repair activity.  Communicates with other Repair Technicians as required to clarify repair results. Essential Duties & Responsibilities: Will perform routine and complex work related to the repair and refurbished of medical devices. Troubleshoot and analyze customer device returns to problem solve root cause issues. May perform troubleshooting and repair of devices onsite at customer location. etc.

The Service Hub Technician is responsible for triaging devices where critical decisions are made on the PCI, repair, updating of service record, tracking labor and material as well as updating and printing of a Service Report that is returned with the repaired device.

Calibrate instruments and devices in the calibration and preventive maintenance program. Resolve complex repetitive instrument problems. Assist Calibration supervisor in determining preventive maintenance and calibration programs/maintenance procedures are followed. Trouble-shoot and repair instruments and systems.

Histologists at IDEXX perform dissection, grossing, embedding, microtomy, special staining, and complex tissue diagnostics on veterinary samples from dogs, cats, birds, reptiles, and all other pets big and small. Are you looking to make a difference in the lives of pets? The pet owner counts on it! ​Who should reach out? If you have specific experience in dissection, embedding, cutting, grossing or special stains. Complex Tissue a PLUS. If you desire a role as a coordinator, lab tech, leader or trainer - you will be a contributor to a team focused on operational excellence and the sharing of best practices, our team of laboratory professionals are dedicated, driven and results-oriented. This is a laboratory, so there is potential exposure to biohazards, agents known to cause zoonotic diseases, and hazardous chemicals. etc.

Our Preclinical Sciences group is looking for a Research Associate with a background in Immunology, Cell Biology or a related scientific discipline to join our growing and friendly team during this exciting time in our expansion. Duties include: Human and mouse cell culture and primary cell maintenance and isolation. Design, develop and execute in vitro cell-based immunoassays.

Conduct focused research and development under general direction of supervisor to plan, conduct, analyze, interpret, and report recommendations based on experimental results in routine setting. Develop new sequencing applications, assay workflows and assay automation methods. Plan controlled experiments to characterize key components and finished reagents

As an Engineer 1 in the Research and Technology Development department, you will support the development of novel microfluidic-based sequencing platforms. You will be part of a multidisciplinary team solving complex problems, investigating new research areas and working on integration challenges.

As a Research Associate 2 at Illumina in Systems Integration, you will work in a dynamic, team-oriented environment and help create genomic analysis tools used in the leading edge of research to advance human health by unlocking the power of the genome. Hands-on testing and integration of systems - hardware, software, chemistry, and application components

The primary focus of this position is on routine monitoring and management of the research-related activities at a clinical site. Once fully trained, a Clinical Research Associate will be expected to perform site initiation, periodic, and close-out visits. Additionally, the Clinical Research Associate will be expected to serve as a resource and research liaison between assigned sites and the Sponsoring companies or CROs.

We are seeking a Production Support Technician I to provide day-to-day operations support for all manufacturing areas. Our ideal candidate must be able to adapt to changes in the daily/weekly schedule to ensure customer demands are met. This position's schedule is Tuesday – Friday from 10am – 8:30pm (shift may vary to meet business needs). Additional responsibilities include: Perform washroom activities, staging and set up bottles for production use and maintain inventory. Assemble bottle preparation, manifold assembly and other components for manufacturing use. Responsible for training on all procedures assigned, and has the ability to be cross trained to assist in other production areas or departments as needed. etc.

As a Supply Chain Analyst, you will use analytical and quantitative methods to understand, predict, and enhance supply chain processes by assembling data, analyzing performance, identifying problems, and developing recommendations to support SCM planning and manufacturing operations.

Full/part time position, responsible for ensuring customer retention through account management and increasing revenue through marketing activities and generation of sales leads. Establishing and retaining customer relationships primarily through phone, e-mail and personal visit. Delivering requested documents, literature, and information to customers

The Associate, QC - Microbiology role will perform environmental monitoring, various testing, equipment troubleshooting/maintenance, and may assist with the drafting of SOPs, protocols, and reports to support manufacturing operations. Organizes daily workload and relevant resource requirements in an efficient manner. Important aspects of this role include excellent organization skills, flexibility, and the ability to thrive in a fast-paced, highly interactive, goal-oriented team environment with minimal supervision. etc.

The purpose of this position is to support IMMYLabs in clerical duties in a manner that is consistent with medical, administrative, legal, and regulatory requirements. This position will process, maintain, compile, and report information in a standard manner consistent with all reporting agreements.

The primary responsibility of this position is to handle incoming samples for accessioning, organizing, storing, and processing. Processing of samples will include DNA isolation of various sample types, prep for PCR and running PCR testing.

If you have work experience in a GMP/ISO 13485 manufacturing facility and/or you have experience with PCR test-kit manufacturing please be sure to include that information on your resume or in a cover letter. If you would like to be part of a team responsible for the production of large-scale ELISA diagnostic test components in a BSL-2 laboratory, and you enjoy a busy workday under general supervision with daily goals working alongside a dedicated team that consistently meets deadlines and delivers products that meet high quality standards, then we encourage you to apply for this position.

The Clinical Specialist must provide the healthcare professional with the most current information pertaining to Indivior products and their approved indications in a manner which will ensure the appropriate use of these products and achieve the business potential of the territory.

Perform quality control/development activities. Develop, validate and test analytical methods. Analyze raw materials, in-process and finished product samples using modern QC techniques and advanced analytical equipment. Assist Scientists in developing/implementing quality systems and activities.

notiv in Fort Collins is looking for a part time Receptionist/Administrative Assistant. This is a 12-20 hour a week position, Monday – Friday with a start time of 7:00 AM. The successful candidate must be dependable, polite, flexible and skillful in handling many different administrative tasks for a small medical research facility.

Assists with preparation of ELISA and Luminex™ plates according to established procedures. Major duties include assistance with reagent formulation, filtration and ELISA Plate Manufacturing activities. Assists with preparation of antigen solutions and buffers for ELISA plates according to written manufacturing documents.

The Quality Assurance (QA) Associate (Laboratory) has the primary responsibility for supporting QA activities along with supporting Quality Systems and compliance as needed. The QA Associate performs a wide variety of duties, including supporting the daily QA Bioanalytics (laboratory) departmental operations, aiding with study protocol and report oversight, performing audits (internal/external) and performing various types of documentation reviews for applicable programs involving Inovio studies.

The primary purpose of this role is to perform assembly and inspection operations over a range of new products and/or processes. Will support non-cyclical work which may include prototypes and pre-production lots in preparation for validation, clinical trials or transfers. Will also support multiple builds within the facility including lab and cleanroom environments. With guidance from Engineering on projects and using work procedures, this role provides support to the Engineering teams to meet various deadlines. May provide support to other team members or provide input to the Engineers on assembly, processes, and build/quality documentation. etc.

Integrated DNA Technologies, Inc. (IDT) is in the business of moving science forward. We are scientists working for scientists. Our innovative tools and solutions for genomics applications are breaking down barriers and inspiring others to dream big and achieve breakthroughs. Every lab has its own responsibilities and plays a crucial part in IDT’s success. Our entry-level scientific lab-based positions are split between three sub-titles, Synthesis, Purification, and Formulation. More detailed descriptions of each can be found below: The Technician II (Synthesis) synthesizes custom oligonucleotides according to the customer’s order. This generally includes synthesis, cleavage, deprotection and QC sampling of the products being made. The Technician II (Purification) purifies custom oligonucleotides according to the customer’s order. This generally includes the sorting, purification, and QC sampling of the products being made. The Technician II (Formulation) formulates custom oligonucleotides according to the customer’s specifications. This generally includes quantification, final packaging, and QC sampling of the products being made. etc.

Invenra is seeking an enthusiastic and creative Research Associate or Senior Research Associate with a strong background in molecular biology and protein engineering techniques. This individual will have the freedom to explore new technologies and innovations that can revolutionize Invenra’s current platforms. As part of the Innovation group, the successful applicant will work as part of a team that seeks to improve the efficiency or quality of immune-oncology drug discovery. Details of the job include cutting-edge library construction, recombinant protein expression, developing and optimizing various display strategies, and protein binding experiments. The position requires excellent scientific and problem-solving skills, creative thinking, the ability to try new things, and an enthusiasm for science. etc.

At Invitae, we have highly automated labs that process samples 7 days a week. To sustain volume growth and maintain high caliber instrument reliability, we are hiring an Automation Support Engineer to join the operations team. The key responsibility of the Automation Support Engineer is to provide support to the clinical lab automation and processes. The work requires excellent attention to detail, effective written and verbal communication skills, the ability to multiple tasks, and prioritize time sensitive tasks. What you will do: Provide prompt troubleshooting support to laboratory operations and escalate situations as needed to subject matter experts in, computing, automation, and laboratory processing. Support laboratory processes by troubleshooting errors related, but not limited to laboratory robotics and LIMS communication. etc.

We are seeking a data analyst to join our team. Responsibilities will include monitoring our product pipeline using custom software tools with the goal of assuring samples move through smoothly. Candidates should have experience with UNIX. They are expected to take initiative to automate tasks and troubleshoot the production process through detail-oriented analysis. An important part of this job is to be able to clearly communicate technical findings to non-technical teammates. etc.

We are seeking an experienced Bachelor’s- or Master’s-level medicinal chemist with excellent organic synthesis expertise to advance small molecule drug discovery programs toward the clinic. In this laboratory-based position, the successful candidate will partner with both internal and external medicinal chemistry teams to generate innovative solutions to synthetic and medicinal chemistry challenges within the context of small molecule drug discovery projects. She/he will maintain close interactions with computer assisted design scientists and biologists. Strong people skills and the ability to thrive in a team and goal driven environment are key attributes. This individual must also excel in communication and have strong interpersonal skills necessary to influence in a collaborative multidisciplinary environment. etc.

Just.Bio is seeking motivated and creative Associate Scientists, who desire a significant opportunity to improve worldwide access to biotherapeutics. We are looking for team members to join a fast-paced, collaborative, and multidisciplinary group to support process development for low-cost biotherapeutic manufacturing. The successful candidates will have some experience in one or more of the following areas including chromatography, filtration, electrophoresis, analytical chemistry, cell culture and/or bioreactor operations. Experience with high throughput, robotic techniques for analytical testing, chromatography, and/or protein expression, as well as statistical design of experiments and/or process modeling, is a plus. The ideal candidate has strong written and verbal communications skills and works well independently and in teams. etc.

Just-Evotec Biologics is seeking a highly motivated Cell Culture Manufacturing Associate that desires a significant opportunity to improve worldwide access to biotherapeutics. This team member will be responsible for the manufacture of mammalian cell-based biotherapeutics for clinical use under cGMP conditions. Manufacturing Associates are initially expected to execute commissioning and validation activities in addition to other start-up support activities. Post start-up activities, the associates are expected to execute process recipes, monitor equipment and processes, perform basic tasks, including sampling, and routine maintenance of lab equipment. The staff member is expected to comply and follow written procedures for safety requirements, cGMP Practices, Standard Operating Procedures and manufacturing documentation. etc.

Just is seeking a highly motivated Process Engineer in the Manufacturing Technical Operations group that desires a significant opportunity to improve worldwide access to biotherapeutics. The primary focus of this job is to support the startup of a first-of-its-kind flexible and reconfigurable cGMP manufacturing facility. The selected candidate will be responsible for supporting the procurement, commissioning, and testing of the process equipment for the new facility, including developing commissioning documentation and standard operating procedures. In addition, the candidate will be responsible for supporting process engineering activities for the new manufacturing plant, including process transfer / tech transfer for clinical and commercial biologics manufacturing, writing technical documentation within cGMP compliant systems, troubleshooting equipment, and introducing new manufacturing technologies such as continuous processing. etc.

As a Research Associate you will work alongside scientific leaders in NGS-based infectious disease diagnostics providing meaningful contributions to making an impact in the lives of patients while contributing to the company’s growth and development . You will be responsible for maintaining process excellence for a state-of-the art NGS infectious disease diagnostic assay by assisting in an established in-house manufacturing process. You will be also involved with several exciting research projects and be at the forefront of non-invasive diagnostics working alongside our scientists to deliver new products. The ideal candidate should have experience with nucleic acids, NGS, or other molecular biology assays to conduct laboratory experiments on research projects under the direction of senior lab personnel. etc.

Responsible for executing experimental protocols and performing elementary data analysis in biopharmaceutical development laboratories. Job Description: Regularly exercises technical discretion in the execution and interpretation of experiments that contribute to project goals. Makes detailed observations and carries out elementary data analysis. Understands experiments and conducts troubleshooting analysis. Maintains and updates knowledge of instrumentation. Notebook upkeep and writing skills. Maintains familiarity with current scientific literature; maintains professional expertise through familiarity with scientific literature. Assures proper labeling, handling, and storage of all chemicals used in the area; assures proper labeling and disposition of hazardous waste in satellite areas; adheres to all safety requirements and follows safe procedures, and attends all required safety and health training, including handling hazardous waste. etc.

Job Summary: Coordinate and perform cGMP manufacturing operations for manufactured biopharmaceutical products. Ensure the effective use of material, equipment and personnel while making products at high quality levels. Job Description: Assist in execution of procedures for cell culture manufacturing, purification, or support area of manufacturing using SOP's and batch records. Use equipment and techniques related to support, mammalian cell culture and/or harvest and purification. Responsible for completing paperwork for each task, cleaning procedures, aseptic processing techniques, Good Manufacturing Practices (GMP) and laboratory safety practices and procedures. etc.

Responsible for a wide variety of cell-related functions, including producing cells, intermediate product, and manufacturing final product for commercial distribution. Follow SOPs, perform daily tasks in a clean-room, retain records and write reports. May also be responsible for troubleshooting. Job Description: Assist in execution of procedures for cell culture manufacturing, purification, or support area of manufacturing using SOP’s and batch records. Responsible for various duties that are required to produce product including but not limited to cell expansion; cell feeding, harvesting, counting and freezing; product seeding; growth system maintenance; labeling, packaging and freezing of product; and culture media preparation. Follow specific techniques and operations while demonstrating an understanding of cGMPs and how they apply to specific responsibilities. Use equipment and techniques related to support, mammalian cell culture and/or harvest and purification. Responsible for completing paperwork for each task, cleaning procedures, aseptic processing techniques, Good Manufacturing Practices (GMP) and laboratory safety practices and procedures. etc.

Responsible for executing experimental protocols and performing elementary data analysis in biopharmaceutical development laboratories. Job Description: Regularly exercises technical discretion in the execution and interpretation of experiments that contribute to project goals. Makes detailed observations and carries out elementary data analysis. Understands experiments and conducts troubleshooting analysis. Maintains and updates knowledge of instrumentation. Notebook upkeep and writing skills. Maintains familiarity with current scientific literature; maintains professional expertise through familiarity with scientific literature. etc.

Open position available in the rapid analytics testing group. Responsible for analytical testing of client samples. Testing may include using client-based methods or some method development. Ideal candidate is able to quickly and accurately generate results. Technical writing skills are a plus. Job Requirements: Familiarity with biophysical and protein characterization techniques, such as: SV-AUC, CD, DSC, FTIR, HPLC, UV-Vis. Design and execution of experiments. Routine statistical analysis on generated data sets using JMP or equivalent statistical software. Attention to detail in documentation of experiments in electronic laboratory notebooks. etc.

Job Summary: Coordinate and perform cGMP manufacturing operations for manufactured biopharmaceutical products. Ensure the effective use of material, equipment and personnel while making products at high quality levels. Job Description: Assist in execution of procedures for cell culture manufacturing, purification, or support area of manufacturing using SOP's and batch records. Use equipment and techniques related to support, mammalian cell culture and/or harvest and purification. Responsible for completing paperwork for each task, cleaning procedures, aseptic processing techniques, Good Manufacturing Practices (GMP) and laboratory safety practices and procedures. etc.

The Lab Maintenance Technician I performs maintenance, testing, troubleshooting, calibration and repair on support and laboratory systems. May also analyze data, interpret results or contribute to troubleshooting activities. Works on assignments that are moderately complex in nature in which judgment is required in resolving problems and making routine recommendations. ESSENTIAL FUNCTIONS: Process new and/or retired equipment. Perform calibration, repair, and preventive maintenance on support systems and laboratory equipment. Perform and/or verify calculations related to calibration and/or maintenance events. Review information and documentation for accuracy. Support the recertification of support systems and laboratory equipment. Supports activities of the Operations Department, as assigned. etc.

Responsible for preparation of reagents and solutions as well as sample processing under required regulatory documentation. Analyzes data, interprets results, and contributes to troubleshooting activities, such inventory of chemicals, washing glassware, waste disposal and/or general cleanup. May provide basic training for other laboratory personnel. Key Job Responsibilities: Typical responsibilities of the Analyst II may include, but are not limited to, the following: Process and/or analyze samples. Prepare and label laboratory solutions. Perform and/or verify calculations related to reagent preparation and/or sample analysis. Conduct sample inventory and verify sample identities. etc.

Depending on prior experience, the Analyst I will be responsible for sample preparation/extraction, preparation of reagents and solutions under required regulatory documentation, analysis of data, interpretation of results, contributing to troubleshooting activities, performing chemical inventory, and general laboratory activities such as washing glassware, waste disposal and/or general cleanup. Once fully trained, the Analyst may provide basic training for other laboratory personnel. With demonstrated progress and initiative, the candidate will also have opportunities for learning value added skills. Key Job Responsibilities: Typical responsibilities may include, but are not limited to, the following: Process and/or analyze samples of various biological matrices. Prepare and label laboratory solutions or buffers. etc.

As a Process Engineer I, you will be responsible for designing and executing engineering activities and lab studies in support of process automation, technology development, technology evaluation, equipment qualification, process validation, and GMP manufacturing. Additional responsibilities include analyzing and presenting experimental results, drafting / reviewing protocols, production procedures, and technical reports including documentation for regulatory filings. You will work within the process technology and materials development team to design and scale-out cell therapy processes, evaluate new materials, implement innovative solutions, and support or improve existing technologies to advance Kite’s product portfolio. You will work closely with analytical, process design, validation, manufacturing sciences, operations, business strategy, and external collaborators as needed to achieve the above objectives. etc.

As a Research Associate in Process Design, you will provide process development support for New INDs, technology transfers, process validations and GMP manufacturing for Kite’s engineered autologous T cell therapy products. Additionally, you will draft and review protocols, production procedures, and process development reports. You will work with the Process Development team to design and scale-out cell therapy processes, manage equipment qualification and support process validation, as well as draft documentation for regulatory filings to advance Kite’s product portfolio. Key responsibilities: Hands on execute and collaborate on process design laboratory studies to support process development, optimization and characterization and essential process improvements. Perform hands on work in a cell culture lab and process training for GMP clinical production. etc.

KSQ Therapeutics, Inc. is seeking an exceptional and highly motivated Senior Associate Scientist/Scientist to join the Pharmacology group. The successful applicant will contribute to in vivo pharmacology efforts to support the advancement of our pre-clinical Oncology and Immuno-Oncology small and large molecule pipeline. This is a unique opportunity to learn and develop in a highly dynamic and interdisciplinary environment. Responsibilities: Independently execute on a wide variety of in vivo techniques across multiple projects with delivery of high quality data. Work collaboratively within department and across departments to effectively achieve project goals and timelines. Work enthusiastically as part of an interdisciplinary team. etc.

Sample Management Associate provides support to Sample Coordinator and performs administrative tasks in the Sample Management Department. Follows SOPs, and fulfills laboratory requests with minimum direct supervision. JOB RESPONSIBILITIES: Performs duties and training to acquire the skills required for sample and standard handling in support of the laboratory. Handling of samples received in Quality Control Laboratory. Follows SOPs, and fulfills laboratory requests with minimum direct supervision. Quality Control related tasks like receiving, documenting, distributing and reconciliation of all samples received in the laboratory. etc.

Executes the activities of QC Microbiology Laboratory by following approved microbiological and chemical test procedures and ensure their delivery in an accurate and timely manner following proper safety precautions. Also provide QC microbiology support to the Aseptic Manufacturing and validation process. DUTIES & RESPONSIBILITIES: Familiar with Drug Regulations, Pharmacopeia’s and Regulatory requirements. Authoring SOP’s and Test Methods when required. Assurance of cGMP and GLP compliance in the QC Microbiology Laboratory. Responsible for laboratory cleanliness and biohazard removal. etc.

Perform analytical testing of raw materials, in-process materials, stability samples, finished products and product development products using different analytical techniques. JOB RESPONSIBILITIES: Operation, Calibration, Qualification, Preventive maintenance and routine trouble shooting of analytical instruments like UPLC, HPLC, GC, AAS, UV spectrophotometer, Dissolution apparatus, Laser Diffraction Particle Size analyzer, etc. Evaluate existing, develop and validate new analytical methods of drug products and drug substance as per FDA, USP and ICH guidelines by different analytical techniques. Document all performed analysis as per cGMP, USFDA and 21CFR211.194 guidelines. Follow cGMP (current Good Manufacturing Practices), GLP (Good Laboratory Practices), 21CFR211.22, 21CFR211.28 and 21CFR211.170. etc.

To provide financial support to the Senior Analyst and Project Manager as assigned. The mission of the position is to support the accurate reporting of the financial position of each project internally. Essential Functions (including but not limited to): Responsible for project set-up in an ERP system, client billing support, and other financial aspects of assigned projects. Assist in financial support to ensure the operational effectiveness of the project. Maintain all project data in the ERP system and on Sharepoint. Prepare reporting and financial analysis for the Finance team and issue findings and variances to plan. Identify and highlight potential issues related to project financial risks that impact company profitability. etc.

Care of animals including feeding, cleaning, treatment and preventive medicine. Daily production and maintaining the animal areas of the facility. Responsibilities Include (but are not limited to): Animal care AM/PM daily. Complete daily production which may include injections, bleeding, milking etc. Maintain animal living areas. Document findings and job completions in the required logs. etc.

This position will be responsible for the purification of antibodies at the Everett facility. Responsibilities Include (but are not limited to): Routine buffer preparation for all processes being performed in the department. Protein A and Protein G purification of Normal igGs and other antibodies. Write and revise Standard Operating Procedures (SOP’s) and Batch Records (BR) as needed. Assist in filing, labeling and finished product good inspection. Operate basic Laboratory and Analytical equipment. Compliance with all Standard Operating Procedures (SOP’s) in relation to Protein Purification. etc.

The ideal candidate must be able to work independently and have excellent interpersonal relationship skills with flexibility to adapt to fast pace environment with changing priorities. Job Duties: Provide consulting services for LBG client including, but not limited to: Evaluation and disposition of materials with the assurance that the materials were produced in conformance to all applicable policies/procedures of the Company's compliance with all governing regulations. Coordinate and/or support the preparation of procedures, processes and quality improvements. Assists in the coordination of significant quality events including fact-finding, investigation support, coordination of clinical quarantine and recovery actions. Collaboration with clients and vendors to ensure robust processing and continuous improvement. etc.

The Manufacturing Technician is responsible for carefully following manufacturing instructions and adhering to applicable company quality standards and requirements to ensure the proper manufacturing of our collagen vascular graft. Responsibilities: Manufacture vascular graft products as required to support all customer, internal, clinical, and other demand. Package vascular grafts as required as per current process specifications. Maintain timely and accurate documentation of all manufacturing activities, including but not limited to device history records and inventory counts. Complete scheduled production runs in an efficient, timely manner to meet schedules. Participate in Continuous Improvement projects or events as requested. Assist with inventory counting activities as required. etc.

The GMP Manufacturing Technician I position is responsible for performing manufacturing activities in compliance with company procedures and external regulatory requirements as directed by the departmental supervisor, manager or director. Areas of Responsibility: To perform this job successfully, an individual must be able to perform each essential function satisfactorily. Essential Functions: Perform manufacturing activities according to written protocols, as directed by the departmental supervisor, manager or director. Maintain batch records, equipment logs and other production records as directed per company procedures. Maintain a clean an orderly laboratory environment. etc.

The GMP Manufacturing Technician I performs tasks associated with the production of modified oligonucleotides in a high throughput time sensitive manufacturing environment. A GMP Manufacturing Technician I may be called upon to work in any production shift in the GMP Manufacturing Department. Areas of Responsibility: Performs all assigned job functions per documented procedures as directed by Supervisor. Performs daily equipment and lab maintenance tasks. Able to follow all documented procedures. Other duties as assigned. etc.

The Lab Assistant I will perform tasks in support of the Chemical Production department in a high throughput, time sensitive manufacturing environment. Perform assigned tasks using the established protocols and methods on the appropriate equipment and within the given final specifications and timeline. Effectively communicate and coordinate with Chemical Production team members, affected employees in other departments, and the Production Support Supervisor to assure the most efficient use of time and resources.

The Oligo Production Technician I is responsible for performing day to day production activities in the custom oligonucleotide (oligo) production lab. Production activities will be performed in a timely fashion and in compliance with company procedures. Performs all assigned job functions per documented procedures or as directed by the supervisor/manager. Perform oligonucleotide synthesis/purification according to established procedures.

We are seeking individuals who are passionate about research, bring out of the box thinking and take bold steps to develop innovative technologies with applications in the ubiquitin research field. Successful candidates will have basic knowledge of biochemistry and molecular biology techniques, in particular experience with protein expression and purification and cloning. Knowledge of the ubiquitin proteasome pathway is desired. etc.

Associate scientist needed in the area of pharmaceutical drug delivery research. Responsibilities include conducting laboratory experiments in support of formulation and process development. Qualified candidates will possess a BS/MS in life Science, chemical engineering or related field or 1-3 years experience in a pharmaceutical or chemistry laboratory. Knowledge of laboratory practices and demonstrated skills in analytical instrumental techniques (e.g. HPLC) are preferred. Excellent communication skills needed for preparing and following standard test methods and reporting experimental results.

Locus Biosciences is seeking a highly motivated and entrepreneurial applicant to join our research and development team as a full-time Research Associate. This position is well suited for those that can accomplish defined work, as well as assist in approaching and solving complex scientific problems. This individual will be responsible for assisting in the generation, production and characterization of novel antimicrobial products. The ideal candidate will be able to independently conduct general microbiological and molecular biology research, and assist in the development of our broader research goals. This individual must be able to communicate effectively in formal and informal settings and be able to work well within a team. Candidates should have prior laboratory experience and be competent at basic molecular biology techniques. etc.

Locus Biosciences is seeking highly motivated applicants to join our research and development team as a full-time Research Technician within the Translational Medicine group. This position is well-suited for highly motivated technicians that have a desire to push product development forward into critical preclinical in vitro and in vivo testing across a variety of therapeutic indications. This individual will work directly with scientists in both Development Translational Medicine as well as the Discovery group to develop and execute in vivo animal models and analyze tissue samples using various molecular and biochemical assays. The ideal candidate will be well organized and have a scientific background as well as experience with microbiology techniques and in running animal models. Candidates must have the ability to manage multiple concurrent projects, but be flexible, adjusting plans as the data dictate. The individual must be able to communicate effectively and be able to work across interdisciplinary teams. etc.

Manage, coordinate, and maintain CGMP documentation, procedures, and records to ensure only controlled copies are reviewed, approved, issued, distributed, and archived. JOB DUTIES: Maintain Document Change Request/Quality System event databases and Master Documents/List. Maintain Designated Satellite Areas for controlled paper based record management system. Facilitate Client Batch Record Creation/Modifications/Approvals. Issue, maintain and archive Controlled Documentation/Batch Records/Testing Data Sheets/Equipment Log Books/Quality System event documents and Logs. Track and facilitate Periodic SOP reviews. Manage Record/Document Filing system. Proof and edit document changes, as necessary. Assist in client audit preparation and reconciliation. Other duties as assigned. etc.

The Assembly Associate I, Consumables will be responsible for: Building of cassettes for use by Engineering, Development, Clinical Studies, and product sales. Following approved cGMP manufacturing instructions and personnel are required to complete a history record of the lot built per company Quality System. Providing feedback on the processes to assure continuous improvement by noting differences in parts, assemblies, tools, fixtures, or process steps. What you will do: Coordinate with other assembly associates daily in support of integration testing, manual instruction development and production process development. All to support a quality process. Hands-on assembly, test and troubleshooting of system builds and re-work. etc.

The Assembly Associate I, Consumables will be responsible for: Building of cassettes for use by Engineering, Development, Clinical Studies, and product sales. Following approved cGMP manufacturing instructions and personnel are required to complete a history record of the lot built per company Quality System. Providing feedback on the processes to assure continuous improvement by noting differences in parts, assemblies, tools, fixtures, or process steps. What you will do: Coordinate with other assembly associates daily in support of integration testing, manual instruction development and production process development. All to support a quality process. Hands-on assembly, test and troubleshooting of system builds and re-work. etc.

Lundbeck is seeking a Quality Control Associate to support QC testing activities for projects in both the early and late stage of clinical and commercial development. The ideal candidate is detail oriented, organized and will have some experience in a Quality Control or other scientific laboratory or setting. ESSENTIAL FUNCTIONS: QC Sample Shipping and Sample Management. Coordinate and track sample shipments between various departments at Lundbeck and multiple CMOs/contract testing labs including international shipments. Lead a weekly multi-departmental sample shipping working group meeting. Proactively communicate shipping timelines from contract testing labs to other QC personnel and other Lundbeck contacts, as required. etc.

This is an intermediate experienced engineer/associate position that will play an important role in developing stable cell lines and robust cell culture processes to be used in clinical manufacturing. Experience will dictate the exact title. The position will report to the Manager of Cell Line Development. Essential Job Responsibilities: Develop stable cell lines: Host cell transfection with target plasmid. Minipool screening and single-cell cloning. Shake flask fed-batch studies to support stability studies and top clone selection. etc.

Packaging Line Operator is responsible for tending machines and conveyors at various stages of the packaging line to maintain efficient, continuous packaging of the product for shipment. Essential Functions: Components are in Place and Filled. Sets up assigned station(s) on the line including assembly of basic equipment and preparing materials needed (e.g. bottles, caps, cotton, etc.). Tends/operates station(s) during production run to insure proper operation and keep station filled with supplies or product. Weighs product at various stages of the packaging process. Performs checks/tests required for applicable station(s). Adjusts containers/materials for proper placement and remove defective pieces. Starts and stops equipment when required. Performs hand-packaging and material-handling functions. etc.

Blend defined quantities of designated raw materials (per specific manufacturing instructions) into final dosage blend stage. Executes all Production processes while strictly adhering to cGMP, Standard Operating Procedures, documentation protocols, environmental health and safety guidelines and any other related regulations that could apply. The Blending Technician is expected to fully participate in both departmental projects and any quality working teams that may be applicable. Supports the leader and subject matter (SME) expert in their area(s) of responsibility. Supports production, operations projects and process improvements. Maintains accurate and compliant documentation on all activities. etc.

The Quality Tech II analyzes process samples as received and performs non-routine analysis as requested. She/he will analyze finished goods and raw materials by chemical, physical, and instrumental means to ensure quality as needed. Must be able to work a 12 hour shift schedule of (7pm-7am) rotating shift with potential of night shift. In addition to occasional overtime as needed. ESSENTIAL FUNCTIONS: Performs in process testing for internal customers. Performs finished goods, returned goods, and stability testing for external customers as needed. Performs specified analysis on all process controls samples and reports in a timely manner by telephone or computer entry using approved written procedures and proper laboratory techniques. etc.

Blend defined quantities of designated raw materials (per specific manufacturing instructions) into final dosage blend stage. Executes all Production processes while strictly adhering to cGMP, Standard Operating Procedures, documentation protocols, environmental health and safety guidelines and any other related regulations that could apply. The Blending Technician is expected to fully participate in both departmental projects and any quality working teams that may be applicable. Supports the leader and subject matter (SME) expert in their area(s) of responsibility. Supports production, operations projects and process improvements. Maintains accurate and compliant documentation on all activities. etc.

Blend defined quantities of designated raw materials (per specific manufacturing instructions) into final dosage blend stage. Executes all Production processes while strictly adhering to cGMP, Standard Operating Procedures, documentation protocols, environmental health and safety guidelines and any other related regulations that could apply. The Blending Technician is expected to fully participate in both departmental projects and any quality working teams that may be applicable. Supports the leader and subject matter (SME) expert in their area(s) of responsibility. Supports production, operations projects and process improvements. Maintains accurate and compliant documentation on all activities. etc.