Links to 843 Entry-Level Biotechnology & Life Science Jobs

10x Genomics is looking for an outstanding individual to join its consumable manufacturing team. This individual will be responsible for production consumable products associated with Next Generation Sequencing chemistries. This role requires excellent laboratory skills in performing production operations consistently. The ideal candidate will have an education background in one or more of the following disciplines: Molecular Biology, Analytical Chemistry, Chemical Engineering, or equivalent. Experience in production and QC of similar products in a manufacturing environment a plus. etc.

Primary Responsibilities include but are not limited to the following: Follow standard operating procedures to assemble, test and package products. Follow all job safety recommendations. Enter data into ERP systems. Experienced in the use of hand tools, powered tools including routers, sanders, dremmel tools and measuring devices. Must be able to work with minimal supervision but also to take direction from team members in a small but highly motivated manufacturing team. Must have excellent housekeeping skills and be able to work with a very sticky Epoxy adhesive and 2-propanl without causing contamination of product, tools and equipment. etc.

The Development Document Writer I is accountable for authoring Development's quality documents by leveraging knowledge and expertise in writing standards and working with stakeholders to ensure the end to end processes are well-defined and articulated clearly in alignment with AbbVie's quality document system. Responsible for ensuring quality document standards are applied when authoring new and updating Development's quality documents. Responsible for understanding AbbVie's Quality System and applying the knowledge when authoring new and updated Development's quality documents. Provides internal stakeholders with the understanding of AbbVie Quality System and its practical application. etc.

The Research Associate for Quality Control (QC) is a key member of the Operations Team under the direction of the Team Lead for Consumable Quality Control. This individual will be responsible for testing of incoming product both analytically and biologically in support of manufacturing. This will include, but not limited to, operation of pH/conductivity meter, HPLC-MS, refractometer and in-house biotechnology systems. This person will be part of a team that executes these tasks on a daily basis. The ideal candidate will be a team player, demonstrate excellent communication skills, be flexible, and excel in a fast-paced environment. etc.

The Facilities Technician will handle multiple duties and daily activities as well as drive Facilities operations to meet deadlines in support of activities including, but not limited to, operation and maintenance of building systems, inventory management, conducting routine inspections, safety compliance, vendor management, and basic manual labor. etc.

The Production Associate position will be responsible for processing client samples using high throughput DNA sequencing technology. This role will work within a team of other Laboratory Technicians in a fast-paced, high production setting to process research and clinical diagnostic samples. The shift for this job is 7am-4pm, Sunday's through Thursday's. Responsibilities: Perform DNA/RNA extractions, PCR amplification and high-throughput sequencing assays on DNA libraries. Perform QC and carry out routine tasks accurately and following strict methodologies. Completes assignments of complex nature requiring a basic knowledge of techniques and practices related to the research area. Supports business goals, knowledge and skills, and cross-functional teamwork. Keep accurate and detailed records for all workflows. Ability to work independently and carry out optimization and validation experiments. etc.

Scope: Learning to disassemble, clean and reassemble production equipment to prepare for processing. Learning to conduct pre-processing staging to assure that required raw materials are assembled, weighed, and meets specified consistency as outlined in written procedures. Learning to operate the process equipment to create product that meets predetermined specifications. Learning to monitor and record critical process parameters. Learning to make necessary adjustments to assure finished product meets customer specifications. Learning to transfer processed materials through production equipment to include dryers, filtration systems, blenders, and sieving equipment. Learning to package finished product and transfer to warehouse. Learning to operate solvent recovery system to assure cyclohexane ingredient is of the purest form. etc.

Responsibilities: Perform high complexity laboratory tests in accordance with SOPs and CLIA/CAP regulations. Evaluate and interpret results. Maintain accurate documentation and records (accessioning through result reporting). Proper handling of clinical samples. Maintain and operate lab equipment and instruments. Order supplies and reagents. Additional tasks may be assigned. etc.

The Manufacturing Associate performs GMP manufacturing operations safely, reliably and in compliance with stated processes. PRINCIPAL RESPONSIBILTIES: Execute unit operations described in standard operating procedures and batch records. Perform bioprocess operations such as filtration, purification, cell culture or recovery. Perform review of GMP documentation. Clean, assemble/disassemble, sterilize and operate primary process equipment. Complete required processing documentation including deviation reports, change control, product change over, etc. Ensure compliance with company quality systems, safety procedures, and other company policies. etc.

The Manufacturing Associate performs GMP manufacturing operations safely, reliably and in compliance with stated processes. PRINCIPAL RESPONSIBILTIES: Execute unit operations described in standard operating procedures and batch records. Perform bioprocess operations such as filtration, purification, cell culture or recovery. Perform review of GMP documentation. Clean, assemble/disassemble, sterilize and operate primary process equipment. Complete required processing documentation including deviation reports, change control, product change over, etc. Ensure compliance with company quality systems, safety procedures, and other company policies. etc.

The Quality Control Associate I will perform QC analysis and document activities according to SOPs following good manufacturing processes (GMP). This individual will also demonstrate the ability to learn QC methods, procedures and systems. PRINICIPAL RESPONSIBILITIES: Supports projects / initiatives / team goals by delivering on all assigned tasks. Analyzes issues and makes decisions based on standardized processes and procedures under direct supervision. Seeks opportunities for continual learning. Receives close and regular instruction, guidance and direction from others in the form of steps and tasks. Perform general QC testing such as pH, Osmolality, Protein Concentration. etc.

The Research Associate Assay Development Preclinical Research and Development is responsible for support of the Assay Development team by developing,qualifying and troubleshooting quantitative, semi-quantitative, and qualitative assays in support of research, nonclinical, and clinical programs. The Research Associate will report directly to the Supervisor, Assay Development Preclinical Research & Development. Develop and qualify new assay methods in support of IND enabling non-clinical animal studies, including in vitro cell-based assays, immunoassays, and molecular assays. Plan strategies for and participate in the development, qualification, and transfer of quantitative and semi-quantitative bioanalytical methods to support product release. May assist in preparing technology transfer, assay validation and clinical sample testing at CROs. etc.

We seek talented Analytical Scientists at various levels to join our expanding R&D team. You will be responsible for methods and process development for ANDA topical, suspensions and solutions, nasal sprays, inhalations, sterile injectable and ophthalmic products. You will develop and validate new analytical methods, conduct stability studies and perform sample testing to support regulatory submissions. ESSENTIAL FUNCTIONS: Independently develop analytical methods for drug substances, drug product, preservatives and degradation/impurities in the new drug products. Perform validation experiments as per approved method validation protocols, Company SOP and ICH guidelines. Perform in-process, finished product/release and stability testing of dosage forms as per the approved methods. Perform Extractable/leachable studies for container closure systems of drug products. etc.

Responsibilities: Follows established procedures, protocols, or best practices to analyze stability and development samples. Perform assigned tasks under minimal supervision in support of approved projects and documents work properly. Executes a well-designed study, conducts testing and analyzes data without deviation following established procedures under general supervision. Applies general technical skills to complete assigned work, and solves routine problems of limited scope. etc.

American Regent, Inc., a Daiichi Sankyo Group Company, develops, manufactures, and supplies high quality sterile injectables for healthcare providers, clinics, hospitals and veterinary practices across the United States and Canada. We have locations in New York, Ohio, and Pennsylvania and sales territories nationwide. Nature and Scope: A technical position involving equipment repairs and maintenance activities intended to keep the facility equipment (i.e. process, utility, and general equipment) within compliance of cGMPs. etc.

Assist in the design and development of SEPs and engineering projects for new and existing products.    Identify new designs, methods or processes to reduce cost and improve quality.  Associate Engineers will be given a lead role on projects and SEPs with appropriate scope. Provide technical support to vendors, and manufacturing and assembly departments, and assist with the resolution of problems and questions as required.

To test a variety of assemblies and sub-assemblies of printed circuit boards using various test measurement equipment and automated test systems. Perform basic to intermediate level troubleshooting on digital and analog circuitry to component level. Read schematics and engineering drawing.

The Quality Assurance Inspector I monitors and ensures all incoming raw materials, packaging components and returned goods are sampled, inspected and tested (where applicable) for the purpose of determining compliance with established specifications. The QA Inspector I must monitor and ensure all phases of drug manufacturing are in compliance with established specifications; receive, inspect, release and control of labels and outserts, to ensure quality compliance before, during and after each packaging run. Essential Functions: Perform Inspection, sampling and testing where applicable on all incoming raw materials, packaging components and returned goods following detailed written procedures. etc.

The Lab Technician will be responsible for performing daily calibration of lab equipment, reports and maintain results. Essential Functions: Conduct daily calibration of instruments by utilizing small equipment like Balances, pH meters, Desiccators and Refrigerators. Login and maintain incoming samples for analysis in APR web. Prepare laboratory supply, chemical purchase request and maintain chemical inventory in APR web. Maintain column log books for HPL, GC and UPLC analysis. Dissolution media preparation and keep dissolution apparatus clean after each use by Scientist. Document reference standards and impurities in incoming material log book and update as needed. etc.

The Contracts and Government Pricing Associate assists in managing pricing for commercial contracts and assists in managing medicaid. Position Responsibilities: Pricing for Commercial Contracts: Direct support/backup for Contract Support Department. Contract Manufacturing; Wholesalers/Distributors; Retailers and Mass Merchandisers; Group Purchasing Organizations; and Buying Cooperatives. etc.

This position is responsible for independently performing microbiological testing, as defined by governing standard operating procedures. This is an entry level professional position in the Quality Control Microbiology Laboratory. Position Responsibilities: - Perform microbiological testing on raw materials and finished product samples. Prepare standards, stock cultures, microbiological media and samples in accordance with approved methods. Identify microorganisms. Set-up and confirm suitable operation of equipment and instrumentation. Collect data and generate/report results in accordance with governing test methods and SOPs. Perform review of data collected under approved methods. Provide accurate assessments of data integrity, and document findings. Perform calibration, preventative maintenance and repairs as needed on instrumentation. Perform cGMP tasks such as laboratory housekeeping, auditing documentation, and maintenance of microbiology laboratory supplies.

This position is responsible for providing support to the Validation Department in execution of validation activities necessary to support department objectives and procedures. Position Responsibilities: Performance validation protocols to include but not limited to: Installation and Operation Qualification of Equipment, Process Validation and Qualification, Environmental Monitoring, Cleaning Validation swabbing. Coordination of required documentation in support of the validation packages: routing document for review and approval, coping / scanning / filing of documents. Preparation of sampling to include generation of sample labels and coordination of physical resources required to perform sampling. Audit of Validation protocol documentation to ensure that the information contained in the validation package is consistent with the supporting raw data. etc.

This position is responsible for support of QC testing activities. These responsibilities include: Position Responsibilities: Washing Laboratory Glassware. Sampling of Raw Materials. Inspection of Packaging Components. Minor Raw Material Testing. Filing of Laboratory Records and Documents. Special Project Assignments. Auditing Samples, Logbooks and Data Records.

The Applied Medical Simulation team was developed by Applied Medical as a result of the company’s founding purpose to improve patient outcomes through the delivery of affordable, accessible and high quality healthcare solutions. We maintain that surgical education, developed in close collaboration with the surgical community, is critical to advancing skills and improving clinical outcomes. As an Engineer I you will be responsible for working within the framework of a team and performing the following activities: Communicate with product experts, UI designers, and engineers to fully understand business requirements. Break down business requirements into clear and actionable tasks. Turn business requirements into clean, testable, and maintainable code. etc.

As a Production Associate on 2nd shift, you will be responsible for working within the framework of a team in a cleanroom or manufacturing environment, and performing the following activities: Perform all manufacturing operations in a cleanroom or non-cleanroom environment such as assembly, inspection, and machine operations. Comply with Applied Medical Quality Systems (QS) including SOPs, MIs, QIs and TMs. Comply with safety and company policies. Comply with engineering drawings, shop order operations and sequence. Follow production schedules and meet production and quality goals. Perform manufacturing operations efficiently with or without tools and/or equipment. etc.

This position is responsible for performing routine testing of raw materials, intermediates, and finished product to support product development. Works with minimal supervision to assist in analytical method development and pre-validation. Interacts extensively with Product Development and Quality functions to proactively deliver Analytical Development supports and to leverage analytical sciences to characterize and understand formulations and novel 3DP (three-dimensional printing) manufacturing processes. In addition, this position is also responsible for writing protocols, development reports, and SOPs (standard operating procedures); training others on analytical techniques; being familiar with USP/NF (United States Pharmacopeia/National Formulary) analytical procedures; and maintaining an understanding of cGMPs (current Good Manufacturing Practices) and ICH (International Conference on Harmonization) guidelines. etc.

The Quality Control Technician performs dimensional and functional testing on Aptar Congers product to ensure compliance with established quality standards and customer specifications. The Quality Control Technician is responsible for documenting and communicating nonconformities to supervision. All Quality specifications, work instructions, as well as actions that support team work, safety, efficiency and cGMP adherence are to be followed. Primary Duties and Responsibilities: Perform incoming inspection and disposition of components. Perform analytical testing such as Spray Pattern testing, measurements, in-process and release testing as per the Quality specification. Initiate Discrepant Material Report for non -conformities. etc.

The Regulatory Affairs Associate, reporting to the Regulatory Affairs Director, will help develop, implement and maintain the Regulatory Processes within the Quality Management System (QMS), including creation and maintenance of the documentation associated with filing for high risk medical device for the US and OUS submissions. RESPONSIBILITIES: Assist with the development and implementation of regulatory procedures. Assist in the communication with regulatory agencies. Support creation and manage filings for IDE, 510(k), PMA and EU Technical Files. etc.

The purpose of this position is to provide support services by means of executing the analysis of in-process, finished product, and stability test samples. Further support services include Environmental Monitoring and Raw Material receipt activities. QC personnel are responsible for compliance with QC policies and procedures within the QC laboratory, company policies, and cGMP guidelines. This position will report to the Director, Quality Control. General Responsibilities: Directly contributes to daily laboratory operations for QC Chemistry and Microbiology, in full compliance with applicable SOPs and safety guidelines. Analyzes on a routine basis in-process, release, and stability test samples in accordance with established QC test methods and specifications. etc.

This position is responsible for maintaining the cleanliness of the laboratory, the organization of supplies, reagents and standards. Additionally, this position is responsible for the daily calibration and/or verification of the balances and pH meter. The employee will have basic knowledge of commonly used laboratory concepts, practices, procedures and instrumentation and will perform limited tests under supervision. This is a safety sensitive position as defined by state and federal laws that will require working with hazardous materials and/or handling medicine. As a "safety sensitive" classification, you will be subject to drug and alcohol testing, including random testing. etc.

The mission of Arrakis Therapeutics is to extend small molecule medicines into new realms of biology by discovering and developing compounds that selectively target RNA (“rSM”). By targeting distinct RNA structure/function relationships, Arrakis is generating drug candidates with novel mechanisms of action for molecular targets that are challenging to drug in disease areas with high unmet medical need. As Arrakis uses next generation sequencing (NGS) to enable the RNA structure and function assays that are central to our mission, the Research Associate will have an opportunity to make a large impact on our effort to establish world-class NGS methods and perform sequencing-based assays. etc.

Arrowhead Research seeks a full time Research Technician to join its drug targeting team at its research and development facility in Madison, WI. The candidate should be highly motivated, and enjoy working with a team of scientists in a fast-paced and highly cross-disciplinary environment. The individual will be primarily responsible for providing technical assistance in RNA and DNA isolations, cell culture, and general laboratory maintenance.

Arrowhead Pharmaceuticals is seeking an Associate Scientist to join the Chemistry Department. The successful candidate will primarily focus on bioconjugation, analytical chemistry, formulation, and some small molecule organic synthesis. S/He will be joining a team of highly motivated and experienced scientists, and will contribute to the success of Arrowhead programs. S/He will be expected to: Perform bioconjugation, purification, and characterization of oligonucleotide conjugates. Identify critical issues/steps in a conjugation and solve the problems in a timely fashion. Maintain a well-documented laboratory notebook. Track progress against project timelines, generate regular status updates, and communicate progress and issues to management. etc.

Arrowhead Pharmaceuticals is seeking a highly motivated individual to become a part of its scientific team. We have an immediate opening for an Associate Scientist to work as a Chemist in the Chemistry, Manufacturing, and Controls Group focusing on oligonucleotide synthesis development. This is an ideal position for an individual with an organic or biological chemistry background who has an interest in projects related to novel technology in synthesis and purification of oligonucleotides and bioconjugates. The successful candidate will be expected to: Work closely with senior chemists on development of new synthetic approaches to desired compounds with an eye toward large-scale synthesis. Cooperate with other chemists in the group in preparation of complex organic constructs. Perform solid-phase synthesis and purification of oligonucleotide drug candidates. Analyze small-molecule and macromolecular targets using standard methods. etc.

Main Objective: Performs production assembly work of light electro-mechanical assembly operations of moderately high complexity with close attention to detail following manufacturing assembly procedures. Essential Duties and Responsibilities: Manufacture electro-mechanical medical products to specified work orders. Follows engineering drawings, manufacturing assembly instructions and standard operating procedures. Inspects own work as well as the work of others. Operate a variety of hand tools and light manufacturing equipment. Perform tasks such as but not limited to installing circuit boards, power supplies, face plates, product labels, cables and wire harness using screws and adhesives. etc.

Arthrex is actively searching for a Product Manager Associate, to actively participate in our fast paced and dynamic bipolar RF product line. The candidate will lead our product management initiatives with regards to cross functional product development, product launches, training and sales support. The successful candidate will build relationships with cross functional team members, sales management, sales representatives and surgeons and add value beyond transactional tasks by pursuing creative and innovative opportunities to provide timely, meaningful, market research, product collateral and training materials. Excellent interpersonal and leadership skills along with one year or more of related experience and a Bachelor's degree or Master’s degree are essential for this position. etc.

To provide administrative and on-site support to the exhibits department, focusing on international logistics and execution. Assist with all pre-planning, onsite and post events tasks. Serve as a liaison to internal and external clients, including employees, vendors and associations. Essential Duties and Responsibilities: Correspond with exhibitor appointed contractors and association meeting organizers on international exhibit requests as needed. Work with marketing project manager on project requests related to international exhibits activities, and assist & update marketing on changes and deadlines. Work with the AXIS project team and Exhibit Data Specialist on details required for of the leads app and list management. Post show download leads generated, run through the Denied Parties List for GTO and distribute to global team members. Coordinate with global partners to collect user data, conference details and focus products to update the AXIS lead system. etc.

Support the laboratory workflow in an efficient and effective manner. Support Analytical group in maintaining the laboratory to make work flow more efficient. Essential Job Functions/Responsibilities: Responsible for promoting and maintaining safe and healthy working conditions in his / her assigned work area; instructs and enforces compliance with established safe work practices and procedures; ensures assigned trainees receive appropriate training and information necessary to conduct their activities in a safe and healthy manner. Properly disposes of solvent waste in appropriate containers and disposes of empty bottles in the recycling bins according to health, safety and environmental practices. Performs laboratory, office and maintenance on a routine basis. etc.

Atreca's IRC technology identifies anti-tumor human antibodies in a highly accurate and precise fashion. Our goal is to apply this technology to elucidate and characterize novel tumor targets and associated biologic processes that were selected for attack by the patient's immune system. In this position, the successful candidate will apply their skills and expertise in protein biochemistry to further understand the unique biology associated with our targets and contribute to the clinical application of our antibodies using protein biochemistry and molecular biology techniques. The candidate will have extensive experience in molecular biology and protein biochemistry as related to the identification and characterization of proteins driving tumorigenesis. etc.

The Clinical Trials Assistant is responsible for supporting the organization to successfully develop and implement clinical trials across its product portfolio and development pipeline. 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. etc.

The Building Services Technician supports the Facilities, Maintenance, and other teams as needed to ensure manufacturing is performed according to schedule and quality demands. Job responsibilities include, but are not limited to, basic maintenance tasks for facilities and equipment, etc. Your Tasks: Follow Standard Operating Procedures (SOPs) and approved directions to perform basic maintenance tasks on facilities and equipment. Follow SOPs and approved directions to clean glassware and equipment used in GMP processes. Maintain cleaning logs and maintenance logs. Maintain stock of parts, supplies, materials, and tools within areas of responsibility. etc.

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. This exciting role also provides excellent growth and advancement opportunities along with a bonus incentive program. etc.

Cleans, sanitizes and monitors equipment related to assembly, machinery, processing and/or packaging for all local manufacturing operations. Sets up and operates automatic or semiautomatic machines and related equipment in a continuous production/processing operation. Monitors meters, gauges, valves, flow ratios, temperatures, pressures, and/or related controls and guidelines to ensure adherence to production/process specifications. Responsible for executing all processes in production while strictly adhering to cGMP, SOPs, environmental health and safety guidelines and any other related regulations which could apply. Reports any malfunctions or abnormalities and performs all work in accordance with established safety procedures. etc.

The Regulatory Operations Associate supports the regulatory submission process by managing archiving of submission documents both in paper and electronic format, correspondence and communications, data management, and process evaluation and control. All in compliance with applicable regulations, standards, and internal policies and procedures. This position responsible for maintaining the regulatory archive. Essential Functions of the job: Archiving: Manage and maintain submissions and correspondence in the regulatory archive system. Coordinate exchange of records using document sharing platforms. Generate metrics, reports, and dashboards. Reconcile data o Archives/retrieves regulatory documents (both paper and electronic) as necessary. etc.

Under direct supervision, perform installation and wiring of electrical components on company produced equipment. Read and interpret basic wiring diagrams, specifications, and work orders to determine materials requirements or assembly instructions. Assemble basic electrical or electronic systems or support structures and install components, units, sub-assemblies, wiring, or assembly casings using rivets, bolts, and soldering equipment.

Interacting with project team, client, and vendors designing and specifying production line and facility layouts. Working directly with vendors specifying equipment. As-building facilities

The Controls/Automation Engineer will design, program, and troubleshoot packaging machinery and line control systems. This person will travel to top clients across the country to assist in the design of manufacturing processes, help manage projects, develop facilities, and impact the world by conducting themselves with integrity in pursuit of individual and enterprise goals. Create user applications to monitor and control the production of consumer goods, to satisfy various regulatory agencies, using modern industry standards

The Research Associate located in Lexington, MA USA will be primarily responsible for developing and executing immune-oncology in vitro and ex vivo assays of Bicycle® T-cell modulators to enhance progress of Bicycle’s oncology pipeline towards the clinic. In this lab-based role, he or she will be a key player in implementing in vitro characterization of lead T-cell modulator series. Key Responsibilities: The successful 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. etc.

We are looking for an outstanding Research Associate to work in our Immunology Cell & Gene Therapy R&D group.  This position will provide technical and logistical support for our R&D team with an emphasis on performing immunoassays to support our QuickGelTM  related products. Use flow cytometry to perform experimental and quality control assays for characterization of products. Perform product development-related experiments under general supervision.

Primary Responsibilities: Communicates with Clinical Project Managers, Clinical Operations Associates and/or Specialists regarding image quality, deliverables, and data discrepancies. Communicates with Image Analysis Lead, Clinical Operations Manager, and/or Scientific Director regarding troubleshooting of reading systems, image quality concerns, and deliverables. Maintains study-specific reading tracking tools. Attends all central analysis and quality control training sessions. Completes validation of relevant central analysis types by meeting pre-defined validation requirements. Performs quality control of site qualification- scans using phantom or patient, and on-going patient data within study-specific turnaround times to Clinical Project Manager, Clinical Operations Associate, and/or Specialist responsible for the study. etc.

Billing Specialist I will be responsible for obtaining necessary patient information to submit on medical claims sent to insurance plans. They will make phone calls to insurance plans and facilities, accurately record information obtained in patient files, and submit claims and appeals to insurance on behalf of patients. Billing Specialist I will work closely with Customer Support Patient Advocates and Billing Team to ensure accurate information is recorded and billing concerns are addressed. etc.

BioFire Diagnostics, LLC. is looking for an ETL Developer I to join our growing team! The ETL Developer will analyze, design, develop, test and maintain the data pipeline component of BioFire’s Data Warehouse. This includes refinement of stored procedures to improve daily and real-time data loads in effort to make them more efficient and scalable. ETL Developer will work closely with BI Analysts and Engineers to build a Data Warehouse that provides quality, accurate, accessible and governed data capable to deliver business insight to various BioFire business domains through reporting, dashboards and visualizations. ETL Developer will promote Kimball methodology and utilize current technology stack to find innovative solutions to complex data problems. Ability to work as a team player alongside a talented group of individuals for the same cause is essential to success in the role. etc.

BioFire Diagnostics, LLC. is looking for a Manufacturing Engineering Technician Trainee to join our growing team! This engineering technician works within a manufacturing engineering team under the leadership of a more experienced individual. This engineering technician uses experience and education to perform the types of technician activities which are within the realm of manufacturing engineering technician and This engineering technician is expected to work and communicate well with other team members and leadership as assigned in order to meet the goals of the project, the department, and the company. etc.

Job Description: Perform daily health observations and effectively record and communicate abnormalities to the scientists. Perform husbandry duties for rats and mice. Perform daily census, handle related documentation and follow reporting procedures. Perform animal receipt and housing of animals. Utilize internal databases to perform the receipt of animals and processing of supplies. etc.

Engineer I position within the Gene Therapy BioProcess Development Pilot Facility. Candidate must be motivated and innovative with exceptional analytical and communication skills. Essential Responsibilities: 1) Assist with scale up design and execute laboratory experiments with minimal guidance. 2) Perform independent data recording, analysis, and troubleshooting. 3) Establish manufacturable large-scale cell culture operations. 4) Document development work in concise reports and provide project updates in written and oral presentations. etc.

This position will focus on development of high productivity and robust cell culture processes through classically and statistically designed experiments. The candidate’s goals will be to increase process robustness and productivity through comprehensive understanding of levers important to mammalian cell culture. A major component of the role will involve conducting and documenting laboratory bioreactor experiments with a focus on process definition and understanding, experimental design and troubleshooting, and data analysis. etc.

BioLegend develops world-class, cutting-edge antibodies and reagents for biomedical research, manufactured in our state-of-the-art facility in San Diego, CA. Our mission is to accelerate research and discovery by providing the highest quality products at an outstanding value, along with superior customer service and technical support. Our product expertise covers a diverse set of research areas including Immunology, Neuroscience, Cancer, Stem cells, and Cell Biology. The Manufacturing Support Technician position will be a key member of our Manufacturing team and will work closely with the BV Conjugation group to assist with the smooth operation of the BV Conjugation laboratory. etc.

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. etc.

BioLegend has an opening for a Manufacturing Associate in our Chemistry group for our MojoSort Product Development team. The main responsibility for this position will be to assist in the large-scale manufacturing of magnetic nanoparticles conjugated with proteins such as streptavidin and antibodies according to established Standard Operating Procedures (SOPs). Other duties will include completion of appropriate batch record forms and updating relevant databases. etc.

Albuquerque based advanced thermal shipping solution manufacturer is looking to hire a full-time Quality Control Technician with starting pay depending on experience. SAVSU Technologies builds integrated, innovative hardware and software solutions designed to protect live cell therapies during transport and storage. Our customers include cell and gene therapy companies, specialty couriers, biotech/biopharma, research institutions, governments, and NGOs. Quality Control Technician at SAVSU Technologies is responsible for maintaining and improving the existing quality management system alongside the Quality Assurance team. etc.

The Manufacturing Technician is responsible for supporting and performing routine procedures associated with the manufacture of the customer’s product with minimal direction from Supervisor. Manufacturing Technicians responsibilities include performing environmental monitoring, cleaning and sterilizing of glassware, cleaning of clean-room suites, manufacturing preparatory activities and clean-up, assist in formulation, visual inspections, labeling and packaging. They may be aseptically qualified to perform aseptic manufacturing set-up, filtration, filling and closure of product. etc.

The Associate Sales Representative (ASR) plays a critical role in helping to improve people’s lives every day, interacting directly with healthcare providers and their patients to introduce our products. ASRs also educate patients on the proper use of our products and provide invaluable support to the entire sales team. Ideal candidates have strong interpersonal skills and determination to provide the best possible experience to our customers and coworkers. They strive for excellent performance, driven by the willingness to both teach and learn. etc.

The Associate Sales Representative (ASR) plays a critical role in helping to improve people’s lives every day, interacting directly with healthcare providers and their patients to introduce our products. ASRs also educate patients on the proper use of our products and provide invaluable support to the entire sales team. Ideal candidates have strong interpersonal skills and determination to provide the best possible experience to our customers and coworkers. They strive for excellent performance, driven by the willingness to both teach and learn. etc.

BioVision, Inc., a privately held Life Science company, develops and offers world-wide, a variety of products including assay kits, antibodies, recombinant proteins & enzymes, and other innovative research tools for studying Apoptosis, Metabolism, Cell Proliferation, Cellular Stress, Cell Damage and Repair, Diabetes, Obesity and Metabolic Syndrome, Stem Cell Biology, Gene Regulation, Signal Transduction, etc. We are looking for a highly motivated individual to work in our Sales & Marketing Department. 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. Primary Duties and Responsibilities: Prepares and analyzes products to determine chemical and physical properties. Documents work in a clear and organized manner. Follows all safety rules and regulations and conducts periodic safety audits. etc.

Our Lab Techs are: Quality driven processers. When our customers send us samples for sequencing, they help to prepare and process these samples as quickly and as awesomely as possible, while maintaining the highest quality standards in the industry. They prepare DNA templates which include preparation, amplification and PCR purification and load these samples onto the sequencers. They also work to prepare buffers and other related solutions. etc.

Responsibilities: Verifies and keeps records on incoming and outgoing shipments and prepares items for shipment. Provide Quality Assurance checks prior to packaging instruments: configuration confirmation and labeling. Cleans, labels, and packages instruments into customer facing final package. Confirms packaged items to ‘pick list’. Determines method of shipment, utilizing knowledge of shipping procedures, routes and rates under direction of Shipping Department lead. Affix shipping labels on packed cartons. Assembles cardboard containers. Inserts items into containers, using spacers, fillers and protective padding. 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.

This role will also work to develop a thorough understanding of the techniques, processes, and applications of technical knowledge to implement a process suitable for manufacturing of both drug substance (DS) and drug product (DP). A scientist in analytical development will be responsible for developing and executing analytical methods (ELISA, HPLC, Mass Spectrometry, Spectroscopic, Biophysical, etc.) for supporting process development activities. 

Quality Associate I (QA Operations) is responsible to provide Quality Assurance support real-time for GMP Manufacturing of master/working cell banks, biological bulk drug substance and finished drug product to be used for human consumption. Responsibilities include providing QA on the Floor oversight of manufacturing including observing critical processes and performing AQL visual inspection, executed GMP documentation review and supporting other QA functions as needed. Continuously monitor systems and procedures to ensure compliance with applicable regulatory and industry standards, quality improvements, and efficiency for phase appropriate GMP manufacture of biological products.      Quality Associate I (QA Operations) is responsible to provide Quality Assurance support real-time for GMP Manufacturing of master/working cell banks, biological bulk drug substance and finished drug product to be used for human consumption. Responsibilities include providing QA on the Floor oversight of manufacturing including observing critical processes and performing AQL visual inspection, executed GMP documentation review and supporting other QA functions as needed. Continuously monitor systems and procedures to ensure compliance with applicable regulatory and industry standards, quality improvements, and efficiency for phase appropriate GMP manufacture of biological products.      

In support of large molecule therapeutics, execute laboratory work plan / schedule developed with input from supervisor or senior team member. Sample types include in-process, release or stability. Analytical techniques may include any or all of the following: HPLC/UPLC techniques/methods (e.g. SEC, IEX, RP-HPLC, HIC, peptide map, glycan analysis, etc.). Karl Fischer, Compendia assays, (i.e. appearance pH, etc.). UV-Vis, Solo-VPE, Nano Drop

The Manufacturing Associate I performs and documents cGMP activities to support upstream or downstream production areas and operations. This involves operation of process equipment, execution of validation protocols, completion of cGMP documents, creating/ revising cGMP documents and other assignments as directed. The Manufacturing Associate I performs and documents cGMP activities to support upstream or downstream production areas and operations. This involves operation of process equipment, execution of validation protocols, completion of cGMP documents, creating/ revising cGMP documents and other assignments as directed.

The Support Technician contributes to the manufacturing team effort by accomplishing related tasks and assignments. The Manufacturing Support Technician reports directly to Supervisor of Manufacturing. Responsibilities include, but are not limited to: Use of the autoclave, depyrogenation oven and sonicator. Clean Formulation and Fill Vessels. Gowning for classified areas. Stock and stage processing areas. Other duties as assigned. etc.

The Associate will support Facilities compliance by overseeing GxP documentation including creation and revision of Standard Operating Practices (SOPs) and associated Work Instructions (WIN). The Associate will be responsible in performing F&E related deviation investigations and CAPA. DUTIES AND RESPONSIBILITIES: Key Responsibilities: Responsible for adherence to all Operating Procedures, protocols, policies, regulatory requirements, GMP, and safety guidelines. Responsible for maintaining all required records and adherence to established guidelines for quality control procedures, GMP’s, and safety. Participate in the development and revisions to the Facilities & Engineering training program. etc.

BMS company is seeking enthusiastic, self-driven individuals to join its innovation-focused, multi-disciplinary team focused on advancing new, enabling technologies. This development role will be part of a team of associates, engineers, and scientists that develop next-generation processes and technologies for manufacturing adoptive T-cell therapies. The positions will require experimental design, experimental execution, data analysis, drafting of technical reports, and presentation of results. etc.

We are seeking a highly capable and enthusiastic Associate Scientist to work with a multidisciplinary group of engineers and scientists to support the development of novel Process Analytical Technologies (PAT). The Associate Scientist will be responsible for independently executing microscopy-based and cell selection experimentation. The candidate will additionally be expected to execute T cell culture experiments using a combination of scale-down models and manufacturing scale bioreactors. The successful candidate will: Work within a multi-disciplinary environment towards novel applications of Process Analytical Technologies. Independently design experiments, analyze data and draft technical reports to communicate key conclusions. Independently execute multi-parametric cell sorting and flow cytometry experiments. etc.

We are seeking a highly organized and enthusiastic Research Associate to join our Conjugation team. The successful candiate will assist the team with releasing new products, supporting existing products and providing technical support for all conjugated antibody product lines. Responsibilities: Performs experiments focused on conjugation including dye conjugation, bead conjugation, HRP conjugation, biotin conjugation, PE conjugation and PE tandem dyes for the purpose of enabling the release of direct conjugated antibody products and maintain existing product lines. Performs protein purification and determination. etc.

We are seeking a Laboratory Assistant for our Contract Research Laboratory who will perform immunology testing of client specimens collected from both pre-clinical and clinical studies using the following test methods: ELISPOT, ELISA, flow cytometry, etc. You will help support our quality improvement projects in conjunction with QA, support our quality system by data quality control, communicate with fellow laboratory personnel, maintain laboratory equipment, write reports, etc. All work is performed according to general laboratory safety standards, internal standard operating procedures (SOPs), client protocols, and applicable international, federal and state regulations.

MVL is seeking Laboratory Technician 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 technician 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. etc.

The Environmental Monitoring Technician I will perform microbiological testing involving environmental monitoring, water, and other production utilities to help ensure quality production. The technician will ensure products are tested in a manner consistent with Standard Operating Procedures and in compliance with regulations according to 9CFR. Responsibilities and Key Duties: Perform routine daily, weekly and monthly environmental monitoring testing on processes, utilities, and personnel. Sample purified water system, clean steam, and other utilities for subsequent analysis. Perform assigned sampling tasks carefully and on schedule according to standard operating procedure and supervisor instruction. etc.

PRIMARY OBJECTIVES: Support in vivo oncology studies in mice as a member of the Veterinary Services Team. DUTIES AND RESPONSIBILITIES: Conduct daily and weekly assessments and treatments of animals identified with abnormalities. Support the training program by conducting didactic and hands on training courses. Administer the health surveillance program as described, including animal and sample submission and tracking of results. Proficiently perform survival animal surgeries and provide perioperative care. etc.

We are seeking a Research Technician for our Pharmacokinetics and Acute Toxicology Team at our Safety Assessment site located Mattawan, MI. A Research Technician is responsible for: administering substances to animals, performing husbandry duties, including cleaning/transporting caging and providing food and water; performing clinical observations of animals to determine morbidity/mortality; collecting and handling data and specimens; euthanizing animals and assisting veterinarians, management, and other company personnel with animal care, study-related tasks, and process improvement initiatives. Please Note: we are seeking Talent for both 1st and 2nd Shift positions, as well as standard and alternate work schedules (e.g., M-F, Tu-Sat) The following are minimum qualifications related to the Research Technician position: HS/GED or Bachelor’s/Master’s with no relevant experience. etc.

We are seeking a Research Technician for our Developmental and Reproductive Toxicology Team (for both In-Life and the Teratology Laboratory) at our Safety Assessment site located Mattawan, MI. A Research Technician is responsible for: administering substances to animals, performing husbandry duties, including cleaning/transporting caging and providing food and water; performing clinical observations of animals to determine morbidity/mortality; collecting and handling data and specimens; euthanizing animals and assisting veterinarians, management, and other company personnel with animal care, study-related tasks, and process improvement initiatives. Please Note: we are seeking Talent for both 1st and 2nd Shift positions, as well as standard and alternate work schedules (e.g., M-F, Tu-Sat). etc.

We are seeking an experienced Animal Care Technician I for our Safety Assessment site located in Shrewsbury, MA. Responsible for performing operational, administrative and technical tasks to provide comprehensive care for all species of laboratory animals at the site, including: daily health observations, feeding/watering, sanitizing primary and secondary enclosures, environmental enrichment, handling and restraint and related tasks. Assist with the movement of animals and stocking of supplies. May serve as lead/primary technician and perform technical duties with guidance.

This position is responsible for performing Quality inspections of routine processes in the Manufacturing department. These inspections may occur in aseptic production rooms. The Auditor I will also be responsible for a Quality review of basic records and reports in support of the Manufacturing department to assure compliance with applicable regulatory requirements, international standards, and corporate policies and procedures. We are seeking a Quality Assurance Auditor I for our Biologics Testing Solutions site located in Malvern, PA. The following are responsibilities related to the Quality Assurance Auditor I position. Assure Charles River’s compliance with applicable federal, state, and local regulations as well as corporate policies to avoid any business interruptions. Communicate all identified compliance and quality risk to supervisor. etc.

The successful candidate will be an experienced chemist with state of the art knowledge of synthetic organic chemistry and will be a motivated, creative, hands-on laboratory scientist with the ability to interact effectively with team members and external customers. Major responsibilities will involve design, synthesis, purification, and characterization of novel chemical entities and the management of general chemistry lab operations under the direction of senior scientific staff. The qualified individual is expected to contribute to process development and scale-up of key intermediates.

The Process Development Associate will be responsible for the development, optimization, and scale-up of protein purification processes. The ideal candidate will have experience with the optimization of enzyme recovery/purification processes. Responsibilities Include: Perform protein recovery experiments using unit operations such as homogenization, centrifugation, depth filtration, microfiltration, and ultrafiltration. Perform resin screening, column chromatography (IEX, HIC, MMC, CHT etc.). Analyze processing samples, using biological, biochemical, and other relevant analytical methods. Communicate results of experiments to the Project team. Participate in daily operation and routine maintenance/housekeeping of process and analytical equipment. etc.

The CAD Engineer I will be responsible for designing and reviewing patient-specific implants and surgical instruments using various software packages while ensuring Conformis quality standards. Essential Duties and Responsibilities: Develop and maintain strong internal working relationships across Conformis. Understand the objectives, responsibilities, and mission of the CAD department and works towards those goals. Prioritize and plan work activities; adapt for changing conditions. Generate 3D models from diagnostic CT images and use commercial and research software to design patient specific implants and surgical instruments. Work independently to achieve departmental and personal goals. Plan and manage workload effectively and efficiently. etc.

Design and conduct routine laboratory analysis using various analytical instruments and software such as HPLC, UPLC, ICP, and UV-Vis. Responsibilities: Responsibilities include, but are not limited to: Knowledge of USP and FDA requirements. Design and conduct full analysis of Dietary Supplements and Active Pharmaceutical Ingredients (API) products and their impurities. Conduct assay, content uniformity, dissolution, in-process blend, and blend uniformity of newly developed and stability samples in support of formulation and process development. Prepare result documentation for department and general review. etc.

A Chemist Level I is responsible for performing chemical testing and completion of real-time documentation per cGMPs and current SOPs. Essential Job Functions: Perform UPLC, HPLC, GC, UV-vis, FTIR, ICP, TOC and wet chemistry testing. Proficient in various UPLC and HPLC software programs, such as Empower and EZ-Chrom. Assist in writing SOPs and Test Procedures following good documentation practice per company's SOP and cGMP regulations. Assist in OOS investigations. etc.

Covance is seeking candidates for an Associate I Regulatory Submissions. The Associate I Regulatory Submissions is an office based role in Princeton, NJ. Assist in the preparation of submissions filed to Regulatory Authorities (e.g.: INDs, CTAs, NDAs, NDSs, MAAs or CTDs). Contribute to the preparation of submissions to Regulatory Authorities by reviewing/summarizing scientific/research documents. Assist in the coordination, collection and organization of information required by Regulatory Authorities. Interact with the Publishing group, Copy Center or equivalent as necessary for the production of submissions. etc.

Purchasing: Process purchase and material requisitions for the Facility Management Department. Coordinate and expedite stock and non-stock material requisitions for maintenance repair. Work closely with Facilities planners/schedulers, maintenance supervisors, and crafts persons to coordinate delivery schedules, provide purchase order information and resolve invoice discrepancies. Perform RCP duties as delegated. etc.

Job Summary: Support CMC Analytical activities for Crispr clinical programs by reviewing batch records, assay results. Perform Data Review for integrity and accuracy and collate data in a highly organized manner. Use statistical software to analyze the data for shelf life trending and control chart trending. Monitor stability program for time pulling of the samples, scheduling and following the results with the testing labs. This is a Cross-functional and highly visible position within Technical Operations group. The position requires active collaboration with research, process development and quality teams and CDMOs. etc.

We are seeking a qualified individuals to join us as Quality Control Chemists at our Menlo Park facility. This position will be responsible for conducting QC testing for release, stability, and raw materials, as well as executing experiments in support of routine QC testing utilizing various analytical techniques. Core duties and responsibilities include the following: Conduct sample analysis using various analytical techniques, including HPLC, UPLC, GC, KF, FT-IR, TLC, and LC-MS, GC-MS. Preparation of laboratory reagents and samples; operation of instruments; data analysis; preparation of analytical reports; notebook documentation. etc.

Responsible for the accurate and timely sampling, testing, shipping and storage of plasma collected from donors. 1 In compliance with Standard Operating Procedures (SOPs), responsible for collecting plasma samples and moving plasma units to freezer to ensure product quality. 2 Ensures plasma units are properly stored according to SOPs, which could include unsuitable plasma units and samples. 3 May ensure accuracy of unit labeling by verifying the pre-printed label matches the dynamic label. 4 Utilizes sterile technique to draw samples and uses heat sealer to assure the sterility and quality of plasma unit samples per SOPs. etc.

What You'll Do: Assist with Interfacing between sponsors, vendors, and other departments in the area of safety and pharmacovigilance. Includes assisting with development of project-specific process documents such as Safety Management Plans, Project-Specific Operating Procedures (PSOPS), and/or guidelines as agreed to by CTI and sponsors. Process serious adverse events (SAEs) according to Standard Operating Procedures (SOPs) and project specific safety plans. Triage SAEs, evaluates SAE data for completeness, and regulatory reportability. Enter relevant safety data into safety database. Perform coding of SAEs, medical history, concomitant medications and diagnostic tests. etc.

What You'll Do: Assist with Interfacing between sponsors, vendors, and other departments in the area of safety and pharmacovigilance. Includes assisting with development of project-specific process documents such as Safety Management Plans, Project-Specific Operating Procedures (PSOPS), and/or guidelines as agreed to by CTI and sponsors. Process serious adverse events (SAEs) according to Standard Operating Procedures (SOPs) and project specific safety plans. Triage SAEs, evaluates SAE data for completeness, and regulatory reportability. Enter relevant safety data into safety database. Perform coding of SAEs, medical history, concomitant medications and diagnostic tests. etc.

What You'll Do: Assist with Interfacing between sponsors, vendors, and other departments in the area of safety and pharmacovigilance. Includes assisting with development of project-specific process documents such as Safety Management Plans, Project-Specific Operating Procedures (PSOPS), and/or guidelines as agreed to by CTI and sponsors. Process serious adverse events (SAEs) according to Standard Operating Procedures (SOPs) and project specific safety plans. Triage SAEs, evaluates SAE data for completeness, and regulatory reportability. Enter relevant safety data into safety database. Perform coding of SAEs, medical history, concomitant medications and diagnostic tests. etc.

We are experiencing exponential growth on a global scale and hiring Financial Analyst to join our Finance division. Summary of Job Responsibilities: As the Finance Analyst supporting Project Leadership Team, you acquire an understanding of the project economics and profitability drivers. Under supervision, you will assist in translating them into operational actions, and proactively advising the PL on how to influence critical operational levers in order to positively impact project financials. Key Responsibilities include: Create accurate, transparent, and timely financial analysis to support project leadership in project decision making process; etc.

The Facilities Technician is integral to successful biologics manufacturing and to product safety. The Facilities technician maintains, calibrates, and operates equipment and utilities in an FDA-regulated environment. This is an entry level position, On the Job training will be provided. ESSENTIAL DUTIES AND RESPONSIBILITIES: Completes all scheduled maintenance and calibration activities on time. Each month, evaluates assigned workload and manages time to complete the work (ex. ordering/gathering supplies, coordinating with other departments for equipment availability, etc.). Ensures documentation of all activities is completed in compliance with company procedures. etc.

This position is accountable for producing and delivering large and small-scale media and buffers to support Upstream and Downstream Manufacturing Operations. ESSENTIAL DUTIES AND RESPONSIBILITIES: Batching and delivering both large and small-scale media and buffer batches. Assisting in the review & creation of operation documents by providing input to technical composition of documents. Effectively demonstrate understanding of GMPs & how it applies to specific responsibilities. Following accurate oral & written procedures in operating production equipment & performing processing steps. Maintain orderliness of process area. etc.

Demetrix is a start up in the San Francisco Bay area that is making nature’s medicines in a smart and responsible way. We are seeking an Associate Scientist/Senior Associate Scientist to assist the Strain Engineering team. The individual in this role will be part of an interdisciplinary team of molecular biologists, fermentation scientists and engineers, automation engineers, software engineers, and analytical chemists working to rapidly develop microbial strains to produce natural product medicines. etc.

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. Essential Duties and Responsibilities: Perform extraction techniques involving DNA/RNA, PCR and RT-PCR reactions, qPCR and RNA/DNA sequencing. Identify problems that may affect test performance or results and, following established protocols, correct problems or escalate to Clinical Laboratory Manager, technical supervisor, clinical consultant or lab director. etc.

The PET CT technologist operates diagnostic imaging equipment to produce images that assist physicians in the treatment and diagnosis of our patients. Essential Functions: 1. The technologist demonstrates the knowledge, skills and abilities to perform imaging procedures that meet the quality expectations of the patient, referring physician, and radiologist. 2. Following orders of the referring physician and protocols specified by Radiologist. 3. Administers medications such as contrast media, FDG, radiopharmaceuticals as prescribed by the physician order. etc.The PET CT technologist operates diagnostic imaging equipment to produce images that assist physicians in the treatment and diagnosis of our patients. Essential Functions: 1. The technologist demonstrates the knowledge, skills and abilities to perform imaging procedures that meet the quality expectations of the patient, referring physician, and radiologist. 2. Following orders of the referring physician and protocols specified by Radiologist. 3. Administers medications such as contrast media, FDG, radiopharmaceuticals as prescribed by the physician order. etc.The PET CT technologist operates diagnostic imaging equipment to produce images that assist physicians in the treatment and diagnosis of our patients. Essential Functions: 1. The technologist demonstrates the knowledge, skills and abilities to perform imaging procedures that meet the quality expectations of the patient, referring physician, and radiologist. 2. Following orders of the referring physician and protocols specified by Radiologist. 3. Administers medications such as contrast media, FDG, radiopharmaceuticals as prescribed by the physician order. etc.

The Technologist Assistant supports the technologist with various duties including transporting patients between the facility and scanner and completing paperwork. Essential Functions: 1. Assisting the technologist with patient care by transporting patients between the facility and scanner; sanitizing and cleaning patient care and staff areas; changing table linens; entering exam and patient information electronically or on paper; and answering the telephone. 2. Demonstrates the knowledge and skills necessary to provide care appropriate to the age of the patients served. 3. Demonstrates knowledge and skills necessary to provide care appropriate to the age of the patients served. etc.

DiscGenics is seeking an independently-driven quality engineer capable of implementing Quality Management System (QMS) processes in accordance with applicable country regulations and standards for biologics, pharmaceuticals, and medical devices. The quality engineer will also support new product development efforts including design control and risk management. Responsibilities: Serves as the voice of quality during the product design and development process. Facilitates risk assessment activities. Defines and implements the Quality Management System processes in accordance with 21 CFR 210/211, 21 CFR 820, 21 CFR 1271, including CAPA, training, internal audits, supplier controls, etc. etc.

DiscGenics is a clinical stage biotechnology company performing studies to support the continued development of our cell therapy products to treat diseases of the spine. We are seeking a laboratory associate who can support the analytical team in developing, qualifying and performing a variety of cellular and chemical test methods. This is an entry level laboratory position that will provide experience with cell culture and cell characterization methods. The ideal candidate will be hard working and enthusiastic about our mission to aid patients with disc degeneration and have some experience with cell culture, cell based assays and/or laboratory automation. etc.

DDC is growing rapidly, and our customers need fast and accurate solutions for their life-changing challenges and questions related to paternity or other family relationships. The role of the Sales Representative (Direct to Consumer) is DDC’s premier sales position. From 8am to 8pm Monday through Friday, our global customers call us for answers about relationships that they use for immigration, surrogacy, or simply confirming the father of a child. The successful candidate for this role determines the services our clients require, charts their course through the testing process, and closes the sale. Income is not capped, and six-figure upside is achievable—it is determined by your own skills and motivation. etc.

To conduct manufacturing and polymer development tasks. MAIN DUTIES AND RESPONSIBILITIES: Perform manufacturing/synthesis under GMP. Clean GMP equipment. Assist in polymer manufacturing equipment calibration and maintenance. Assist in equipment qualification studies, including documentation of studies. Assist in performance of R&D development programs. etc.

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 position of Scientist I/II, Assay Development is part of the PD Analytics team and will assist the Process Development group in developing novel assays and supporting existing analytical assays used to characterize gene therapy products and processes in our pipeline. An ideal candidate will have experience in a drug development environment, analytics for viruses and viral vectors and well-versed in assay development and qualification. etc.

As a key member of the fermentation department the fermentation technician is responsible for the growth of bacteria used to create vaccines based on proprietary SRP technology. This critical role will be engaged in production, process improvement, and the support functions necessary to ensure vaccine delivery to hundreds of customers throughout North America and the world. SRP technology is critical to the maintenance of the global food supply and the fermentation technician is truly in on the ground floor. etc.

Employee Responsibilities: Ensures that our clients receive quality data by reviewing laboratory data for accuracy, clarity, and adherence to GMP and/or GLP regulations. The Ideal Candidate would possess: Strong computer, scientific, and organizational skill. Excellent communication (oral and written) and attention to detail. Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude. Ability to learn new procedures, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies.

The team seeks a scientist that is a highly motivated individual to performing a range of in vitro ADME assays (ex: solubility, microsomal stability, PPB, Cyp inhibition, Permeability) and PK studies to support the discovery and development of small molecule and peptide therapeutics. In this lab-based position, the qualified candidate will work closely with our established team to develop and conduct ADME assays to address ADME questions and support projects. The successful candidate would have the opportunity to interact with multidisciplinary project teams.

The candidate will join a cross-functional team responsible for profiling and production of recombinant proteins and assay ready cells for assays and biophysics. The applicant will be part of a team of up to 25 people in cell sciences, recombinant protein expression and purification from eukaryotic and prokaryotic hosts. Candidates will be responsible for the production, purification and/or characterization of a range of protein targets within the pharmaceutical arena. etc.

Duties and Responsibilities (Key Deliverables): 1. Process loaner/instrument returns: sterilization, cleaning, completing required forms, updating the inventory control system, performing functional checks, and restocking. Initiate the processing of those instruments that do not satisfy the quality standards (Non-Conforming instruments). Refer complaints of service or product failure to appropriate departments. 2. Perform minor repairs on instruments and provide disposition of obsolete or worn instrumentation in accordance with established procedures. 3. Stock instrument storage bins. 4. Assist in the filling of orders. 5. Provide on call services as necessary. etc.

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). Will be working 20 – 24 hours a week. etc.

Fate Therapeutics is seeking a motivated professional with analytical assays experience to support Fate’s clinical and manufacturing process development programs. The successful candidate will execute and analyze experiments to assess the characteristics of hematopoietic and stem cell-based therapeutics under cGMP environment. Candidates must have experience working with mammalian cell culture, and analysis of data from flow cytometry, cell-based assays, or PCR assays. This is a full-time position located at our corporate headquarters in San Diego, California reporting to the Senior Manager, QC. etc.

Mechanically and electrically troubleshoot, inspect, and test valves at specified job worksites. Primary worksites include FCX valve repair centers with occasional customer in-field work sites. Perform pre-testing, disassembly, cleaning, in process inspection, machining, lapping, painting, assembly, testing, and final inspection on various types of valves and actuation. Repair relief valves, control valves, on/off valves and pneumatic actuators in FCX actuation facility or customer plant locations.

Considering a new job and company is a really big decision. Typical job descriptions don't really give you a sense of what a job is actually like. When considering a Flex Sales role at Flexion, we want you to see why this opportunity is so amazing, the impact you'll have and what the company and culture are really like. Why this role is different: First, let's talk why this role is different from other sales roles and what you'll get to do: The name says it all. Flex means it's a mix of inside sales and in person sales. This role is a fantastic way for driven, passionate and resilient individuals earlier in their career to gain experience. You'll manage daily sales call activity, with the purpose of influencing customers and increasing sales. etc.

Fluidigm is seeking a Reagent Manufacturing Associate. The Reagent Manufacturing Associate is a member of our Proteomics Reagent Operations team. The scientist will be accountable for QC testing of raw materials, in-process materials and finished goods for release. This individual will also be a subject matter expert in the development and testing of new QC procedures. etc.

Your tasks: Hand assemble manufactured medical components. Complete required documentation for work performed. Quality inspect work performed. Follow defined work procedures. Provide your suggestions and ideas of continuous improvements.

Your tasks: Hand assemble manufactured medical components. Complete required documentation for work performed. Quality inspect work performed. Follow defined work procedures. Provide your suggestions and ideas of continuous improvements.

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.

Essential Functions: Assist in the development, optimization, and scale-up of chromatography processes (including affinity, IEX, HIC, etc.) and filtration processes (including UF/DF, depth filtration, and sterile filtration, etc.). Operation of chromatographic systems (GE AKTA, and other Unicorn based equipment). Operation of centrifugation equipment. Operation of filtration equipment. Participate in developing and carrying out experimental protocols. etc.

The Analytical Development group is seeking an energetic Associate Scientist or Scientist I with protein chemistry experience to become an integral member of a high performing method transfer team supporting protocol based activities including technical transfer of methods from donor labs as well as training of colleagues for internal transfer, and qualification, validation and verification of methods. The successful candidate will primarily execute biochemistry based techniques such as UPLC/HPLC (SEC, IEX, RP, glycan, affinity, etc.), capillary electrophoresis (icIEF, CE-SDS), gel electrophoresis, UV, western blot (SDS-Page), plate based assays and spectrophotometry (SoloVPE) for the characterization and testing of recombinant protein pharmaceuticals. etc.

Essential Functions: 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. Manages test samples, reagents and reference standards. etc.

Machine learning approaches are at the core of GenapSys' methods for generating high quality DNA sequencing data. As a machine learning engineer, you will join forces in the development of cutting-edge machine learning methods that solve key problems in the DNA sequencing, base calling, and variant calling processes. You will work closely with a cross-functional team of life scientists, bioengineers, and data scientists to identify areas where machine learning can make a difference, to conceptualize and develop biological datasets using cutting edge, high throughput platforms, and to analyze these data sets using the best machine learning methods, applied at scale.

We are looking for a Research Associate, Development who will help to drive the development of reliable high-quality DNA sequencing products. The ideal candidate for this role will have some hands-on experience working in a development environment, including developing and optimizing reagents for R & D, developing QC methods and setting specification that correlate with performance, and carrying out stability studies. Experience with DNA Sequencing technology or similar instrumentation is a plus. If this opportunity sounds exciting, and you have the desire to redefine the current paradigm of DNA sequencing, please apply. etc.

The Clinical Laboratory Associate (CLA) - Accessioning will assist in building and establishing GRAIL’s Clinical Laboratory, performing specimen testing and supporting the daily operations of the Clinical Laboratory. The focus of the CLA - Accessioning will be on the receipt, triage, accession, and centrifugation of patient samples submitted to the CLIA laboratory for testing. You Will: Assist in pre-analytical testing activities including specimen processing, quality control, preparation and aliquoting of reagents. etc.

GRAIL is seeking a Research Associate for the LabOps Manufacturing Sciences andTechnology team (MSAT), who will be primarily responsible for materials quality control (QC) and associated tasks. The ideal candidate is a detail-oriented, exceptional team player with hands-on laboratory experience. The candidate will be expected to partner with many functions of our organization - Automation, Product Development, LIMS, Quality, and Clinical Lab - to identify systems limitations, implement process improvements, write documentation, and be instrumental in the implementation and operation of an internal QC system. etc.

GreenLight Biosciences is seeking a highly motivated and collaborative Research Associate to join our Crop Protection team. Greenlight is developing cutting edge RNA technologies that address key challenges in global Crop Protection. In this role you will be integrally involved in the discovery and development of novel biopesticides by developing and executing bioassays for crop pests. The ideal candidate will also have molecular entomology skills applicable to RNA interference and gene expression analyses. Strong technical, organizational, and communication skills, as well as the ability to maintain a commitment to excellence and high-quality work in a fast-paced milestone driven company, are essential. etc.

Primary Functions and Duties (actual tasks performed based on task-specific training identified on Job Training Requirements Matrix: At all times follow Standard Operating Procedures, and responsible for remaining current regarding SOP changes. 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. 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. etc.

The Validation Automation Engineer II is a junior level professional who is responsible for using technology to improve and streamline a manufacturing process through automation validation. Depending on their specific assignment, this person provides automation validation support for projects or within a specific area. The Validation Automation Engineer II will also integrate into supporting a large scale project. He/she is recognized as proficient in their field such as specific control systems, instrumentation, process, utilities, or qualification testing. He/she meets customer needs in support of business goals. In addition, the incumbent will collaborate with other automation and validation engineers. etc.

The selected candidate provides analytical testing support for process characterization, developmental stability studies, and release of preclinical or clinical batches for internal research projects. The individual selected for this position will conduct testing of non-routine sample types in support of process development, characterization, and/or validation and compile data for the generation of multi-user interactive analytical databases. The analyst may participate in development, implementation and validation of new analytical techniques. etc.

The Manufacturing Associate will execute activities associated with cell culture manufacturing in a clean room environment. Processes will be focused on viral vector based cancer vaccine products. This role will also need to assist with aseptic filling and buffer prep processes as well as maintain material inventory in labs. etc.

We are looking for a full-time Client Services Associate (CSA). The CSA is responsible for providing exceptional support to Guardant Health customers, the Guardant Health Clinical Laboratory, Sales Representatives, and our billing partners. Responsibilities: CSA is responsible for receiving and responding to all types of communication: phone, email and web inquiries from customers (physician offices, laboratories, and hospitals), sales representatives and patients. Keeping precise and clear documentation of all phone communications and follow up activities. Adhering to Standard Operating Procedures (SOP’s) pertaining to data entry and data verification requirements. Ability to enter and qualify new customer information into Salesforce.com and LIMS. Contact physicians and other medical personnel to obtain missing information required to complete the order entry process.

To enable Guardant Health to lead the disruption of cancer treatments through non-invasive cancer screening, the Technology Development Team is seeking a highly motivated Scientist I - II to help develop, test, and improve sample preparation technologies for rare variant studies with next-generation sequencing. At Guardant, we leverage the most advanced technologies and work with leaders in many different fields to create the most impactful and meaningful technologies for cancer management. etc.

The Lunar Research Team focuses on developing and implementing new technologies to improve early cancer detection. We are seeking a highly motivated Research Associate to be hands on in the lab and assist with the planning, developing and use of new molecular assays. You will handle samples from various sources and work with members within the team as well as interface with multiple teams such as process engineering, Tech Ops, and Bioinformatics. etc.

In this role, you’ll be part of a team that is responsible for automating and scaling complex workflows and implementing processes for a state of the art sequencing lab. You will wear multiple hats and support the development of all parts of a state of the art robotics facility. Your customers will be licensed clinical operators; your goal is to use software and automation to help them focus on extensive screening. The Process Engineer will be involved in all aspects of assay automation development from concept, requirements definition, and manual assay development to adaptation, optimization, troubleshooting and validation. etc.

We are seeking a highly motivated CTA to be responsible for the coordination of activities (primarily administrative tasks) associated with Clinical Trial startup and maintenance 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. Key Responsibilities: Maintain and/or accelerate timelines for achieving clinical operational milestones. File, track and maintain study activity. Manage and ensure the paper and electronic Trial Master File (eTMF) meets FDA/ICH/GCP requirements. Coordinate execution of Non-Disclosure and Confidentiality Agreements (NDAs and CDAs) with study sites. etc.

We are currently seeking a Research Associate to join the New Technologies group at Harpoon. Our growing team is focused on the development of novel, conditionally active biologic prodrugs, including our protease-activated T cell engager platform (ProTriTAC). These prodrugs are designed to be preferentially active in the tumor, and thus, enable the safe targeting of previously intractable therapeutic targets. The successful candidate will be expected to design and execute experiments to help develop new biologic prodrug candidates, work collaboratively in a cross-functional environment, and have a strong desire to learn new techniques and the underlying scientific rationale.

Responsibilities: The Electricromechanical Design Technician: Promotes Helmer values as reflected in personal productivity and quality of work; maintains positive internal/external relationships; seeks & considers diverse perspectives; is committed to individual development and achievement of company goals/objectives. Complies with workplace safety procedures. Assembles and update prototype units for new and existing product including mechanical cabinet, electrical wiring and thermal control system. etc.

The Associate Scientist, MSAT performs process and analytical experimental studies as part of a team that is effectively delivering cell therapy services to clients in accordance with defined scope of work, timelines, and budgets. This includes supporting clients in process development, technology transfer and continuous improvement of our client's novel manufacturing processes. Our goal is to support our clients in developing commercially viable cell therapy products, so that they can become accessible to all. etc.

The role of Analytical Development Research Associate is to aid in developing and refining analytical methods to characterize AAV vector products. The individual in this role will be a highly-skilled, talented and motivated researcher who will focus on the analysis of research/development-grade vector samples using multiple AAV-specific analytical methods. This individual will participate in conducting, optimizing and qualifying molecular and bioanalytical assays such as cell-based infectivity, potency, and immunoassay. We seek candidates with proven ability to work independently after initial training and collaboratively to achieve optimized project plans, with the ultimate goal to deliver products that transform the lives of patients. etc.

ICON is currently hiring Clinical Research Associates with at least 1 year of independent monitoring experience in any therapeutic area! You will be supported with manageable sites & protocols, a strong benefits package that includes a comprehensive health plan, retirement plans, competitive pay, vacation, and eligible for the annual performance bonus. Additionally, we have innovative technology and provide excellent training to ensure better outcomes.

We are looking to hire a Filling Laboratory Technician. This role is responsible for performing tasks and functions associated with the filling of production. In addition, you must perform routine upkeep and maintenance of the lab including recording temperatures, cleaning, and disposal of contaminated waste. If you’ve got the necessary skills and experience to excel in this position, we want to hear from you. Apply today! Responsibilities: As the Filling Laboratory Technician, your responsibility will be to accurately complete paperwork with minimal corrections and timely entry of time and materials into ERP when required. etc.

This position will be 2nd Shift (4PM-2AM) Monday-Thursday. Responsible for pharmaceutical manufacturing in compliance with current Good Manufacturing Practice (cGMP). Responsibilities: Ensures consistent completion of all the planned manufacturing activities assigned to him/herself. Minimize waste of the resources (worktime, materials, and components). Organize workplace to maximize the throughput and minimize risks of errors. Follow well defined procedures closely, with attention to detail. Practice strong aseptic technique. Document activities accurately and clearly as per GDP. Operate manufacturing equipment according to well defined procedures. Daily monitoring of the process. etc.

The Mechanical Designer is a temporary position for a minimum of three months with possibility of extending to six months if needed. The primary responsibility is to provide design and drafting of tools and equipment and their documentation including ECO submission. This position works closely with Engineering, Quality and Manufacturing teams. Major Duties and Responsibilities: Create 3D models and detail drawings by reverse engineering existing tools and fixtures. Work closely with the Engineering and Manufacturing teams to understand design intent and incorporate Geometric Dimensioning and Tolerancing (GD&T). etc.

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. Perform in-process inspections and document results. Assist Scientists in developing and implementing quality systems and related activities.

The primary purpose of this position is to develop competency in and performance basic assembly and/or inspection operations at Integer. The incumbent is expected to follow written procedures to meet production and quality requirements. 1. Adheres to Integer's Values, Behavioral Based Safety process and Integer Associate Quality Policy. 2. Sets up equipment needed for assembly/inspection as per Manufacturing Process Instructions (MPI's) and Quality Work Instructions (QWI's). 3. Understands own tasks and how they relate to others on their team. Works under close Supervision where duties are clearly defined. Will follow Standard Work where applicable.

The primary purpose of this job is to operate and monitor machines routinely used in the production of the organization's product. May be involved in the basic set-up, calibration and maintenance of equipment and/or perform finish operations. Key Accountabilities and Responsibilities: 1. Adheres to Integer Values and all safety and quality requirements. 2. Operates machinery used in the manufacture of products with close supervision. 3. May be involved in the basic set-up and/or calibration of equipment. etc.

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.

The primary purpose of this position is to develop competency in and performance basic assembly and/or inspection operations at Integer. The incumbent is expected to follow written procedures to meet production and quality requirements. Adheres to Integer's Values and all safety, environmental, security and quality requirements including, but not limited to: Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements. etc.

Responsibilities: Load and unload incoming and outgoing materials and products. Move materials to and from loading docks, delivery trucks, storage areas, and manufacturing areas. Identify and label materials, and record their locations in the warehouse and on the shelves to maintain inventory. Prepare prep kits for production and make necessary work orders associated with each prep kit. Move these kits to assigned location. Operate trucks, forklifts, cranes, and other equipment to move freight. Perform and report cycle counts weekly. etc.

We seek an entry level Laboratory Technician to perform vital laboratory tasks to support the continued success of our research teams. The candidate will be part of a lab management team that works in a unified and collaborative manner to ensure the efficient operation of the laboratory. Responsibilities: Coordinate multiple tasks with team members to provide needed supplies. Prepare reagents including buffers, chemicals solutions, complex reaction mixtures and media according to established methods and standard operating procedures (SOP). etc.

Intellia Therapeutics is seeking an individual to work closely with the RNA Chemistry Team responsible for synthetic oligonucleotides. This individual will be involved in a complete production process for the identification, implementation & fulfillment of synthesis, purification and reaction scheme analytical characterization and method development of oligonucleotides. RESPONSIBILITIES: Hands-on position in an oligonucleotide chemistry lab inclusive of operating, maintaining & calibrating synthesis platforms and other scientific equipment. Synthetic oligonucleotide method and process development participation. Perform semi-preparative and analytical HPLC and LC-MS quality control processes. Solid decision-making on product path with the ability to work independently and collaboratively while problem-solving. etc.

Support Quality Engineering department on various tasks used to support production and development of medical products used in the treatment for ear, nose and throat disorders. DUTIES AND RESPONSIBILITIES: Work with QE and ME in developing procedures, test methods, qualification protocols, and reports. Perform QA investigation testing on returned product/field complaints, NCMR/CAPA or manufacturing line issues. Assist in performing complaint investigations and return goods evaluation as assigned. Perform QA related data entry and data analysis. Perform responsibilities for NCMR coordinator. Assist QE in providing manufacturing line support including routine observation of manufacturing activities to ensure compliance with manufacturing process instructions and procedures. etc.

Invenra is seeking a highly motivated Research Associate with a strong background in cellular biology. This individual will support the Invenra antibody discovery platform. Aspects of the job entail mammalian cell culture and assays, analytical flow cytometry, ELISAs, and immunofluorescence/luminescence assays. In addition, the position will involve general ordering and stocking of lab supplies as well as upkeep of standard cell biology equipment (i.e. incubators, biosafety cabinets, etc.). The position requires strong communication and organizational skills as well as attention to detail. etc.

We're looking for passionate laboratory technicians who will support high complexity laboratory testing on patient specimens across various assays and platforms. This role will be performing quality control and quality assurance procedures while complying with all applicable local, state and federal laboratory requirements. The work requires excellent attention to detail, effective written and verbal communication skills, the ability to multitask and be flexible with tasks and schedules, and the ability to work independently in a team environment. This role requires on-site work at our San Francisco location as well as ability to work overtime and off-schedule days as needed. etc.

As part of the pipeline engineering team, you will be responsible for maintaining, improving, and adding to our catalog of production bioinformatics pipelines across an expanding set of modern assays. You will be responsible for scaling our pipelines as we work toward our goal of providing low-cost genetic answers to billions of people. You will work and learn among an extraordinary set of peers: bioinformaticians, molecular biologists, and software engineers. Your work will directly improve the quality of our product and positively impact each tested patient.

The Validation Associate works closely with the Validation Specialist in support of capital, contract, and compliance projects. This position is responsible for executing a variety of validation studies, including performance qualifications and/or requalification’s for terminal and component sterilization work.

The Regulatory Affairs Associate/Specialist supports the regulatory compliance programs by coordinating the scheduled activities of state and federal reporting, as well as medical complaint handling, ensuring compliance with US and International regulatory agencies. Essential responsibilities include but are not limited to: Associate: Compliance: Oversees state and federal certification and registration requirements to ensure compliance with reporting obligations. Conducts project research and gathers supportive materials. Conducts document fact checking/comparisons, log updates, and tracking/archiving/filing backup. etc.

Just is seeking a motivated and creative Associate Scientist, who desires a significant opportunity to improve worldwide access to biotherapeutics. We are looking for a motivated scientist to join a fast-paced, collaborative, and multidisciplinary team. As a member of the High Throughput Analytical group, you will support process development through application of H/UPLC and CE methodologies. Additional experience with other analytical techniques as well liquid handling robotics is a plus. The ideal candidate has strong written and verbal communications skills and works well independently and in teams. etc.

KBI’s Particle Characterization Core is looking for a scientist or engineer to become our next colleague and learn the fine art of particle characterization. Our new associate will have an active role in a dynamic laboratory environment that will include learning cutting-edge analytical techniques, development of data analysis tools, establishing direct relationships with clients, and continuing to build a world-class specialty analytical business. If you are eager to learn and want to jump start a career in pharmaceutical analytics, you might be the person we are looking for! 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.

We are seeking a highly motivated Manufacturing Associate to support our new Viral Vector biotechnology facility in Oceanside, CA. Under minimal supervision, in this role you will be accountable for and focused on front line manufacturing of viral vectors. Responsibilities (include, but are not limited to): Assist with startup activities of a new cGMP facility by collaborating with PD, MSAT, Engineering and Quality departments. Perform all tasks associated with the manufacture of viral vectors following batch records and standard operating procedures (SOPs) to ensure safe and compliant operations. Work as part of a team to execute GMP runs in close collaboration with Process Development and Quality. etc.

We are currently seeking a highly motivated individual to join the KLUS Pharma to support therapeutic antibody programs. Key Responsibilities: Have interest in implementing process improvement technologies, exhibit initiative, work independently, be technically proficient in the processes assigned to them, and be flexible in a start-up environment. Responsible for the antibody screening and antibody identification, activities include but not limited to cell culture and cell cryopreservation, cell fusion, hybridoma subcloning/expansion and supernatant harvesting, high throughput screening large panels of antibodies derived from immunizations and hybridoma pools with ELISA and flow cytometry. 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.

We are seeking a Technologist to join our Reference Microbiology lab team in Burlington, NC! Performs tests and analyses according to established testing procedures in designated technical department. Assays performed in the in our department utilize a variety of scientific techniques, including Performs tests and analyses according to established procedures in designated technical department. Position may perform various techniques including EIA, IFA, and other non-automated and automated procedures. Open to entry level and senior level technologist's candidates as well as Technicians with an associates in Medical Laboratory Technology or Biotechnology. etc.

Are you looking for a career that offers opportunities for growth, continual development, professional challenge and the chance to make a real difference? Are you an experienced Medical Lab Professional or desire to start your career in Medical Lab Science? If so, LabCorp wants to speak with you about exciting opportunities to join our team as a Technician in Winston Salem, NC. In this position, you will work in a fast paced, customer focused, and challenging environment. etc.

Responsibilities: This is a clerical and processing position with no testing involved. Determine the acceptability of specimens for testing according to established criteria. Perform routine and complex technical procedures and functions according to departmental Standard Operating Procedures. Monitor, operate and troubleshoot instrumentation. Demonstrate the ability to make technical decisions regarding testing and problem solving. etc.

Are you looking for a career that offers opportunities for growth, continual development, professional challenge and the chance to make a real difference? Are you an experienced Medical Lab Professional or desire to start your career in Medical Lab Science? If so, LabCorp wants to speak with you about exciting opportunities to join our team as a Technician in Houston, TX. In this position, you will work in a fast paced, customer focused, and challenging environment. The shift for this position will be Tuesday- Saturday 6 am to 2:30 pm. etc.

Perform blood collections by venipuncture and capillary techniques. Prepare all collected specimens for testing and analysis. Order entry of patient and specimen information . Provide superior customer service to all patients and client providers and staff

LakePharma is the leading US-based biologics contract research, development, and manufacturing organization (CRDMO). The company has developed a range of technologies and capabilities in antibody discovery, protein engineering, cell line development, protein optimization, and GMP manufacturing. With comprehensive technologies, integrated platforms, and five facilities located in key biopharma hubs on both the East and West Coast, LakePharma enables and supports the discovery and development of the biologics of tomorrow. Position Summary: Perform supportive activities for general lab readiness, laboratory equipment qualification and method transfers. etc.

We are rapidly growing and seeking a talented individual(s) to join our Molecular Biology Team as an Associate Scientist. The employee will be responsible for executing projects within the laboratory, writing study/research plans, and summarizing data to clients and colleagues via technical reports. The position requires a drive to provide outstanding customer service by maintaining regular communications with clients, meeting or exceeding quality and timeline expectations. etc.

We are seeking a talented individual to join our team as an Associate Scientist/Scientist, based in our Hopkinton, MA facility, supporting the Pharma Assay and Analytics group in the execution of R&D workflows. Essential Duties and Responsibilities: Validate and Perform Cell-based and Enzyme-based assays and related procedures using manual and automated liquid handling equipment, including but not limited to: Enzyme Activity Analysis. Cell-Based Assays. Viral transduction Workflows (BL1/BL2). etc.

To facilitate daily operations at the Coopersburg Laboratory by supporting the whole blood, plasma/serum, anticoagulant, brokered and abattoir departments as necessary. Responsibilities Include (but are not limited to): Prepare formulations and products according to established batch records and work orders. Maintain lot number, batch and equipment logbooks in accordance with established procedures. Perform on-line inspection of components/product and immediately notify supervisor of any problems. etc.

At Latham BioPharm Group, Inc., you will support multiple clients to assure their development phase programs meet or exceed industry cGMP requirements by assisting in the creation and implementing corporate Quality Manuals, Quality Policy’s, SOP’s and training programs. In addition, perform batch record; review, approval and disposition of lots and labels. Manage deviations and CAPA identification to closures. Furthermore, you will provide audit support by assisting in conducting vendor qualification through routine scheduled audits. 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. etc.

KEY ROLES/RESPONSIBILITIES: Processing blood and body fluids from HIV-infected patients. Performing complete blood cell counts and blood cell differential counts on a Sysmex XNL 350i hematology instrument. Performing manual blood cell differential counts. Documenting results. Performing basic data analysis. Performing quality control evaluations. Monitoring equipment for optimum performance and basic instrument troubleshooting. etc.

KEY ROLES/RESPONSIBILITIES: Complete assigned tasks supporting manufacturing laboratory functions. Maintain bacterial and mammalian cell cultures. Perform microscopic technique/cell counting. Operate advanced buffer/media skid, SU and fixed large scale, chromatographic skid equipment, GMP autoclaves and associated equipment, basic lab equipment operation. Follow Standard Operating Procedures. Complete Batch Production Records under current Good Manufacturing Practices. etc.

In our Genomics Division, we use our expertise in DNA extraction, genotyping, sequencing and PCR to enable scientists and companies to feed, cure and protect the world’s population. We supply genomic services from our UK, Germany and US laboratories, to global customers in agricultural biotechnology, molecular diagnostics, research, pharma/biotech, applied and clinical markets. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. etc.

The Machine Operator I is responsible for the setup and operation of standard packaging machinery in the packaging department. This includes working with and monitoring other packaging personnel to complete equipment set up and operation required by the department schedule. Machine Operators must comply with regulatory requirements, Good Manufacturing Practices (GMP), Standard Operating Procedures (SOP), and Manufacturing Process Records (MPR). They will perform all processes as required to fill, label, print, tray seal, pouch, final package, and inspect any Lifecore product; document completed work during packaging of final product; continually practice proper precautions and procedures when working with equipment and handling chemicals; 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.

The Manufacturing Technician (Temporary to Permanent) will perform routine running of manufacturing equipment to support production and R&D efforts. This role will provide feedback to engineering and scientific staff on process performance and ideas for process improvement. Responsibilities: Responsible for running manufacturing equipment to support production and R&D efforts. Collect samples for in-process testing and complete test and inspection activities. Monitor the manufacturing process, recording observations and key run parameters as needed, and adjusting the process as necessary within the defined process window. etc.

Locus Biosciences is seeking a highly motivated and entrepreneurial applicant to join our research and development team as a full-time Data Analyst. This individual will be responsible for assisting in the generation, production and characterization of novel antimicrobial products. Primary responsibilities include maintaining and leveraging data acquired from automated and high-throughput instruments. The ideal candidate will be able to drive the automation of data acquisition from lab instruments, maintain a data warehouse, and derive meaningful insights from large datasets. 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 a passion for data-driven decision making and bringing life-saving therapeutics to patients. etc.

LogicBio is seeking an entry level Research Associate to join our Discovery Biology team. The successful candidate will support the team in performing assays to assess protein expression and function of new targets in our growing pipeline. This role will work closely with other teams internally and externally, and support the analysis of preclinical studies to evaluate therapeutic candidates. Primary Responsibilities: Perform molecular and cellular-based assays to assess protein expression and activity. This includes, and is not limited to ELISAs, SDS-PAGE, BCA protein, and immunoblotting assays. Support assay development team in developing, optimizing and validating assays. Work closely with in vivo pharmacology and R&D teams to support sample analyses. Maintain and update detailed electronic notebook of experiments. Prepare, review and deliver scientific presentations for internal/external use. 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. Collects all process related hazardous wastes and transports to accumulation drums. 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.

Processes active compound materials into final tablet form performing quality control checks to maintain consistency of product according to manufacturing specifications. 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 Manufacturing Associate 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.

Mammoth is seeking a Research Associate with experience in tissue culture and genome editing. The ideal candidate will have experience working with genome editing technologies. Strong candidates for this role will also have experience with molecular biology and cloning. Understanding of CRISPR systems and their applications is a plus. Responsibilities: Work directly with Scientists and Research Associates to develop new CRISPR tools. Establish and maintain mammalian cell lines. Analyze genome editing outcomes with NGS and flow cytometry. etc.

This position will involve the development of in vitro assays to characterize lead clinical candidate molecules in drug development. It will primarily focus on developing both immunochemical assays and cell-based assays to support the development of preclinical pipeline products. Additional responsibilities may include testing early pipeline molecules in established in vitro assays and/or developing novel in vitro assays to support mechanism of action studies. Key Responsibilities: Execute assigned tasks following appropriate laboratory/technical procedures under minimal supervision. etc.

McGuff Pharmaceuticals, Inc. currently has an opening for a Manufacturing Technician within our production facility located in Santa Ana, CA. This position reports to the Production Supervisor. The candidate must be detail-oriented, results-oriented, possess good communication and writing skills, capable of performing assigned production duties and flexible in adapting to changing work priorities. etc.

Medpace is a scientifically-driven, global, full-service clinical contract research organization (CRO) providing Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Medpace’s mission is to accelerate the global development of safe and effective medical therapeutics through its high-science and disciplined operating approach. We leverage local regulatory and deep therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, Medpace employs approximately 2,700 people across 36 countries. etc.

We are looking for a Microbiologist I. Responsible for the testing of samples using various microbiological analyses. The incumbent provides analytical support for the lab by ensuring that laboratory procedures are being performed within specified quality guidelines. This position serves as a technical resource and provides ongoing technical support related to method and process implementations. This position spends the majority of time or all of their time in diagnostics. Follow appropriate methods and SOPS on all tasks. Maintain quality control records. Read, calculate, record data in Laboratory Information Management System. Perform rapid test methods. etc.

We are looking for a Micro Tech. Your missions will be to: Prepare samples for processing and maintains documentation of process to facilitate analysis procedures. This position requires weekend work. The Laboratory Technician we are looking for has… - The ability to work collaboratively, as a member of a team, to achieve a common goal. - A desire to protect themselves, their friends and family, and the entire world from illness caused by foodborne pathogens. - The flexibility and productivity to work in a fast paced, often varied environment. - A strong sense of pride in achieving accurate, timely, and consistent results in their work. etc.

Mérieux NutriSciences is dedicated to improving food safety and quality though nutritional research, scientific excellence and innovation at every step of the food supply chain. Our team of scientists and technicians is committed to providing our clients with accurate results, delivered on time, with uncompromising ethics, honesty, personal integrity and confidentiality. NO PREVIOUS LABORATORY EXPERIENCE REQUIRED. Your Mission: Work as a member of a team to prepare food samples for testing. Carry out a number of procedures including reading test labels and preparing samples for analysis by recording, weighing and blending. Pipette sample solution into tubes or plates according to the analysis process being performed. Set up and sterilizing equipment needed for analysis of food samples. etc.

The unique duties of this position will consist of supporting the development of scalable cell culture processes as well as the manufacturing of primary human cells including activities that involve graft engineering for cellular therapies. Furthermore, you will be responsible for completing successful qualifications and material flow procedures for clean room operations and assisting in the development, writing, and review of SOPs, material specifications, standard manufacturing procedures, batch records and other GMP documentation. This position will primarily involve routine GMP cell processing and facility/equipment support with research and development work on an as needed basis.

As a member of the Miltenyi Biotec Manufacturing team, you will have the exciting opportunity to participate in both the manufacture and process development of T-cells and multiple other cell therapy products within a GMP environment. The unique duties of this position will primarily consist of manufacturing primary human cells including activities that involve graft engineering for cellular therapies as well as supporting the development of scalable cell culture processes. Furthermore, you will be responsible for completing successful qualifications and ongoing support procedures for clean room operations and assisting in the development, writing, and review of SOPs, material specifications, standard manufacturing procedures, batch records and other GMP documentation.

As a member of Miltenyi Biotec’s Process Development team, you will have the exciting opportunity to support the development of new processes that will generate cellular therapeutic products. You will apply your GLP/GMP experience to perform and maintain cell cultures using aseptic techniques. Ideally, you will be able to order materials and maintain inventory with the goal in mind that every effort is aimed at developing and qualifying processes required for clinical cell and gene therapy products. In addition to your primary responsibilities, you will document activities for reproducibility, clean and maintain laboratory equipment and support team members as needed

At Mylan, each person has the ability to make a difference. From the providers who sell and market our products, to the producers who develop and manufacture them and finally to our business partners who support the providers and producers, we all have a mission critical role. Here's how this role will help: Coordinate release documents, perform product releases in SAP, and perform product inspections. Write specifications and SOP’s, perform warehouse investigations, review rejections, place products on quality hold, process sample requests, returned goods and donations, ship studies, and review temperature data. Deliver and create training and help maintain training records. etc.

Duties include: Preforming basic assmebly tasts at a proficiency and quality standard rate set by the plant. Read/follow written build instructions (process sheets) to perform assigned operations.

Newly hired and/or fully trained in one or more areas of quality. Works under close supervision on assignments that are routine in nature where limited judgement is required and typically detailed instructions on work are given. Examines compnay records to secure such information as size and weight of the product and results of quality test. Inspects produc to determine compliance with order specifications.

Works independently with general supervision and works on assignments of moderate scope where judgement is required in resolving problems and making recommendations. Will exercise judgement within defined procedures and practices to determine appropriate action, and normally recieves general instructions on routine work and detailed instructions on new assignments.

Works under general supervision on assignments that are semi-routine in nature where ability to recognize deviation from accepted practice is required. Normally recieves general instructions on routine work and detailed instructions on new assignments. Performs internal audits for processes and products to assure compliance to the documented quality system.

Operate Active Pharmaceutical Ingredients (API) manufacturing equipment to achieve production goals. Work in a safe & environmentally responsible manner. Real time review of electronic batch records ensuring compliance to Standard Operating Procedures (SOPs) & current Good Manufacturing Practices (cGMP) standards. Utilize investigation skills during troubleshooting & assist during equipment maintenance, including restoration of lost function, predictive & preventative maintenance

The Respiratory Therapist will be responsible for performing all duties associated with respiratory function testing in accordance with Study Protocol and Standard Operating Procedures (SOPs).  Responsible for performing and documenting respiratory function testing; observes dosing of study subjects to ensure appropriate respiratory function and compliance.  Performs and documents drug devise training.  Observes participant behavior during the study and will communicate pertinent observations and adverse events to the Study Manager or Investigator.

The entry level Research Technician will be responsible for supporting study progression according to study protocol and Standard Operating Procedures.  Responsible for obtaining vital signs, performing EKGs, and drug/pregnancy testing from study participants as required by the protocol.  Observes, obtains and processes all laboratory specimens. Performs service oriented duties along with stocking supplies and general support to all phases of screening process.

The entry level Research Technician will be responsible for supporting study progression according to study protocol and Standard Operating Procedures.  Responsible for obtaining vital signs, performing EKGs, and drug/pregnancy testing from study participants as required by the protocol.  Observes, obtains and processes all laboratory specimens. Performs service oriented duties along with stocking supplies and general support to all phases of screening process.

High throughput data processing and management. Algorithm development and optimization. Algorithm parallelization via General Purpose GPU computing. Computer vision, image creation, and image processing. Eliminating defects in our code and refactoring it to reduce its length, complexity and time required to test or add functionality

Support of QC Laboratories including, but not limited to: Work with the procurement department to order reagents, materials, services and equipment for QC. Maintain inventories of materials for the QC departments. Perform equipment/laboratory cleaning and routine maintenance tasks. Responsible for washing and maintaining glassware.

Write standard operating procedures, work instructions, forms, material specifications, deviations, CAPA's, change controls and other relevant GMP records. Perform sampling, inspection and release of incoming material. Perform sampling and inspection intermediate and final product. Assess supplier quality performance

The Regulatory Affairs Analyst II maintains responsibility for the review and investigation of medical device complaints. He/ she coordinates the resolution of complaints and ensures that timely investigations are performed. The incumbent prepares and files Medical Device Report (MDR) for Medical Systems Group(MSG) products. The incumbent maintains quality documents to ensure compliance with FDA regulations and guidance documents relating to these areas of responsibility. He/ she functions as part of MSGs Regulatory Affairs team in fulfilment of corporate objectives for FDA regulatory compliance. The Regulatory Affairs Analyst II performs routine assignments with occasional direction from supervisor;requires general instruction for new or special assignments from Supervisor and/or more experienced staff. 

The Endoscope Technician must understand and accept the responsibility to ensure the safety of all Olympus products that are repaired by strictly following established processes and procedures. Under the direction of the Manager, the incumbent shall evaluate, troubleshoot, disassemble, assemble, repair and inspect Endoscopes, Electronics, or Microscopy products to meet company product standards and ensure full and proper functioning of the repaired product. Level I Technician: Assignments are semi-routine difficulty level. Requires daily supervision, detailed instruction on new assignments.

As a Field Service Engineer, the incumbent will engage with some of the country’s most influential hospitals and work closely with our world-class sales teams. He/ She will use your in-depth knowledge of our products to provide expert technical support to our existing and new customers. Perform new equipment installations, upgrades, post installation testing, troubleshooting and all other aspects of technical support for all assigned products. Build and maintain relationships of trust with customers by responding to inquiries and complying with all regulatory and quality requirements.

Assists project managers in clinical study conduct for ophthalmic clinical projects across all investigator sites and ensures compliance with protocol and overall clinical objectives. As a member of the clinical team, relies on instructions and pre-established SOP’s to perform the functions of the job while working under immediate supervision of a supervisor or manager.   Performs day-to-day activities under the guidance of the project managers.

The Human Tissue Processing (HTP)  Production Associate I is an entry level position.  The HTP Production Associate I will perform the production activities associated with HTP Products, produced at Organogenesis Norwood, with supervision. The associate will adhere to the appropriate SOPs, MBRs, and cGMP procedures in the general lab area as well as the Class 10,000 clean room.  The HTP Production Associate I will report to the HTP Supervisor.

Research Associate in Protein Department: TheOriGene ProteinDepartmenthas been developing genome-wide purified recombinant proteinfrom human HEK293 cells, over-expressed lysates,Knockout (KO) cell lysates,cancer cell lines lysatesandheavy-labeled full-length protein.We are looking for individuals who would like to be a part of our Protein Department. Willingness to learn relevant molecular biology, transfection and hands on skills of various biochemical assays such as SDS-PAGE electrophoresis, BCA, ELISA. Western blot, recombinant protein purification

To assist Territory Manager in achieving sales results at or above established quotas for total and individual product segments. To provide direct, personal and timely service, via a consultative approach, to physicians, podiatrists, patients, managed care or other payors, representing Orthofix in a professional and straight forward manner. Additional responsibilities will include managing, directing, and assisting any authorized Orthofix distributor. Some shift in emphasis from calling on doctors to calling on payors is dictated by changes in the health care environment.

The Client Specialist (CS) is a full-time, on-site position to support testing department client account operations. This position will work closely with Pacific BioLabs Testing Department Heads and Business Development in ensuring that Client/Sponsor testing needs are met. The duties of the CS include 1) supporting the Client Account Manager in quote creation and quote follow-up and 2) department log-in and study file preparation.

he primary role is to interface with scientists to understand their workflows, and then develop automated solutions based on in house equipment or by identifying and bringing in the proper equipment/software solutions.  More specifically the role requires scripting, testing and validating method and process development on Hamilton Vantage and Star liquid handling platforms, as well integrations with Agilent, Thermo, and other automation equipment.

Perform flow cytometry staining, sample acquisition, and analysis on clinical patient samples according to established standard operating procedures. Thoroughly document all work according to good documentation practices. Communicate clearly and concisely, both verbally and in the form of written reports.

Looking for an enthusiastic team member to join Pall’s Inorganic Additive Manufacturing Team. Associate should be ready for hands-on engineering work in addition to working in a team environment. Duties: test stand set-up and evaluation; becoming subject matter expert on related processes; critical thinking and data analysis; creating 3D drawings; general lab duties

This is a laboratory-based position with great career potential for a junior scientist or technically oriented entry level candidates who already have or wishes to gain hands-on molecular biology experience in the next-generation sequencing space. This position offers a rare opportunity to build a strong multidisciplinary foundation in an exciting space. The ideal candidate must have good interpersonal and problem-solving skills. He/she should be driven to learn and motivated to develop great products and maintain the highest quality standards.

Provide programming skills and expertise in the design and development of Enterprise Architecture projects: System Integrations, Analytical and Metrics Clinical Data Warehouse, Management of Production Release processes. Independently implement solutions following provided design blueprints, using established frameworks and design patterns, adhering to requirements, standards, and functional specifications. Responsible for unit testing of all code produced using preferred unit test frameworks and technologies

The Laboratory Technician is responsible for product manufacturing and ELISA kit optimization and stability testing following established guidelines and procedures and completing required documentation. The individual will routinely analyze raw data and generate summaries of work performed in compliance with Standard Operating Procedures (SOPs).

The R&D Scientist is responsible for the hands-on development of immunoassays, such as ELISAs and cell-based assays, for commercial production. This individual plans and executes design, development, and Manufacturing transfer of bioanalytical assays for product commercialization. The R&D Scientist is also responsible for development of custom assays and reagents for clients.

The Validation Analyst I is responsible for overall validation project ownership of limited risk project(s) under heavy supervision. Responsible for generation and execution of validation protocols, assistance in audits, and determination of validation needs. This job has no supervisory responsibilities.

This position will work to continuously improve processes and systems that ultimately lead to improved profitability to the company. Using all available Engineering, Lean and Six Sigma tools, this position will work independently and cross functionally to drive out waste and reduce process variability. Gather and analyze data using the operations data collection systems, including but not limited to: Overall Equipment Efficiency (OEE), uptime, scrap, margin, staffing, quality, capacity, safety and direct labor cost per unit to facilitate decision-making as well as identify and prioritize initiatives. This will require ownership of the data collection systems to insure the purity and consistency of the source.

The role of the Helpdesk Technician is to assist customers with IT applications, products or services. Complex and/or high priority problems are elevated to specialized support groups for resolution however the HelpDesk Technician is responsible to ensure that an effective solution is provided to the user. Provides support for all Information Technology products and services. Support may include answering questions, troubleshooting problems, teaching or instructing customers regarding software or hardware functionality, and communicating policy.

PCI Synthesis is a leading manufacturer of Active Pharmaceutical Ingredients (APIs) and clinical drug substances. We are seeking a highly motivated, experienced Kilo Lab Research Scientist who would like to join our growing company. Proactive participation on project teams to guide R&D work prior to manufacturing runs • Preparation of Master Production Records (MPRs) based on lab procedures from R&D • Preparation of other regulatory documents • Active involvement in troubleshooting + investigations when problems are encountered.

MVI Health is developing a revolutionary new product that uses state-of-the-art virtual reality technology to transform physical rehabilitation. As our QA Tester and Generalist, you will play a key role in ensuring quality in our product in order to deliver a great experience to our customers. If you are a fire-and-forget tester who can solve problems independently, and who wants to make a positive difference in people's lives, this position may be for you.

As an R&D Engineer at Penumbra, you will be charged with designing game-changing medical devices to address some of the world’s toughest disease states. Design, prototype, and optimize meaningful medical devices that revolutionize treatment paradigms for a variety of challenging disease states. Create test protocols and conduct testing to mitigate clinical risk for a wide range of medical device concepts. Coordinate with suppliers and other external resources to source components and refine component specifications.

Seeking candidate who will work as part of the production team to manufacture Next-Gen Sequencing library kits. Job duties include but are not limited to: Making and testing kit components. Quality Control. Pipetting reagents. Labeling tubes

The Associate Inside Sales Representative will act as a lead generation professional working closely with a team of Key Account Sales Specialists, Inside Sales Representatives and the Regional Sales Manager. They will plan and conduct outbound calling and/or email correspondence to targeted prospects and clients, and qualify leads generated by the Marketing team. Position partners closely with the regional sales team to effectively drive business in the region.

The Allegan Michigan based Analytical Research and Development department, specializing in solid and liquid Over-the-Counter (OTC) product development, is looking to add a talented colleague to our New Product Development team. Our focus is on the development of analytical methods for small molecules in support of research and characterization of new and reformulated drug products. Chief techniques include HPLC/UPLC-UV stability-indicating methods with various separation chemistries. Perform physical and chemical testing on raw materials, in-process and finished product samples with superior attention to detail and a focus on operational excellence.

This is a Florida based Patient Sales Advocate position. Your position will be a blended position where you will work by phone calling patients and presenting The Eclipse solution as well as meeting with patients and medical practitioners in the field to educate and present the product. The ultimate goal of your phone calls is to convince the patient to schedule an appointment with a doctor to seek further information. The goal of your field work is to educate patients and practitioners on the benefits and use of the Eclipse solution.

This position will be responsible for customer relationship management through the effective use of technical knowledge to install, troubleshoot, service, and maintain equipment at customer sites; generate service revenue; adherence to state and federal regulatory requirements. This position is an entry level position for an employee with limited experience. 

Research Support Instruments is looking for a scientist/engineer with a broad range of experience for the development of optical space flight instrumentation. Contamination in the form of particulates, films, or scattered light can significantly degrade instrument performance and/or lifetime. Management of the cleanliness of optical and nearby surfaces throughout the lifecycle of assembly, integration, test, launch and operations requires a system approach. A successful contamination control engineer must work with designers and engineers throughout the entire process: design, process control, monitoring, cleaning, training, performance modeling, integration, and testing.

To ensure the timely and accurate inspection of raw materials, in-process blends, and finished drug products while adhering to the cGMP and ICH guidelines as well as USP/NF/EP/JP/Health Canada, and other regulatory statues as written. To ensure that the day-to-day tasks of the Quality Assurance Unit supports the overall business plan while maintaining the highest quality drug products, ensuring the safety, identity, strength, purity, and quality that the drug is purported to possess.

We are looking for a driven independent thinker with a monster work ethic who shares our long‐term vision for developing a source of donor-independent human platelets, and leveraging Mother Nature’s drug delivery system to cure diseases. Perform maintenance and differentiation cultures of human induced pluripotent stem cells, hematopoietic progenitors and megakaryocytes. Perform routine cellular and molecular biology procedures including but not limited to flow cytometry and microscopy

The Chemist I position, reporting to the Director, Analytical Development, will operate under moderate supervision to perform chemical analyses of samples according to standardized procedures to determine the identity, content, purity, stability, and other characteristics of the samples analyzed. He/she may perform method development activities related to the development of methods for testing of raw materials and clinical drug product as well as formulation development.

Prepare samples for analysis, analyze, and report results. Prepare controlled documentation in support of the sampling, analysis, and reporting of results. Analyze data with respect to standards or to previously determined parameters. Perform sampling and testing of raw materials according to PPL-SD procedures.

The Research Associate will play a key role in advancing exploratory gene therapy programs that leverage our cutting-edge piggyBac® DNA Modification technology. Actively participate in our proprietary gene therapy platform technologies to create new human therapeutic candidates. Develop and perform research involving various in vitro and animal laboratory techniques including PCR, ELISA, cell/tissue isolations, microscopy, in vivo procedures and animal imaging

The Research Technician will play a key role in advancing exploratory gene therapy programs that leverage our cutting-edge piggyBac® DNA Modification technology. Actively participate in our proprietary gene therapy platform technologies to create new human therapeutic candidates. Develop and perform research involving various molecular and cell biology techniques including nucleic acid development, transfection, cell culture and transgene expression.

Assists in formulating and defining systems scope and objectives through research and fact-finding combined with a basic understanding of business systems and industry requirements. Analyzes business and user needs and documents requirements. Gathers and writes requirements and design specification for basic to moderately complex systems. Verifies requirements and design comply with industry regulations and SOPs/WPDs.

As an Assistant Scientist, you will use state-of-the-art technologies to perform high-quality sample testing for key pharmaceutical clients across the industry. Your sample preparation and sample analysis serves as an integral piece in helping PPD accomplish our goal of helping bring life-changing therapies to market. Performs a variety of routine sample preparation and analysis procedures to quantitatively measure pharmaceutical and biopharmaceutical compounds in a variety of formulations and/or biological matrices for stability and analytical testing.

As a QA Auditor I, you will assure the quality of lab data and reports. Conduct internal and/or external audits to ensure compliance with established quality assurance processes, standards, global regulatory guidelines and/or client contractual obligations. Identify and address non-conformance issues. Assist in the delivery of quality services for contracted quality assurance audits, internal site audits, laboratory audits and file audits for clients and projects. Apply company policies and procedures to resolve routine issues.

In this role you will: You will process fresh patient specimens and nonclinical samples. You will perform PMBC or cell subset isolations, plasma fractionations, serum separations, cell thawing, cell counting and generating whole blood aliquots. You will receive and process nonclinical samples such as whole blood units and/or leukopaks.

Responsible for assisting with site feasibility and recruitment, including drafting of Site Information Questionnaires. Review assigned clinical documents for clarity and accuracy. Participate in the design and implementation of case report forms (CFRs), CRF and completion guidelines. Responsible for creation and update of Investigator Site Files from template supplied, including printing of required study documents. Review of data fields within the electronic data capture (EDC) systems, including performing and collating and downloading reports to support study management and data review

The Quality Associate serves as a member of Progenity’s Quality Management team, whose focus is on supporting quality processes required by CLIA, CAP, NYS and other state and local requirements to ensure quality of patient test results in collaboration with the laboratory medicine and operations teams.

Provide CSV authoring, review and approval of validation documents developed by functional validation teams, ensuring the documentation meets regulatory requirements and quality standards. Initiate/update GxP and Risk Assessments on system.Author, Initiate, and/or review and approve IT SOPs related to compliance

We are looking for a highly motivated Research Associate in behavioral neuroscience. The successful candidate will work in a team of scientists and researchers supporting the preclinical studies using rodent models and tests. The primary responsibilities of the candidate will include but are not limited to conducting preclinical research of drug abuse liability, pain, cognition, and other assays as needed. The candidate must be capable of working across teams and independently.

The Molecular Biologist is responsible for performing scientific experiments that contribute to research and drug discovery activities at PTC. This position assists in the conduct of early stage research, the goal of which is applying new state-of-the-art technologies to research projects as well as the advancement of research programs. The Molecular Biologist is also responsible for communicating experimental results to his/her supervisor and the project team.

The BS/MS Research Associate, Analytical Development - Gene Therapy is responsible for assay development and/or routine testing including, but not limited to, AUC, qPCR, cell-based assays and immunoassays. S/He is responsible for hands-on lab work, documentation and communicating results to his/her supervisor.

The Clinical Research Associates (CRA) is responsible for assigned aspects of clinical monitoring and site management in accordance with the Code of Federal Regulations (CFR) of the Food and Drug Administration (FDA) and the International Conference on Harmonization - Good Clinical Practice (ICH-GCP). Site visits are conducted to assess protocol and regulatory compliance, data reliability, and the proper care and treatment of study subjects. Please note: This is not a remote position.

The Pharmaceutical Technician will efficiently, effectively, and safely clean, set-up, and operate machinery in the manufacturing and/or packaging area while adhering to applicable cGMPs, SOPs, FDA, and DEA guidelines. Follow Master Batch Records for the manufacturing and packaging of controlled, oral solid dose (OSD) and other dosage forms when required. Prepare raw materials, blends, and bulk accountability throughout manufacturing processes. Performs weight checks for incoming and dispensed materials ensuring compliance with established procedures. Operates scales including set-up, verification, leveling and challenging.

Under general supervision, perform various manufacturing related activities for a GMP compliant Fill/Finish operation applying standard practices, techniques and procedures.  Able to assist in the preparation of reports, records, etc., for assigned tasks.

The Technical Associate in Kit Assembly comprehends and performs assigned manual production tasks according to established standard operating procedures. Responsible for Manual production and assembly procedures in compliance with relevant regulations and Standard Operation Procedures. Adhere to and accurately complete all production-related documentation. Responsible for set up, trouble shooting and operation of production related equipment within the assembly area.

Perform routine lab operations, such as preparing reagents, pipetting, weighing, monitoring, recording, and replenishing supplies. Assist supervisor in performing analysis of drug or other targets in complex biologic matrices. Set-up, use and maintain complex instrumentation. Document experiment details, calculations, results and observations in accordance with GLPs and SOPs

This position is responsible for managing the quality of the capsule product on their assigned machines by monitoring and evaluating the process, observing trends, adjusting/replacing minor equipment and performing general improvements on the capsule manufacturing machines. Maintain all documentation of production batches while on the production floor.

Perform sampling, inspection and testing of incoming consumables and raw materials per compendial and non-compendial methods for GMP use in manufacturing. Perform physical inspection of Bulk Reagents and Assay Kits to support Kit release. Monitor, analyze and trend inspection/testing results and quality data

Quidel is searching for an Development Associate to join our team in the Beverly, MA location. The Development Associate will participate in Research and Development activities toward development, enhancement, validation, and transfer of molecular diagnostic assays or associated technologies to manufacturing. The responsibilities include activities to support research and new molecular product development and also include activities to support manufacturing reagents for molecular diagnostics products.

Located at South San Francisco and Boston, we are expanding and have several entry level technician positions available. We offer competitive wages and growth opportunities within the company. Handle customer samples and perform DNA sequencing and Molecular Biology experiments . Prepare and set up customer sequencing samples. Set up molecular biology experiments as requested or needed

The position may reside in any one of the functional areas and carry out the responsibility under some supervision: Analytical method development, validation, and transfer activities. Formulation development work including Material characterization and physical testing. API/raw material sampling and testing, In-process and finished product testing, cleaning verification swabbing and testing.

The position may reside in any one of the functional areas and carry out the responsibility under some supervision: Operate and troubleshoot the following instruments/equipment to test pharmaceutical samples. Follow analytical test methods, compendial methods, experimental procedures and SOP’s. Document test results in laboratory notebook, in real-time, and communicate status of test results to supervisor

To maintain and coordinate Quality Systems related documents for compliance with cGMP and company procedures with minimal supervision. To review and write cGMP procedures under supervision. To process changes in controlled batch records via Change Control process. To issue effective documents including procedures, forms and batch records. To process changes to the procedures.

The successful candidate will be responsible for the design and execution of experiments to understand the mechanisms of neurodegenerative diseases, discover new therapeutic targets and validate novel therapeutic strategies. We are looking to recruit a candidate with in vitro experience and strong in vivo expertise in neuroscience and models of neurodegenerative disease. Perform cell culture and cell-based assays with immortalized cell lines and primary neurons.

Summary: Validate/qualify equipment, systems, and processes in accordance with regulatory requirements and support, follow and implement company manufacturing standards policies and procedures. Generates, executes and/or reviews master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria

Execute scientifically rigorous formulation screening, development, stability, and characterization studies to select stable formulations for our proprietary recombinant AAV gene delivery products. Perform laboratory studies to develop and characterize formulations and processes, using a variety of analytical techniques. Generate protocols and reports on the experimental work and deliver progress presentations at the team and department level

The Gown Qualified Operator is responsible for the full spectrum of duties in assigned filing room.  This may include but is not limited to: set-up of room and equipment for production, operate equipment to meet product specifications and batch record requirements, ensures correct components and product according to production schedule and batch record, equipment and room cleaning and sanitization, etc  This is a 3rd shift position.

Mechanical assembly and testing of custom TFF systems per assembly drawings, SOP’s, and batch records. Point to point wiring, installation of cables, installation of software, and packaging of final product. Operates and maintains production equipment as it relates to manufacturing operations. Maintains records to comply with regulatory requirements. Documents all work on batch records according to Good Manufacturing practices. Performs batch record review as required by Production management

The Research Associate will assist project managers in day-to-day operations of either federally-funded or commercial studies.  This is an entry-level position. This is not a laboratory research position. The position will offer the opportunity to participate in all aspects of clinical research support, including document preparation, maintenance, and filing; meeting coordination and support; and data management activities including data entry and review.

We are seeking an Associate Engineer (contract) to support solution preparation and process support activities within the upstream and downstream process development of Red Cell Therapeutics at our Cambridge, MA location. This associate will perform tasks including preparation and characterization of raw material stock solutions, upstream media formulations, and downstream process buffers while also contributing significantly to the buildout of infrastructure, workflows, and procedures needed to ensure consistent delivery of solution requests and traceable documentation of all source materials. 

Develop robust and scalable downstream processes in laboratory scales for the purification of antibodies or antibody-based therapeutic proteins with chromatography (affinity, IEX and/or HIC, etc.). Support scale-up of downstream processes and technology transfer to cGMP manufacturing facilities for clinical material production, work with cGMP manufacturing team to generate and review SOPs and batch record for traceability.

The Maintenance Technician is responsible for supporting the design, installation, maintenance, troubleshooting and repair of all site-wide equipment in order to maintain a Quality Class A environment in GMP facilities. This position will have interactions with HSE, Engineering, Outside Contractors/Consultants, Industrial Operations and Research & Development departments.

Level I Specialist primary duties include Tier 1 technical support, including software/hardware installation, troubleshooting, hardware break/fix, VoIP phone support and asset management. Provide Tier 1 technical assistance for computer hardware, software systems, and printers/copiers. Analyze, troubleshoot and resolve reported issues (software, hardware, and processes) in a logical and systematic method

This Team Member will undergo stringent training program to become qualified to work in aseptic environment inside ISO 7 rooms and ISO 5 workspaces ensuring admixtures are completed properly per FDA and cGMP requirements. Undergo thorough training curriculum on gowning, compounding, aseptic manipulations, USP 797 regulations, FDA cGMP-503B regulations, media fills, internal SOP's.

A Chemist I isresponsible for manufacturing products to meet or exceed customers' specifications according to manufacturing procedures by adherence to the Scantibodies Quality System and in compliance to the FDA/ISO 9001 and GMP guidelines, with moderate supervision. This employee is required to assist the supervisor and manager with production improvement, process trouble shooting, and new product development. In addition to regular production activities, this employee also is required to participate in production improvement and research related projects.

This is an opportunity to get a jumpstart in the biotechnology industry and gain practical work experience while attending school at the same time. This position will perform routine tasks in support of analytical and preparative procedures required for the purification, analysis of antibodies and associated reagents used in the scientific community.

Santa Cruz Biotechnology has an immediate opening for an entry level Research Assistant at our Ketchum, ID campus. Ability to perform standard analytical and preparative procedures required for the development and analysis of monoclonal antibodies. Ability to characterize antibodies by designing and optimizing experiments, interpreting data, and selecting the best possible products to develop. Capacity to utilize established, routine procedures and follows instructions from lab supervisor.

The QC Data Review Specialist will be responsible for GMP review and comment on laboratory raw data, procedures and reports to ensure methods, protocols and other procedures were properly followed, results are analytically accurate and correct, and that all documentation meets GMP standards.

Supports lead biostatistician on clinical studies; may serve as lead biostatistician with oversight from a more senior biostatistician. Maintains the statistical integrity of clinical trials analyzed by SDC. Assists in preparing statistical analysis plans, preparing data deliverables for clinical study reports, interpreting analysis results, and writing statistical sections of clinical study reports.

This position participates in a team of technicians responsible for animal husbandry and antibody production activities. All job responsibilities to be conducted within standard operating procedures and regulatory compliance. 1. Clean and disinfect cages, rooms and support areas. 2. Feed animals; maintain water systems, ventilation settings, pest control, and related tasks. 3. Conduct animal identification, animal breeding programs and related tasks.

https://www.seattlegenetics.com/careers/job-opportunities?p=job/orMybfwG&nl=1

Laboratory Bench Position that performs routine release testing for raw materials, intermediates, and final products within a cGMP environment. Perform testing of raw materials and products. Perform instrument qualification and maintenance. Perform test method validation/verification. Review analytical data for completeness, accuracy, and compliance.

A Quality Control Technician works independently to provide quality control support of any area assigned where Sedia Biosciences is responsible for adhering to current Good Manufacturing Practices (cGMPs) for adherence to FDA regulations and applicable ISO standards including warehouse, manufacturing processes, inspection, labeling and packaging, batch record review/disposition, and new product design review and transfer activities.

The Mass Spectrometry group is focused on using the latest MS and associated instrumentation for proteomics molecular profiling. Areas of specific responsibility and attention will include: Carefully perform procedures on experimental samples derived from blood and blood products, urine, saliva, and other biological fluids or tissues. Perform routine calculations, data entry, and lab notebook maintenance, including electronic notebooks and other data annotation, curation, and storage formats.

The R&D Mechanical Engineer is responsible for assisting in the design and development of innovative instruments and consumables for IVD medical devices. The candidate should be familiar with designing mechanisms, device enclosures, machined or injection molded components, and complex assembly methods. An understanding of material selection to optimize mechanical performance, sterilization effectiveness, and biocompatibility is required. The engineer will contribute to the R&D Engineering Department by owning instrument design solutions, test method development & design for manufacturing.  

The Donation Operations technician is responsible for inventory receipt and management, movement and tracking in accordance with GMP guidelines and Seres policies.  The technician is responsible for laboratory assays to examine and characterize donor microbiomes. This position will assist in and/or lead deviations and corrective action plans as they relate to core responsibilities as needed, and perform project based work for program improvement and growth.  Some cross functional work may be required. 

The Regulatory Documentation Specialist is responsible for supporting the Regulatory Affairs Submission Team with the preparation of regulatory documents for both eCTD (electronic common technical document), as well as traditional paper submissions.  The scope of this role includes assisting in the document remediation and formatting of documentation for submissions to Health Authorities.  The ideal candidate for this entry level position is enthusiastic, highly organized and flexible.

This role will be responsible for the picking of production orders and placement of inbound materials. You will also be responsible for deliveries of materials to manufacturing. In addition, you will be required to have an active role in cycle counting inventory. You should be able to handle cross functional duties (ie Shipping, Receiving) within the area.

The Field Service Technician must perform scheduled maintenance, troubleshooting, part replacement, and retrofits as necessary to maintain quality and availability for our customer.  Must maintain safety and professionalism and keep accurate and detailed records of parts used and work performed

The Systems Engineer will be responsible for supporting every phase of the product development life cycle process in order to deliver high-quality products in the consumer and medical device markets.  The Systems Engineer will work with the electrical, software, mechanical, product technical support, and quality teams to help develop, integrate, and test sub-assemblies into product. The ideal candidate has broad skills but deep knowledge/skills in one area, and is able to blend human-centric design with sound engineering principles across a wide range of engineering domains with a focus on quality and willingness to wear many hats.

The ideal candidate will be hard-working and ready to be hands on. In this role, you will have a chance to participate daily in our research by working closely with our study directors, senior technicians, and scientists in order to conduct studies. Animal Technicians begin by learning the basics of data collection and animal husbandry and have the chance to move up into high level Technician roles.

The ideal candidate will have a passion for animal welfare and a great work ethic. Hard-working individuals looking for a great environment and a chance to make a difference will fit right in. Your primary role will be taking care of our animals and sanitizing their housing and our buildings.

Must be very customer focused to both internal employees and external clients. Must be able to work within the FDA regulated environment per its specific requirements and those established by internal policy and standard operating procedures. Computer experience necessary or willing to take internal courses to gain such information quickly.Ability to work with Microsoft Office (Outlook, Excel, Word) a plus. Experience using ERP or inventory systems is not required, but helpful.

The Distribution Associate I will interact with the WMS, TMS, RF scanning and/or other warehouse equipment to perform intermediate level distribution tasks in accordance with defined job processes. They will perform these tasks with a focus on safety, quality and productivity. They must comprehend and demonstrate compliance with Standard Operating Procedures and work instructions. The Distribution Associate I is responsible for providing constructive input to enhance the work process and environment.

Responsible for hands-on execution of all activities in the manufacturing area including the processing and packaging of human tissue products for transplantation. All duties are performed in compliance with FDA cGMP/cGTP requirements, American Association of Tissue Banks (AATB) standards, and Osiris Therapeutics Inc. standard operating procedures (SOPs). The candidate should have a commitment to high standards of quality

The PSR Specialist I contributes to the strategic management of global adverse event reporting, communications with regulators, and risk management activities through the execution of timely, high quality and consistent processes. This role contributes to the on-going improvement of processes, including appropriate identification and response to risks, adverse event reporting decisions.

The FSS will work closely with current customers as well as potential customers as the clinical expert on the sales team.   The Vascular Access devices provide healthcare professionals access to patients’ vasculature for delivery and withdrawal of fluid and medication, as well as devices to protect health workers by helping prevent needle stick injuries.The FSS will work closely with current customers as well as potential customers as the clinical expert on the sales team.   The Vascular Access devices provide healthcare professionals access to patients’ vasculature for delivery and withdrawal of fluid and medication, as well as devices to protect health workers by helping prevent needle stick injuries.

This individual will contribute to providing microbiological support and testing of cGMP environments, as well as contribute to in-process, drug substance, and drug release testing. Environmental monitoring of cGMP cleanrooms per FDA and USP guidelines. Input and manage environmental data. Conduct QC testing of raw materials and utility samples; QC tests include, but not limited to bioburden, endotoxin, total organic carbon, conductivity, osmolality, and pH.

We are currently seeking a Research Associate for the Nanoformulations group. This individual will play a critical role in supporting experiments to identify and evaluate molecules for nanoparticle formulation and drug delivery. They will be responsible for performing routine laboratory analysis and maintenance. We are currently seeking a Research Associate for the Nanoformulations group. This individual will play a critical role in supporting experiments to identify and evaluate molecules for nanoparticle formulation and drug delivery. They will be responsible for performing routine laboratory analysis and maintenance.

The Materials Associate's responsibilities are divided into three primary functional areas: shipping and receiving, inventory accountability, and other duties. Create and maintain inventory records and forward to appropriate departments. Issue supplies, materials and equipment to workers and ensure that all corresponding paperwork is accurately managed. Perform physical inventory inspections to ensure 100% of inventory accuracy.

Sorrento Therapeutics’ is seeking an experienced Research Associate who will be responsible for the development and implementation of in vitro functional T cell assays to support pre-clinical validation of CAR-T cellular therapies against cancer. The individual must have knowledge and hands on experience in CAR-T, cell culture, Flow cytometry and T cell biology. 

Spherotech, Inc. seeks a college graduate for a Quality Control Associate opening. Duties include final product inspection, documentation, Quality Control testing etc. This position requires a Bachelor's degree in Chemistry or related field and a minimum of 1 year of experience.

Plan and maintain detailed integrated master schedule (IMS) combining multiple projects/product lines including design and program milestones, manufacturing development, assembly, test, and into production operations. Assist in laying out and tracking major project milestones, workflow, and activities in relation to schedule and resources and identify gaps and constraints in program performance. Interface with Engineering, Finance and Business Operations, and Program Management to develop program requirements into the IMS baseline.

Perform force and functional testing and data calculations for injector cartridges. Perform QA review of Device History Records. Maintain Device History Records. Inspect, sort, disposition and transfer of returned product from receiving dept., mail, customer service or other.

Thorough knowledge and appropriate implementation of basic production functions. Completes required production documentation accurately. Consistently meets quality and productivity targets. Appropriately follows company policies, rules, and regulation

Design, develop, and implement automated systems to test product in a manufacturing environment, at component, subassembly and systems levels. Perform product requirements analysis, test requirements definition, test system hardware and software design, systems integration, and validation. Generate design, validation, and maintenance documentation to comply with corporate quality system and department policies

Generate component requirements and review and contribute to system performance requirements. Lead the Electro-Acoustic Engineering team in documenting specific requirements in the SyRS’s and the SDR’s using the Hardware Development Hearing Aid Design Guide as a high-level reference. Work with the Project Manager to manage work efforts to ensure project schedules are met and areas of high risk are identified and mitigated with appropriate risk mitigation plans. Follow the Electroacoustic Engineering Product Development Process. Perform electrical and electro-acoustic design tasks and provide input into project timelines and schedules.

Design, develop, and implement automated systems to test product in a manufacturing environment, at component, subassembly and systems levels.Perform product requirements analysis, test requirements definition, test system hardware and software design, systems integration, and validation. Generate design, validation, and maintenance documentation to comply with corporate quality system and department policies

This position is responsible for performing/controlling a combination of manual or automated tasks necessary for the receipt, storage, and shipment of product. This may include functions of receiving, picking, packing, shipping, staging, transporting, storage, delivery, etc. 

This position is responsible for performing a variety of duties in support of the maintenance of buildings, facilities, and grounds. Also, this position is responsible for a variety of cleaning duties, a variety of other building maintenance work, and related duties as assigned.  Sweep and mop floors, clean windows; clean restrooms and fixtures; clean and maintains lunch and break rooms. Strip and wax tiled floors as required; vacuum, buff and wax floors.

Performs medical device evaluations and monitors the quality of outgoing medical devices.  Evaluates incoming medical devices in accordance with procedure guidelines to accurately prepare service/repair estimates. Performs routine testing for product release. Validates accuracy of outgoing repair documentation. Provides feedback to QA and production departments concerning technician and product performance.

Position acts as Trusted Advisor to STERIS Customers in maintenance and procurement of medical devices and consumable products as part of a high performing team. Drive an exceptional Customer experience by providing on-site preventative maintenance, troubleshooting, repair, equipment modification and installation support on complex mechanical, electro-mechanical and electronic units in a high stress healthcare environment. Provide superior Customer service by pro-actively interacting and communicating with Customers.

The primary role of the Repair Technician is to perform repairs on medical instrumentation.  Technicians will be trained to become familiar with various types of surgical instruments and understand how to best maintain and repair them.  Repairs are completed on a repair truck onsite at a hospital or surgery center.  In addition to repair work, Technicians may work with a team including Sales Representatives and RCs (Repair Consultants/Managers) to identify and capitalize on revenue opportunities.

We are looking for people who have the enthusiasm andmotivation to be a highly contributing member of a small team. This opportunity will offer the employee the ability to work closely with the founding team, as well as to form closepartnerships with team members during the development and formation of the company. Executing molecular biology experiments including molecular cloning, bacterial transformation and mammalian cell culture.

Performs entry level specialized computer numerical control (CNC) machinist work for Structure Medical, LLC. Operates CNC machines to run production per approved schedule provided. Work is performed under close supervision with minimal latitude for the use of initiative and independent judgment.

Ensures complete fulfillment of all replenishment orders. Unloads daily shipment of incoming surgical sets and does the precautionary cleaning of incoming sets. Verifies kind and count of replenishments prior to shipping. Processes and stages outgoing replenishments. Performs the last check of replenishments and surgical sets prior to final boxing for shipment

Performs the formulation and dispensing of pharmaceutical products according to current Good Manufacturing Practices (cGMPs) and utilizing Standard Operating Procedures (SOPs) in a clean room environment. Formulate and dispense product in a clean room environment for Radio-pharm as well as dermatological products. Wash and sterilize all equipment, tubing, filters, stoppers, vessels, vials, ampoules etc.

Perform high-throughput biophysical and biochemical assays to evaluate developability properties of antibody-based molecules. Perform routine cell-culture maintenance, protein expression in mammalian cells and purification in milligram-scale protein production and characterize antigen:antibody (Fab) complexes for crystallization screens.

Perform various manufacturing tasks such as operating, troubleshooting, sterilizing, maintaining, preparing, and cleaning of various process equipment such as stirred-tank bioreactors, media/buffer solutions, disc stack centrifuges, homogenizer, pelletizer, dryer, TFF skid, chromatography systems, parts washers, and CIP systems, under the guidelines of established SOPs and cGMP regulations. Reliably and consistently execute well defined SOPs and batch records. Accurately document data and complete batch records.

Work as part of a cross-functional project team responsible for the delivery of Interactive Response Technology (IRT) for randomization and drug supply management in clinical trials. Support the Services Delivery project team in:Liaising with the client to discuss requirements, handle issues, provide status updates, and answer questions. Designing the IRT solution to meet the study requirements based on the clinical protocol, Suvoda proposal and discussions with the client

Manage and monitor quality assurance activities, such as the review and approval of QMS documents, investigation of issues and execution of CAPAs, preparation and conduct of audits, training management and the qualification of 3rd party vendors. Perform issue trending and work with the organization to improve processes to prevent issues from occurring during the development of products and delivery of services

Plan experiments with guidance from supervisor. Perform complex and critical laboratory experiments (primarily ELISA) with accuracy and precision. Analyze experiment results and recommend potential follow-on experiments.

Maintain a high level of knowledge and understanding of assigned protocols, including all protocol requirements for patient visits, obtaining informed consent, patient visit schedules, test procedures, laboratory information, and drug accountability requirements. Responsible for completion of all study documentation forms, including case report forms and other study specific documents.

Assists the Clinical Research Coordinators in their responsibilities by doing the following: Assists with the basic screening of patients for study enrollment; Assists with patient follow-up visits; Assists the Clinical Research Coordinators with updating and maintaining logs and filing in charts;Perform basic lab procedures, such as: blood specimen collection, centrifuge operation, storing and shipping of lab specimens, accountability of specimens and notification of courier for specimen pick-up,

Assists the Clinical Research Coordinators in their responsibilities by doing the following: Assists with the basic screening of patients for study enrollment; Assists with patient follow-up visits; Assists the Clinical Research Coordinators with updating and maintaining logs and filing in charts;Perform basic lab procedures, such as: blood specimen collection, centrifuge operation, storing and shipping of lab specimens, accountability of specimens and notification of courier for specimen pick-up,

Synthego is looking for a shipping associate to execute our daily order fulfillment activities, ensuring quality and customer satisfaction are top priorities. Coordinate with manufacturing and commercial operations to ensure daily orders are picked, packed, and shipped on-time. Inspect finished product for defects and verify accuracy of order contents and documentation prior to packaging and shipment

This lab-based position will focus on performing high throughput screening assays to support drug discovery for oncology projects. The successful candidate will genetically and chemically interrogate cellular systems, perform and eventually develop cell-based screening assays to support discovery and development of small molecule oncology drug candidates. This individual will have the opportunity to learn and master various cutting-edge techniques including FACS, high-content imaging, Meso Scale Discovery (MSD) etc. to support programs as they progress and should be an enthusiastic learner with the ability to pick up things quickly without repeated training.

We are seeking an experienced software quality engineer who is excited about the work we do at T2 and will work as part of our Engineering team to verify, validate and release software updates, in compliance with our Quality System. This position reports to the Director of Software Engineering and is based in Lexington, MA. The ideal candidate will have strong organizational and communication skills (verbal and written), a meticulous, detail-oriented work approach and be comfortable following a regulated, formal development and release process. 

You’ll use your attention to detail to screen new and repeat donors and take and record donor vital signs and finger stick results. You will use our Donor Information System, prepare donor charts, maintain accurate records, and coordinate donor compensation. You’ll work in our fast-paced, team environment; ensure a clean and professional work environment; attend team meetings; work closely with your management team; and problem-solve together. The high-quality plasma you collect will become life-changing medicines. Here, a commitment to customer service and quality is expected.

The Production Associate (PA) is responsible for executing all processes in production at Takeda’s manufacturing facility in Round Lake, Illinois, while strictly adhering to cGMP, environmental health and safety guidelines and any other related regulations which could apply; fully participates in both departmental projects and any quality working teams which may be applicable; under the general direction of the lead technician and the overall direction of the supervisor, responsible for the hands-on execution of all activities in the production area

The candidate will join the Assay Development group in the R&D division where focus is on molecular assays development such as nucleic acid isolation, purification, amplification and labeling technologies. Work with senior scientists and run hands-on experiments for microbiology, sample preparation, nucleic acid extraction and amplification. Perform detailed data analysis of experiments using Minitab or similar tools and develop summaries for the Assay Development group.

The Research Associate will perform analytical tests using HPLC, Spectrophotometry (RP, IEX, SEC, HILIC etc.), CE, mass with high quality and efficiency; provides analytical support in R&D settings for samples from various process scales; writes experiment summaries and development reports; and assists during document review comprising of but not limited to: batch records, standard operating procedures and assay protocols.

Provide statistical support for study design, data transfer, analysis, verification, interpretation of results in clinical trials. Program datasets used for analysis according to CDISC standard, along with data define documentation and data reviewer’s guide. Create and verify listings/tables/figures based on data collected in clinical trials. Work closely with data management, clinical and regulatory departments.

TE Connectivity’s Software Systems Engineering Teams provide functional and empirical analysis related to the design, development, and implementation of software operating/automation systems, including, but not limited to, utility, development, and diagnostic software. They perform technical planning, system integration, verification and validation, cost, risk, supportability and effectiveness analyses for total systems.

General setup, operation and maintenance of PTFE extrusion equipment and tooling to support manufacturing and development efforts in a clean room environment. Facility cleaning, shipping & receiving, QA support as needed, Customer Service support as needed. Overall a multi-functional individual that will wear several hats during our growth needs.

The Photo Etch Operator is responsible for processing metal parts in small batches through various chemical baths and rinsing tanks in compliance with Tecomet standards. Process metal parts in small batches through various chemical baths and rinsing tanks. Process panels through conveyorized etch systems per given instructions. Perform in-process visual inspection of chemically cleaned and stripped panels.

Perform functions relating to the processing of Topical products (creams, ointments, lotions, solutions) ensuring product compliance to established current Good Manufacturing Practices (cGMPs), customer requirements, and in conjunction with all Standard Operating Procedures (SOPs). Perform functions relating to the cleaning and sanitization of compounding process equipment and compounding facility to facilitate GMP compliance, quality, safety, and schedule attainment. Follow standard operating procedures to complete tasks, some of which may vary in scope, sequence, complexity and timing.

Work in a cutting-edge clinical laboratory to support next-generation sequencing workflow with rapid turnaround times. Utilize state-of-the-art automation and robotics to extract nucleic acids. Track sample progress through the next generation sequencing workflow. Perform basic molecular biology protocols

We are seeking a motivated Research Associate with experience in viral vector analytical methods for our newly formed Technical Operations Analytical Development/Quality Control Group. In this role, you will perform key molecular biology and cell based assays to support Process Development activities; troubleshoot and optimize particular assays as needed; develop new analytical methods to determine the strength, purity and/or potency of viral vector preparations; perform other tasks such as SOP writing, lab maintenance, supply ordering and write-ups of experiments for potential regulatory submissions.

Provide technical support to customers via phone, email or chat utilizing remote access tools provided by TeraRecon. Actively Monitor customer systems for failures/issues and follow-up on those remotely. Analyze and resolve customer service issues associated with TeraRecon products running on Windows Workstations and Windows Server Operating Systems.

ob Details: 1. Assemble prototype products per design specifications, drawing and/or engineering direction. 2. Assemble parts by using small instruments with or without a microscope, and through the operations of automated/semi-automated equipment. 3. Troubleshoot and suggest creative solutions to design and process issues.

Job Summary: This entry level engineering position is responsible for providing engineering support to Terumo Interventional Systems (TIS) new product development activities as defined in Terumo Medical Corporation (TMC) QA101 Product Development Process & Design Controls under the direction and oversight of senior engineering personnel. Key activities may include: collection of voice of customer (VOC) data; development of concepts for feasibility analysis; development of product specifications; new product design, development, verification and validation; preparation of design control documentation; risk management studies and analyses; process development and prototype fabrication; and support of commercialization activities.

This position is an entry level position in the Facilities Engineering department. Associate will be expected to perform maintenance on equipment and plant facilities to ensure functional accuracy and completeness, under the guidance and direction of Senior / Lead Facilities Engineers.

Teva is searching for an experienced Neuro / Psych Sales Representative to join our team in the Tacoma, WA area! As a Sales Representative you will establish and maintain professional relationships with targeted physician groups to maximize new business opportunities. Build rapport and relationships by interacting effectively with employees and external contacts (i.e. HCP and office staff) at all levels, demonstrating the awareness of their needs and responding with the appropriate action. Provide healthcare product demonstrations, physician detailing and in-servicing of products to current and potential customers.

Teva is searching for an experienced Neuro / Psych Sales Representative to join our team in the Tacoma, WA area! As a Sales Representative you will establish and maintain professional relationships with targeted physician groups to maximize new business opportunities. Build rapport and relationships by interacting effectively with employees and external contacts (i.e. HCP and office staff) at all levels, demonstrating the awareness of their needs and responding with the appropriate action. Provide healthcare product demonstrations, physician detailing and in-servicing of products to current and potential customers.

Teva is searching for an experienced Neuro / Psych Sales Representative to join our team in the Tacoma, WA area! As a Sales Representative you will establish and maintain professional relationships with targeted physician groups to maximize new business opportunities. Build rapport and relationships by interacting effectively with employees and external contacts (i.e. HCP and office staff) at all levels, demonstrating the awareness of their needs and responding with the appropriate action. Provide healthcare product demonstrations, physician detailing and in-servicing of products to current and potential customers.

Utilizes radio frequency (RF) system and operates fork-lift to receive and put-away inbound (IB) receipts - includes physically breaking down and creating optimal sized pallets prior to put-away into inventory. Utilizes RF system and operates fork-lift to move inventory throughout the warehouse for the purpose of managing inventory and replenishing picking locations. Performs tote picks via tote management system (Pick-to-light module) - includes deployment of totes on PTL module, using PTL module to accurately pick orders from shelf to tote

Is an expert at identifying sources and searching for relevant information. Retrieves, researches, and compiles data to support client projects. Conducts analysis of scientific data and regulatory information. Summarizes regulatory information and pertinent scientific literature for assigned projects.

This individual will join a multi-disciplinary team to develop, automate and conduct biochemical and cell-based assays to help drive lead optimization and obtain mechanistic insights for all research programs. Will play a key role in developing, optimizing, and automating new assays. Will conduct compound screening for SAR support and perform quality data analysis.

Pick, pack, sort, arrange, count, store, and correctly process items for storage and/or shipment in accordance with established procedures and customer requirements while sustaining a high level of quality to ensure customers receive correct product and in the time requested. Receive materials and/or finished goods on a daily basis. Verify the quality, type and amount of materials received are correct and that the appropriate documentation is present (e.g. packing list).

Under the direction of the Engineering Manager, with a dotted line to the Shift Supervisor, this position is responsible for installing and removing molds and related auxiliary equipment and components from the molding press as well as preparation of setup for appropriate machines as defined. This individual is also responsible to make necessary adjustments to equipment to ensure quality and quantity of production for the assigned area.

The candidate will be responsible for the performance of operations in support of the manufacture of Commercial and Clinical Biologics. He/She will be responsible for following Current Good Manufacturing Practices (cGMPs) and carrying out a variety of functions related to Upstream (cell culture) biopharmaceutical manufacturing, with a primary focus on Harvest and Media Preparation.

The Quality Assurance Associate I is responsible for the inspection, testing, record keeping and overall quality assurance support to manufacturing. Follow procedures to determine status or disposition, and properly document results on records and in lab notebooks.Inspect material, components, and finished product against specified requirements.

The Aseptic Operator I performs routine activities related to supporting the injectable team, while ensuring that products are made with quality for our patients. Perform job responsibilities in accordance with standard operating procedures (SOPs) and production records with an expectation of "Right the First Time". Assist in setup and manufacture (bulk, fill, stopper, label, and package) clinical supplies and commercial pharmaceutical products in an aseptic environment in accordance with production batch records.

Toxikon is currently seeking a full-time Histology Research Associate. Qualified candidates should be a team player, have a willingness to learn, be detail oriented, proficiency with computers and have well-developed time management skills. Trimming of tissues and organs harvested at necropsy. Embedding and processing of tissues. Microtomy Routine H&E staining, other stains as required. Maintain and/or create GLP documentation as necessary, including relative SOPs and histology records, Maintain wet tissue archive.

In this quality assurance role, the appropriate candidate will be responsible for the implementation, functioning, and monitoring of quality assurance activities. This includes monitoring biological and chemical studies, and creating reports in conformance with GLP practices. Candidates will review GMP, GLP and non-GLP reports for accuracy with reference to protocols, Quality Assurance Standards, Standard Operational Procedures, laboratory precision and accuracy limits, as well as reviewing all protocols for compliance and accuracy.

We are seeking a self-motivated and quality focused individual to join our Extraction team as a Lab Assistant. This position will be responsible for preparing medical devices by extraction using common vehicles and solvents for pre-clinical safety testing. Routine mathematic principles, such as surface area calculations, are required to be able to prepare medical devices and create the required dose solutions.

The Packaging Specialist is responsible for operating and maintaining the equipment on their respective shift and support of the overall department’s performance goals. They are responsible for the completion of operations on a daily basis. This includes meeting the daily packaging output goals, following the procedures as defined by SOP’s, and executing specific verbal directions from their direct leadership. The Packaging Specialist is responsible for maintaining and ensuring their training is complete. Each Specialist is hired into a minimum level that they are required to attain.