Links to 1604 Entry-Level Biotechnology & Life Science Jobs

We are seeking an outstanding Research Associate to join the Product Development group to support the development and commercial launch of new products. This is a unique cross-disciplinary position that will work closely with a variety of groups including Molecular Biology, Chemistry, Microfluidics, QC, and Manufacturing, to develop and validate novel reagents for the rapid expansion of 10x product lines. Candidates must have a broad working knowledge of molecular biology and be able to apply that knowledge creatively and independently in a fast-paced work environment. The successful applicant will have exceptional attention to detail and the ability to meticulously execute and analyze highly complex experiments. Previous industry experience is essential. etc.

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

Your Typical Responsibilities: Protein engineering to support TCR-T cell programs, and identify compounds with optimal therapeutic index. TCR engineering for improved efficacy, and specificity. Performing cell-based assays to test prospective optimized leads. Discovery of TCR mimetic (mTCR) compounds that bind selectively to pMHC targets identified at 3T. Improvement of existing yeast display platforms and development of next-generation pMHC libraries. etc.

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

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

This position is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, or system/services support. Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements. Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements

Briefly state the main purpose and scope of the job. Working under close supervision, may perform a combination of assembly, weld, x-ray, repair, and test operations on pacemakers, implantable cardioverter defibrillators (ICDs), leads, and related medical device assemblies. Performs routine assignments according to specified and/or standardized procedures. Work is closely and continually reviewed.

Responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs. Support and ensures the proper prediction of, and the ultimate product performance of the electrical system. Support on-time execution of Quality Plans for internal development, OEM-based and design change projects. Evaluates product design to identify potential design issues and drive technical decisions

The Pharmacy Technician position exists to support the pharmacist(s) in completing the duties associated with entering and managing drug therapy orders, fulfilling, and dispensing prescriptions, maintaining pharmacy records and other professional activities. This position is responsible for collaborating with and supporting Pharmacy Leads and Supervisors in day to day activities, issue resolution, and completion of project tasks. Responsibilities: Assist the pharmacist with practice of pharmacy in accordance with federal, state and local regulations, HIPAA guidelines, corporate and departmental policies and procedures. Assist pharmacists in the picking, labeling, packing and shipping of orders; by accurately interpreting healthcare provider’s prescription orders and entering it into the core pharmacy system; etc.

This position will serve as a liaison between the Process Research and Development scientific functions and the API Pilot Plant organization. The successful candidate will assist in the optimization and scale-up of synthetic processes and facilitate the implementation of the processes and new technologies in to the API Pilot Plant. The Scientist will also provide technical oversight during production campaigns and will support technical transfer to the ultimate commercial manufacturing site.

We are seeking a Research Associate for our Quality Control team to test a wide variety of antibody-based products in our Eugene, OR facility. The core responsibility will be to provide support to the quality control team by testing our catalog of products after they have completed the manufacturing process. These products include quantity ELISA kits, activity ELISA kits, Western blot antibodies, immunocytochemistry antibodies, and flow cytometry kits. Primary Responsibilities: Perform documented methods required for finished product quality testing. Review manufacturing documentation for process deviations. Communicate analyzed results in detailed written reports. etc.

Perform mammalian cell culture including adherent, suspension cell lines and primary cells. Assist in developing and optimizing the protocols for cell based functional assays which includes potency assays and immunoassays. Clearly document experiments and procedures in laboratory notebooks, analyzing and presenting experimental data within internal team meetings.

Perform cell engineering using CRISPR technology for service type cell-based projects. Generate and maintain modified cancer, iPSC and other cell lines in BSL-2 level laboratory environments. Generate high-quality and deliverable data, perform data analysis and report in a timely, troubleshooting wherever needed; Collaborate and exchange the technique protocols, tips and experience with other team members internally or externally

We are seeking a Research Associate for a technology development opportunity at Abcam, a leading life science company, in our Cambridge, US office. This position will work within an exciting multi-disciplinary team of scientists and engineers to develop new research tools for use by life scientists worldwide. The Research Associate will be responsible for developing multiplex immunoassays utilizing the FirePlex particle technology. The candidate will support the production and quality control of the FirePlex immunoassay kits. The ideal candidate will be an experienced research scientist that performs well-designed experiments and has a passion for developing technologies to enhance life science research. etc.

We are seeking a Research Associate to assist in the development of novel homogenous immunoassays in our Eugene, OR facility. The core responsibility will be to provide support to the homogenous immunoassay development team through the use of antibody-based laboratory techniques such as sandwich ELISA, Western blot and flow cytometry as well as the generation of biological materials for analysis. etc.

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

The Custom Services Department is responsible for the development of best in class antibodies using wide variety of antibody discovery pipelines and extensive suit of antibody characterization assays. Execute experiments under direction of supervisorWork as part of the team to implement experimental plans support data management: ensure the recording and analysis of all processed data in a timely manner, with appropriate population of laboratory notebooks and data management systems

Following the acquisition of gene editing platform and oncology product portfolio of Applied StemCell Inc, we are now looking to expand the team as we look to become a leader in the cell engineering field. With this in mind, we are recruiting for a Research Associate to join our Cell Engineering team. Perform cell engineering using CRISPR technology for service type cell-based projects. Generate and maintain modified cancer, iPSC and other cell lines in BSL-2 level laboratory environments

The Mechanical Designer works under the direction of the Design Team Leader and also utilize independent judgment to perform the day-to-day project duties of designing, developing and releasing deliverables. This includes detail & assembly drawings and related bills-of material used in the fabrication of equipment for pilot and commercial scale biopharmaceutical manufacturing (largely pressure vessel assemblies for fluid & gas handling and motorized agitation systems). Primary responsibility involves generating design plans utilizing Autodesk Inventor and AutoCAD software. This position requires a high level of attention to detail along with the ability to develop a strong understanding of the ASME/ BPE Bioprocessing Equipment design standards. etc.

Abeona is looking for a Quality Control Associate to join our team in Cleveland, OH. The successful candidate is a key part of our growing QC Team and will be primarily responsible for performing routine laboratory activities in support of GMP testing for Quality Control. Testing includes raw material, packaging components, environmental monitoring, in-process and finished product. Interacts with employees internal and external to Quality Control.

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

Absorption Systems, provides analytical support for gene and cell therapy products through every stage of development, is seeking a candidate for either an Associate Scientist position in molecular biology and gene expression at the headquarter location in Exton, Pennsylvania. Absorption Systems also provides non-clinical testing services to pharmaceutical and biotech companies to support research and development of drugs, biologics, and medical devices. Primary Responsibilities: Preparation for protocol of assay, planning and conducting experiments under the direction of a senior scientist. Conducting studies on molecular biology assays, such as purification of DNA/RNA/Protein from samples, qPCR, protein assays. etc.

Provides maintenance of laboratory equipment. Maintains proper laboratory cleanliness and organization. Operates to the highest ethical and moral standards. Complies with Abzena’s policies and procedures.Adheres to all safety standards and protocols.

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.

Plan, execute and interpret experiments; Analyze data, evaluate results, form conclusions, and recommend future experiments; Ensure accurate and consistent recording of experiment methods, materials and results; keep a high-quality laboratory notebook; Communicate and work efficiently with other groups within R&D team;

The Production Technician is responsible for producing and testing components by assembling parts and subassemblies in manufacturing that will allow Accuray to provide products that meet customer needs and in accordance with regulatory requirements. Prepares work to be accomplished by gathering parts, subassemblies, tools, and materials required per job order. Assembles components per work instructions and tests product as required using test equipment and fixtures.

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

We are currently hiring a field-based Specialty Pharmaceutical Sales Representative who will be able to drive branded prescription sales in their assigned territory. The Specialty Pharmaceutical Sales Representative will promote our growing portfolio of innovative, branded prescription pharmaceutical and dietary supplement products in Women’s Health, Hematology, Dermatology, and related specialties. The primary call point will be OB-GYN & Rheumatology offices in their territory, calling on assigned healthcare providers, informing those providers on the features and benefits of our products to effectively grow our market share. Develop and maintain an in-depth knowledge of our products that enables the Pharmaceutical Sales Representative to engage in meaningful dialogue when calling on healthcare providers. Responsible for providing healthcare providers with all relevant information that promotes quality healthcare decisions. Employ effective selling techniques, including pre-call planning, effective opening, presentation focus, productive questions, issues identification and effective close. etc.

The Sales Associate (SA) exceeds sales quota within an assigned territory by driving the market acceptance and adoption of Acumed products. S/he converts key surgeons to Acumed's products by utilizing a high level of technical and surgical knowledge. S/he focuses on developing relationships, listens to customer needs, and provides product solutions and services that exceed customer expectations. The SA provides technical advice to customers to ensure optimum use of our products to maximize surgeon satisfaction and patient outcomes. Continuously assesses the customer base to identify new business opportunities and develops a targeted sales strategy for each identified opportunity proactively ensuring all leads are followed up on appropriately. etc.

The Associate Sales Representative (ASR) exceeds sales quota within an assigned territory by delivering Acumed product on time and providing high quality technical assistance in the OR. The ASR assists in the assessment of the customer base to identify new business opportunities and executes a targeted sales strategy for each identified opportunity proactively ensuring all leads are followed up on appropriately. Duties/Responsibilities: Execute business plans to identify and close new business. Identifies the needs of new prospects and develops/delivers appropriate responses to meet or exceed needs (written, telephone and face-to-face). etc.

The Sales Associate (SA) exceeds sales quota within an assigned territory by driving the market acceptance and adoption of Acumed products. S/he converts key surgeons to Acumed's products by utilizing a high level of technical and surgical knowledge. S/he focuses on developing relationships, listens to customer needs, and provides product solutions and services that exceed customer expectations. The SA provides technical advice to customers to ensure optimum use of our products to maximize surgeon satisfaction and patient outcomes. etc.

The Sales Associate (SA) exceeds sales quota within an assigned territory by driving the market acceptance and adoption of Acumed products. S/he converts key surgeons to Acumed's products by utilizing a high level of technical and surgical knowledge. S/he focuses on developing relationships, listens to customer needs, and provides product solutions and services that exceed customer expectations. The SA provides technical advice to customers to ensure optimum use of our products to maximize surgeon satisfaction and patient outcomes. etc.

The User Interface Designer/Researcher conducts iterative design activities to help build best-in-class customer experiences across all Acutus hardware and software platforms and touchpoints. The UX Designer/Researcher is responsible for driving the user experience across a wide array of projects. This role collaborates with customers, product managers, software/system design leads, and various engineering leads to ensure the design deliverables successfully and efficiently move each feature from concept to final product.

The User Interface Designer/Researcher conducts iterative design activities to help build best-in-class customer experiences across all Acutus hardware and software platforms and touchpoints. The UX Designer/Researcher is responsible for driving the user experience across a wide array of projects. This role collaborates with customers, product managers, software/system design leads, and various engineering leads to ensure the design deliverables successfully and efficiently move each feature from concept to final product.

This Quality Assurance Associate (Deviations & CAPA) role is for an individual, with entry to intermediate level experience in QA discipline, who will be responsible for the initiation, investigation of process deviations aimed at identification of root cause, and implementation of correct actions to prevent recurrence. This role is expected to work in a Good Manufacturing Practices (cGMP) environment, have some level of working knowledge of manufacturing processes, a professional and expert technical writing capability, be action oriented, and be compliant minded while performing and reviewing investigations and CAPA. This position reports directly to the QA Manager with dotted line reporting to QA Senior Specialist. etc.

Performs cell manufacturing related activities while wearing clean room attire in an aseptic cGMP manner. Documents production operations in corresponding batch records and log books per established procedures ensuring accuracy and timely completion. Identifies real time manufacturing issues (deviations and atypical results) and communicates them to the Manufacturing Manager and the Quality team in a timely manner. Inputting and uploading of manufacturing data in real time to existing database.

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

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

Adaptive Biotechnologies is looking for an outstanding employee to join its Supply Chain team. Responsible for managing the receipt, storage, and distribution of laboratory components and business supplies, Material Handlers at Adaptive perform the key function of keeping our operations running. More than a run-of-the-mill warehouse associate, successful candidates will need to demonstrate meticulous attention to detail and strict adherence to standard operating procedures. The position will work directly with the Procurement, Production, and Finance departments to accurately track, record, and maintain the right amount of raw materials and supplies where they’re needed. etc.

The Research Assistant will perform regular upkeep and maintenance of lab equipment and reagents for the R&D labs at Adaptive. They will work with people across multiple departments, including the environmental health and safety officer, facilities & equipment specialist, and material handling team, in addition to closely working with the multiple teams within MRI and Molecular Product Development, to create a safe and well-prepared lab environment.

The BSM Specialist II position will join the Biological Sample Management (BSM) group at Adaptive Biotechnology’s Seattle laboratory. The primary function of this role is to support sample management and chain of custody for Adaptive’s immunosequencing services that includes research, clinical projects, and diagnostic testing. Primary responsibility is to receive and accession samples into the Laboratory Information System (LIMS) used by BSM AND/OR perform sample discards and returns per standard retention times, or by request.

Adaptive is seeking a research associate I with an aptitude for learning to join our dynamic and collaborative R&D team. You will partner with other researchers and computational biologists in the development of new and optimization of existing assays for transition into a service lab and/or kit. Work in tandem with team to develop PCR-based assays for immune system profiling by next generation sequencing. DNA/RNA extraction from large number of samples.

The Research Assistant will perform regular upkeep and maintenance of lab equipment and reagents for the R&D labs at Adaptive. They will work with people across multiple departments, including the environmental health and safety officer, facilities & equipment specialist, and material handling team, in addition to closely working with the multiple teams within MRI and Molecular Product Development, to create a safe and well-prepared lab environment.

The BSM Specialist II position will join the Biological Sample Management (BSM) group at Adaptive Biotechnology’s Seattle laboratory. The primary function of this role is to support sample management and chain of custody for Adaptive’s immunosequencing services that includes research, clinical projects, and diagnostic testing. Primary responsibility is to receive and accession samples into the Laboratory Information System (LIMS) used by BSM AND/OR perform sample discards and returns per standard retention times, or by request.

Adaptive is seeking a research associate I with an aptitude for learning to join our dynamic and collaborative R&D team. You will partner with other researchers and computational biologists in the development of new and optimization of existing assays for transition into a service lab and/or kit. Work in tandem with team to develop PCR-based assays for immune system profiling by next generation sequencing. DNA/RNA extraction from large number of samples.

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

This is an entry level position at Adare Pharmaceuticals, Inc. (Adare) and the skills learned during training will enable the new operator to perform essential job functions. The essential job function are to produce specified products by the mixing, blending, and combining of raw materials as specified by written procedures. This position is night shift working 12 hours shifts on a 2-2-3 schedule, for example working Monday and Tuesday off Wednesday and Thursday and working Friday, Saturday and Sunday then off Monday and Tuesday.

Provide diverse regulatory support to the Regulatory Affairs Department as outlined in essential duties and responsibilities below. Assesses change control documentation and technical documents for incorporation of the information into regulatory submissions. Prepares regulatory submissions for annual reports and assists as necessary with preparation of new regulatory submissions and amendments. Demonstrates an understanding of health authority reporting obligations throughout annual report preparation and seeks guidance when needed to address complex changes.

Responsibilities will broadly include supporting the development of new biomarker assays with Adarza’s proprietary AIR™ technology on the ZIVA platform. You will work as part of a team utilizing your laboratory skills to develop and validate immunoassays, as well as provide routine analysis of biological samples for early access clients. The successful candidate will be responsible for reagent preparation, specimen processing, developing and running AIR™ assays. Candidates will be asked to communicate previous work experience successes during the interview process to demonstrate their abilities and the relevance of their experience

Responsibilities will broadly include supporting the development of new biomarker assays with Adarza’s proprietary AIR™ technology on the ZIVA platform. You will work as part of a team utilizing your laboratory skills to develop and validate immunoassays, as well as provide routine analysis of biological samples for early access clients. The successful candidate will be responsible for reagent preparation, specimen processing, developing and running AIR™ assays. Candidates will be asked to communicate previous work experience successes during the interview process to demonstrate their abilities and the relevance of their experience

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

The Document Assistant will Create, format, revise and proof read controlled documents such as Standard Operating Procedures (SOPs), Forms, Validations, etc. from departments including but not limited to Quality Assurance, Manufacturing, Facilities, and Quality Control. Perform general office duties such as photocopying, word processing, filing, scanning, physical inventory, ordering supplies.

The Chemist I will Perform quality control testing of raw materials, in-process and final products; following general instructions on routine work and detailed instructions on new assignments. Perform quality control chemistry and/or Immunoassays for raw materials, in-process and final products according to approved Standard Operating Procedures (SOP’s). Perform instument calibration or qualification according to written procedures.

The Document Assistant will Create, format, revise and proof read controlled documents such as Standard Operating Procedures (SOPs), Forms, Validations, etc. from departments including but not limited to Quality Assurance, Manufacturing, Facilities, and Quality Control. Perform general office duties such as photocopying, word processing, filing, scanning, physical inventory, ordering supplies.

The Chemist I will Perform quality control testing of raw materials, in-process and final products; following general instructions on routine work and detailed instructions on new assignments. Perform quality control chemistry and/or Immunoassays for raw materials, in-process and final products according to approved Standard Operating Procedures (SOP’s). Perform instument calibration or qualification according to written procedures.

The Specialist I-Quality Assurance-Product Release will Performs a wide variety of Quality Assurance activities to ensure compliance with related regulatory requirements. Main focus on review of batch records and associated documents for product release. Responsibilities: Perform review and support release of manufacturing batch records (in-house and CMO batches) along with all manufacturing supporting documents including but not limited to logs, charts, specifications, and environmental and WFI data. Perform review and release of all Plasma pools, both for internal use and shipment to customers as required. etc.

The Plasma Operations Supply Chain Specialist will support all Plasma Operation activities, from plasma shipments from approved donation centers to off-site warehousing through to the Boca manufacturing facility. They will also support plasma lookback process for all plasma programs and the Donor Management process, including sample testing in support of RI-002, Nabi-HB and client programs. Assist with vendor relationships with off-site testing labs and off-site plasma warehouse. Document physical supply chain processes, such as plasma shipments, lookbacks and plasma inventory reconciliation. etc.

We currently have an opportunity available for a Materials Technician centrally located in Boca Raton, FL! Responsibilities: Receive, store and distribute raw materials, intermediate and marketed products in compliance with GMP and company standards. Maintain and order inventory of supplies. Will be working in a cold room environment. etc.

Responsibilities: Preparing solutions and reagents for performing assays on the bench. Perform Next Generation Sequencing-based genomic assays on different workflows (few listed below): RNAseq, Whole Genome Sequencing, Whole Exome Sequencing. Carry out genomic assays under Biosafety Level II Policies and in regulatory compliance. Perform Operational Qualification and Performance Qualification on Next Generation Sequencers. Strictly follow standard operating procedures set forth for processing biological specimens while complying with laboratory safety protocols. Strict record keeping of all laboratory procedures. etc.

Relay standard information on next generation sequencing applications to customers. Standard communication with prospective, current, and past customers. Co-coordinating multiple genomic projects with excellent documentation skills and communication to customers. Materials purchasing support for laboratory team

Relay standard information on next generation sequencing applications to customers. Standard communication with prospective, current, and past customers. Co-coordinating multiple genomic projects with excellent documentation skills and communication to customers. Materials purchasing support for laboratory team

This position is responsible for the timely and accurate processing of payroll and maintaining payroll records; timely and accurate processing and payment of Accounts Payable and maintaining AP records; timely and accurate processing of General Ledger journal entries and Balance Sheet account reconciliations; Assist in month end close process. MAJOR DUTIES OF POSITION: Process biweekly payroll and maintain all payroll records. Prepare periodic reports of earnings, taxes and deductions. Keep record of leave pay (sick, vacations, disability). Prepare and transmits 401K spreadsheets. Prepare and uploads 125K spreadsheets. etc.

Responsibilities: Essential Duties: Assists supervisor to ensure that production operators have sufficient stock of materials. Collects, checks and keeps records of materials flow to and from production area. The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time. etc.

Responsibilities: Essential Duties: Performs repetitive and routine inspections, checks, tests and sampling procedures of standard parts, units, equipment or materials. Performs inspections of purchased parts, subassemblies or finished company products according to well defined criteria using standard physical, mechanical and/or electrical measurements. Reworks or rejects subassemblies or finished products as required. Performs audits to ensure standards of quality are maintained. etc.

Works under the direction of the Supervisor/Lead Processing Technician/Setup Technician. Using specific methods, inspects plastic molded parts for visual dimensional defects; performs light to medium packaging and product handling functions. Completes documents required to release parts. Performs cleanup of equipment and facilities in the Injection Mold production areas. Attends injection molding machine and subassembly equipment. Does minor trouble-shooting not requiring a maintenance mechanic or process technician (i.e. Lead Processing Technician, Setup Technician, Process Technician). etc.

Responsibilities: Essential Duties: Follows established procedures and guidelines to manufacture the organizations products according to specifications and schedules, volume, cost and waste targets, or quality standards. Operates machines and production equipment safely and in accordance with instructions. Monitors the quality of output to identify, discard or remanufacture products. Troubleshoots problems by contributing to team with input, feedback and/or ideas for improvement. etc.

The Process Transfer Technical Writer is a role for individuals with a STEM background that provides the opportunity to learn and support biotechnology manufacturing operations. Working under the direction of departmental staff, individuals in this role take part in generating key manufacturing documentation, resolving technical issues, and providing training to manufacturing operators. Generating process instructions and batch records from pre-established templates, using source data and information provided, and as instructed and guided by Process Transfer Staff

The Manufacturing Associate performs GMP manufacturing operations safely, reliably and in compliance with stated processes. 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

Input vendor invoices into the system in a timely and accurate manner (including 2 way/3 way match). Assist in the preparation of the weekly check runs. Oversee the maintenance of our expense reporting tool (Acubiz) including user maintenance, recording expenses in the GL, and expense report approvals. Ensure all invoices/payments are properly filed

The Process Transfer Technical Writer is a role for individuals with a STEM background that provides the opportunity to learn and support biotechnology manufacturing operations. Working under the direction of departmental staff, individuals in this role take part in generating key manufacturing documentation, resolving technical issues, and providing training to manufacturing operators. Generating process instructions and batch records from pre-established templates, using source data and information provided, and as instructed and guided by Process Transfer Staff

The Manufacturing Associate performs GMP manufacturing operations safely, reliably and in compliance with stated processes. 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

Input vendor invoices into the system in a timely and accurate manner (including 2 way/3 way match). Assist in the preparation of the weekly check runs. Oversee the maintenance of our expense reporting tool (Acubiz) including user maintenance, recording expenses in the GL, and expense report approvals. Ensure all invoices/payments are properly filed

This is a Development Associates position in the Upstream Process Development group. Primary responsibility will be to support mammalian cell culture processes used for the manufacture of therapeutic recombinant proteins. The successful candidate will be responsible for supporting shake flask and bioreactor experiments, sampling, inoculating, feeding & harvesting bioreactors. Under general supervision, this person carries out routine to moderately complex experiments or procedures. PRINCIPAL RESPONSIBILITIES: Maintain lab including cleaning, autoclaving reactors, stocking laboratory supplies and performing maintenance on laboratory equipment. etc.

The Business Process Associate role reports into the Global Sales Enablement (GSE) team, which supports LSS Global Sales and Marketing functions. This team collaborates cross-functionally with sales, marketing, service, SUs and other supporting organizations, to effectively execute strategic LSS and Corporate programs across the world. We're looking for a talented and motivated professional to join the team. Responsibilities include: Responsible for analysis and evaluation of user business problems and development of business system or process recommendations to meet requirements, including problem definition, evaluation of requirements, and implementation of systems/processes. etc.

The Electronics Technician I position is required to support the manufacture of GCMS instruments. This position will be responsible for testing, troubleshooting, and reworking instruments within the flow of the GCMS production lines. This role involves working with electronic assemblies in support of shipment of instruments and support parts to meet customer needs. This position works closely with R&D development engineers on NPI products and value engineering improvements. etc.

The Quality Assurance (QA) Specialist provides quality oversight of internal and external activities, documentation and processes to assure compliance with company procedures and FDA regulations and assists with tasks necessary to achieve departmental and company goals. Support the development, implementation, and improvement of corporate quality systems that support early, mid and late phase gene therapy clinical programs. Increase compliance awareness and promote a culture of quality throughout the company, with a focus on laboratory and manufacturing operations

The Quality Assurance (QA) Specialist provides quality oversight of internal and external activities, documentation and processes to assure compliance with company procedures and FDA regulations and assists with tasks necessary to achieve departmental and company goals. Support the development, implementation, and improvement of corporate quality systems that support early, mid and late phase gene therapy clinical programs. Increase compliance awareness and promote a culture of quality throughout the company, with a focus on laboratory and manufacturing operations

Reporting to the Manager of Clinical Research Associates, the person in this role is responsible for the management of day-to-day aspects of investigational site activities on assigned clinical trials. The CRA should ensure compliance with international guidelines, local regulations and corporate policies and procedures. Conduct reviews of documentation needed for internal and external audits to ensure all essential clinical Trial Master File (TMF) documents are compliant with Good Documentation Practices, Abiomed internal SOPs, and US and OUS regulations

The Drug Product Manufacturing Assistant is responsible for implementation of routine production and manufacturing procedures to optimize processes and regulatory requirements. Performs various routine manufacturing tasks under the guidelines of established SOP’s and cGMP regulations. Implements production and manufacturing procedures. Performs visual inspection.

The facilities assistant is responsible for general maintenance of facility areas including office, conference room, and utility areas. The position provides general support including cleaning, painting, uncrating and assembly, and ordering and stocking of facility supplies, spare parts, and equipment. Maintain facility in a presentation-ready, clean state. Assist with maintenance activities as overseen by a senior member.

The Aseptic Cleaning Assistant performs tasks of the production operation specific to aseptic cleaning and sterilization of processing equipment, parts and rooms. The Assistant maintains batch record documentation and logs as required by corporation and regulatory agencies. This role prepares, according to procedures, various stock solutions and buffers as required by the production process. In addition, this position is responsible for operating general production equipment (such as autoclaves).

We are looking for multiple Drug Product Manufacturing Assistants for 1st Shift! The Drug Product Manufacturing Assistant is responsible for implementation of routine production and manufacturing procedures to optimize processes and regulatory requirements. Responsibilities: Performs various routine manufacturing tasks under the guidelines of established SOP’s and cGMP regulations. Implements production and manufacturing procedures. Performs visual inspection. Prepares components, media, buffers, and other solutions as needed. Accurately documents data and completes batch records as needed. May cross train and/or focus in various manufacturing tasks including fill/finish, formulation, fermentation, preparation. Operates production equipment and may prepare buffers and media, inspect, label, or box. etc.

Ajinomoto Bio-Pharma Services is currently seeking a MQA Assistant to support our manufacturing. The MQA Assistant ensures completeness and accuracy of information contained in all documents, document files, databases, and documentation systems. This individual has the ability to work independently, within prescribed guidelines, and as a team member. This position promotes a cGMP environment and follows SOPs. Responsibilities: Performs cGMP documentation/data review in support of manufacturing operations (e.g. logbooks, labels, etc.). Performs AQL inspection of final filled product. etc.

This individual is a Research Associate who will work with a team of research associates and scientist at AKESOgen. The Research Associate will work under the general direction of a Team Lead. This individual will perform extractions on a variety of sample types, genotyping on Affymetrix and/or Illumina platform equipment maintenance, solution and reagent preparation in addition to other tasks in laboratory. Operate automated liquid handling platforms for sample processing, DNA/RNA extraction and quantification instruments.

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

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

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

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

All Sanitization Associates are responsible for all activities associated with the manufacturing and filling operations, required to produce sterile drug products under aseptic conditions. Compliance with associated SOPs and training requirements. Removal of used scrubs and coveralls into appropriate bins. Stocking of consumable items, such as bouffant hats and beard covers

The Specialty Dermatology Pharmaceutical Sales Representative is accountable and responsible for her/his territory achieving or surpassing sales goals on a monthly basis. Takes ownership and demonstrates the ability to drive monthly sales results through superior selling skills - meeting and exceeding all performance goals. Proven ability to observe and identify market opportunities and challenges and subsequently develop, plan, implement, and follow through with action plans to positively influence opportunities and challenges.

The Specialty Dermatology Pharmaceutical Sales Representative is accountable and responsible for her/his territory achieving or surpassing sales goals on a monthly basis. Takes ownership and demonstrates the ability to drive monthly sales results through superior selling skills - meeting and exceeding all performance goals. Proven ability to observe and identify market opportunities and challenges and subsequently develop, plan, implement, and follow through with action plans to positively influence opportunities and challenges.

The Specialty Dermatology Pharmaceutical Sales Representative is accountable and responsible for her/his territory achieving or surpassing sales goals on a monthly basis. Takes ownership and demonstrates the ability to drive monthly sales results through superior selling skills - meeting and exceeding all performance goals. Proven ability to observe and identify market opportunities and challenges and subsequently develop, plan, implement, and follow through with action plans to positively influence opportunities and challenges.

The Regulatory Affairs Specialist is accountable for driving results in a fast-paced environment by performing activities to ensure that regulatory submissions support active pharmaceutical ingredient (API) business needs and that the business remains compliant with regulatory filings. Activities include preparation and submission of regulatory filings, written and verbal communication with regulatory agencies and clients, and providing regulatory affairs information and counsel to other site functions. The position requires superior leadership behaviors of the Alcami core competencies and non-negotiables, as well as expertise in functional competencies included in this position profile. Essential Functions: Remain informed about regulations and regulatory trends concerning US FDA and other countries’ regulatory agencies. etc.

The Manufacturing Technician I is accountable for results in a fast-paced environment and assists with the manufacturing of drug products (parenteral or solid dosage) for commercial distribution and clinical trials. The Manufacturing Technician I assists with the operation of manufacturing processing equipment by following standard operating procedures (SOPs) and batch records in accordance with regulatory agencies and current Good Manufacturing Practices (cGMPs). The Manufacturing Technician I employs acceptable techniques while working in manufacturing environments, including PPE gowning. The Manufacturing Technician I works collaboratively to support other manufacturing areas as required. The position requires superior leadership behaviors of the Alcami core competencies and non-negotiables, as well as expertise in functional competencies for the role. etc.

The Materials Control Technician I is accountable for results in a fast-paced environment by following applicable SOPs and cGMPs to perform tasks for the receipt, storage, inventory and distribution of raw materials, intermediate or finished drugs or drug products and components. The Materials Control Technician I uses the electronic inventory system to track, document and control all inventory. The position requires superior leadership behaviors of the Alcami core competencies and non-negotiables, as well as expertise in functional competencies included in this position profile. etc.

The Manufacturing Technician I is accountable for results in a fast-paced environment and assists with the manufacturing of drug products (parenteral or solid dosage) for commercial distribution and clinical trials. The Manufacturing Technician I assists with the operation of manufacturing processing equipment by following standard operating procedures (SOPs) and batch records in accordance with regulatory agencies and current Good Manufacturing Practices (cGMPs). The Manufacturing Technician I employs acceptable techniques while working in manufacturing environments, including PPE gowning. The Manufacturing Technician I works collaboratively to support other manufacturing areas as required. The position requires superior leadership behaviors of the Alcami core competencies and non-negotiables, as well as expertise in functional competencies for the role. etc.

The Quality Specialist II is accountable for driving results in a fast-paced environment by effectively performing activities of some variety and complexity to ensure quality and compliance with applicable regulatory requirements. These activities may include reviewing documents and data, conducting basic floor audits and processes inspections, consulting on quality and compliance issues, maintaining quality databases and performing trend analysis where needed, and performing quality and compliance training as needed. The Quality Specialist II assists with the development of SOPs or other quality documents as needed. The position requires superior leadership behaviors of the Alcami core competencies and non-negotiables, as well as expertise in functional competencies included in this position profile. etc.

The Quality Specialist II is accountable for driving results in a fast-paced environment by effectively performing activities of some variety and complexity to ensure quality and compliance with applicable regulatory requirements. These activities may include reviewing documents and data, conducting basic floor audits and processes inspections, consulting on quality and compliance issues, maintaining quality databases and performing trend analysis where needed, and performing quality and compliance training as needed. The Quality Specialist II assists with the development of SOPs or other quality documents as needed. The position requires superior leadership behaviors of the Alcami core competencies and non-negotiables, as well as expertise in functional competencies included in this position profile. etc.

The Process Engineer I (Sterile) for our parenteral site in Charleston, SC is accountable for driving results in a fast-paced environment by providing technical support for the manufacturing facility, including, troubleshooting validated processes, process deviations and investigations, transfers of new processes and technologies into the site and preparation of documentation to support validation and process transfer activities.

The Process Engineer I/II is accountable for driving results in a fast-paced environment by providing technical support for the of tablets and capsules for commercial distribution and clinical use. The Process Engineer I/II in this position will provide technical assistance including but not limited to the following: transfer of new process and technologies into the company and writing appropriate documentation to support process transfer and validation activities, sourcing and qualification of equipment and components, troubleshooting current validated processes, initiate process deviations and conduct investigations.

The Metrology Calibration Technician I is accountable for driving results in a fast-paced environment by performing scheduled and unscheduled calibration, preventive maintenance (PM), and repair tasks in support of typical analytical and/or process instrumentation prevalent within the bio-pharmaceutical industry. Examples of instrumentation supported include but are not limited to: temperature and pressure measuring instruments, micrometers, calipers, torque testers, hardness testers, balances

The Associate Scientist II, Fermentation supports the execution of 1-L to 1000-L scale microbial fermentations. This role works collaboratively with team members and as an individual contributor. This position requires excellent laboratory skills, attention to detail and excellent documentation practices. Responsibilities: Assist in execution of 1 L 1000 L scale fermentations. Prepare microbiological culture media and other culture reagents. Transform E. coli with plasmid DNA. Harvest E. coli cultures using centrifuges and TFF devices. Prepare and analyze cell lysates (SDS PAGE, Western Blot, Concentration Assays). etc.

The Shipping and Receiving Specialist is responsible for supporting the storage and inventory management of materials, the shipping of materials to the clients, and staging materials for client and internal projects. Responsibilities: Responsible for receiving and storing of incoming materials. Performs physical inspection of materials at the time of arrival. Responsible for ensuring purchase orders match items received. Package material for shipment according to established procedures. Performs periodic cycle counts to verify inventory accuracy. etc.

The Upstream GMP Biomanufacturing Operator works daily within Aldevron’s manufacturing areas, performing tasks associated with Aldevron’s GMP-Source plasmid DNA production services. This role focuses specifically on bacterial cell growth, including transformation, subculture, cell banking, fermentation, shake flask growth, wave growth, and harvest. Responsibilities: Plan and submit inventory requisitions. Plan and preparation of production events and process plan memos. Coordinate production events with buffer preparation operators. Perform upstream production events. etc.

This position supports the Operations Training Group in use of technology software, hardware, applications, video, etc.… for training development and delivery. Supports the development of content for the departmental training materials for Good Manufacturing Practices (GMP) training. Provides basic information technology training classes and training resources to departmental areas of responsibility. Provides training information technology guidance to area trainers and maintains/updates the departmental Sharepoint site. This position supports a comprehensive operations training strategy that aligns to the departmental talent strategies and supports the overall organizational strategy. etc.

This function is responsible for supporting the daily on the floor activities related the manufacturing operations and quality systems. Functions include on the floor batch record review, discrepancy identification, logbook review, status tagging, room/utility checklists, document control and product shipping. This function thresholds events to Senior Associate when they are outside of the area of responsibility. The position will perform general QA work, using their ability as a skilled contributor in completing tasks where judgement is required in resolving problems and making recommendations. Works on problems of a diverse scope where analysis and problem solving is required. Receives general oversight and guidance on approaches to complete project related tasks. Applies job related skills and understanding of policies and standards in completing tasks. etc.

Support and assist in the manufacture of pharmaceutical products for commercial and clinical supplies. Scale-up and transfer formulations/processes to production facility, design and recommend equipment purchases, write and execute qualification/validation protocols. Troubleshoot automated equipment for pharmaceutical formulation and packaging. Identify and implement process/equipment improvements (utilizing Change Control system) to reduce waste and increase process reliability. Support of manufacturing management in periodic review of existing and new revisions to manufacturing documentation in regards to, but not limited to, Operability, Technical accuracy (technical reviews), Compliance, Process Robustness. Perform process and equipment evaluation (FMEA, etc.) to identify risks and weaknesses in new and current processes, etc.

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

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

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

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

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

The Quality Systems (QS) Specialist I will be responsible for effectively ensuring non-routine events are investigated and documented in accordance with company SOPs, policies and cGMPs. This is a cross-functional position that interacts with All departments at PharmaForce. The incumbent will participate in organizing the quality systems to meet or exceed the company's quality expectations. ESSENTIAL DUTIES AND RESPONSIBILITIES: Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Under the direction of the Quality Systems (QS) Manager, the QS Specialist I will: Coordinate specific departmental activities with the goal of maximizing efficiency of management control systems, programs, policies, work methods and procedures. etc.

Duties: Perform analytical chemistry analyses in accordance with company SOPs and protocols following cGMP guidelines. Log-in samples. Work with potent chemical reagents and standards. Summarize data into reports. Ability to multi-task. Performs special projects as assigned. Test and analyze samples within the specified turn-a-round time. etc.

Sets up and operates conventional, special purpose, and numerical control (NC) machines and machining centers to fabricate metallic and nonmetallic parts by performing the following duties. Studies blueprints, sketches, drawings, manuals, specifications, or sample part to determine dimensions and tolerances of finished work-piece, sequence of operations, and setup requirements.

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

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

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

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

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

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

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

The Sample Receiving Technician performs tasks such as Certificate of Analysis preparation, sample pickup and sample log-in. Technical support is performed in accordance with standard operating procedures and adheres to documentation practices in accordance with ALG-West policies. Sample Receiving personnel are responsible for reporting any adverse or unusual events to management, as well as participates in process improvement activities as needed. etc.

Analytical Lab Group is looking for laboratory technicians to perform environmental monitoring at client facilities and microbiology testing in the microbiology lab. This is a full-time position at our West Coast location. The schedule will be Monday-Friday, 7 a.m. to 3:30 p.m., but you must be able to work flexible hours, including different shifts and weekends. At this time, the starting hour is 5 a.m. and will require OT. Duties: Perform air sampling in cleanroom or laboratory areas. Collect and test microbial and chemical water samples. Collect and test compressed gas samples. Chemical cleaning and sanitization of equipment. etc.

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

Assists in material handling, equipment set-up and breakdowns, documents process according to Master Production Records, and works with trained operators at assigned work centers to learn all aspects of the position, including batch record documentation, equipment set-up, operation and clean up.

The position is primarily responsible to provide local and remote hardware and software support for desktops, laptops, printers, and other peripherals. This position interacts with all levels of employees and candidates must be able to maintain a courteous, professional manner. Provide hardware and software support for all desktop, laptop, and other mobile users, to established standards and IT Service Level Agreement

Read and understand labels and batch records. Visual and Physical Checks on Product and Machine. Ensure compliance with all approved standard operating procedures based on regulatory and internal requirements. Review batch records to examine potential for corrective action

Major Responsibilities: Provide training to new employees on cGMP concepts, SOPs, Batch Record execution, Batch record reviews, and Investigations. Basic understanding and knowledge of techniques, instrumentation, and lab functions to identify problems and support the completion of work assignments. Review proposed SOP revisions and provide feedback to management. Real-time audit of batch records in the production suites for completeness, documentation, calculation errors and conformance to critical process parameters. etc.

Primary Responsibilities: Must manage and organize the glass cleaning operation according to approved standard operating procedures. Must manage time well. Must be able to perform daily tasks in a timely manner – improving productivity while minimizing idle time. Follow approved GMP manufacturing directions such as standard operating procedures and other instructions in support of production. Responsible for documenting all production operations in logbooks and/or batch records. Perform the scheduled clean room cleaning activities as described by the standard operating procedure. etc.

Perform scheduled cleaning of all water rooms. Perform scheduled cleaning of all Lyophilizer mechanical area. Help perform daily POU Flushes and twice a week POU Sanitizations. Perform any non-GMP cleaning as assigned. Must have good time management skills. Must be able to perform daily tasks in a timely manner – improving productivity while minimizing idle time. Follow approved GMP manufacture directions such as standard operating procedures and other instructions for in support of production. Responsible for documenting all production operations and cleaning activities in logbooks and/or batch records. etc.

As an Associate Engineer, you will be responsible for working within the framework of a team and performing the following activities: Develop and update engineering documents such as manufacturing instructions, drawings and test procedures. Review and evaluate non-conforming materials, address customer experience reports, perform root cause analysis, and propose corrective/preventive actions.

As a Quality Engineer II, you will use your skills to support medical device quality through design controls, process validations and documentation as part of a cross-functional team. Conduct experiments to prove hypotheses. Create and validate test methods for design verification and manufacturing inspection testing by using measurement system analysis, gauge R&R and other relevant techniques.

Applied Molecular Transport, Inc. is looking to hire a research associate in analytical method development and quality control (AD & QC) for its therapeutic programs. Perform analytical method development for LC based assays such as SEC, IEX and reversed-phase HPLC, and other protein-based analysis (i.e. SDS-PAGE, western blot, A280). Provide testing support for the in-house manufacture of drug substance and drug product. Execute stability studies to evaluate and characterize protein degradation during storage

At Arbor, you will be at the cutting edge of biodiscovery, systematically searching through nature’s diversity to discover and engineer new technologies for improving human health and sustainability. As a Software Engineer in Research, you will focus on building a search engine from the ground up. You will have significant latitude towards ideation, problem definition, and finding novel uses of machine learning.

Evaluates and implements protocols and methods to inspect and test raw materials, in-process materials and finished products to ensure that they are in compliance with internal safety and quality standards for distribution as a Research Use Only (RUO) In-Vitro Diagnostic. Performs analysis and identifies trends in QC data and recommends corrective actions when necessary. Develops processes and tests with LEAN concepts in mind to determine that appropriate quality control analysis is being performed.

Associate level position for manufacturing medical devices in accordance with controlled procedures (SOPs) in compliance with Good Manufacturing Practice (GMP) regulations and current GMP (cGMP) guidelines. Manufactures solutions, labels and fills containers, labels and assembles kits. Compiles auditable electronic or paper records of manufacturing, maintains equipment logs and monitors supplies.

Arcus Biosciences is seeking a highly motivated and team-oriented candidate for the position of Research Associate in the Drug Metabolism and Pharmocokinetics (DMPK) Department. Develop, troubleshoot, and validate LC-MS/MS based bioanalytical methods. Analyze, summarize and report preclinical pharmacokinetic and toxicokinetic results

The Manufacturing Engineer will be responsible for leading and participating in creating, finding, and evaluating better and more efficient ways to manufacture products and provide ongoing production support for Argon Medical products and manufacturing sites. The Manufacturing Engineer will work to manage and communicate progress towards project goals to management effectively. The Manufacturing Engineer will work to gather and document customer requirements, translate them into measurable product requirements, and provide engineering support for the development and manufacture of Argon Medical Device products. etc.

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

The position requires the performance of variety of task including development and validation of analytical methods and qualitatively/quantitatively testing routine and non-routine client samples. This position requires knowledge of commonly used concepts, practices, procedures, and instrumentation (HPLC/IC) used in a chemistry laboratory.

The position requires good working knowledge of binding, thermodynamics and equilibrium, and kinetics. Contribute to screening of small-molecule and RNA interactions by SPR, MST, FP, and other assays as needed. Be motivated to independently analyze and report data from 100-1000s of small molecule candidates on a routine basis and report progress to team.

Arrowhead is seeking a highly motivated associate analytical chemist to join our growing Discovery Chemistry team. The successful candidate will be tasked with biological sample preparation and running HPLC to support ongoing discovery activities. S/He will be expected to: Follow the instructions to prepare samples from various biological matrix such as plasma, urine, tissues etc. Perform sample analysis using HPLC

Arrowhead Pharmaceuticals is seeking a highly motivated individual to become a part of its scientific team. We have an immediate opening for an Associate Production Chemist in the Chemistry, Manufacturing, and Controls Group. The successful candidate will be expected to: Follow batch records, SOPs, and work instructions to detail. Document all operations in batch records and notebooks. Comply with GMP protocols

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

The Arthrex Veterinary Sales Associate is responsible for generating sales of products and equipment to both existing veterinarians and new customers within an assigned sales territory. The Arthrex Veterinary Sales Associate plans and makes sales calls, and selects products and programs that motivate customers to buy products.

Performs manual and fixture assisted device assembly and packaging on medical device components, kits, convenience packs and / or any clean room specific device assembly as assigned. Performs placement of components onto the blister trays and die cut restraints. Performs label application onto packaging constructs. Performs supplemental label application, blister loading, pouch and blister sealing and visual seal inspection

The Biomanufacturing Associate supports the the manufacturing efforts of ArunA Bio, and must work collegially and collaboratively as part of a larger team. The position requires the individual to carry out complex stem cell manufacturing with an advanced degree of detail, and in accordance with established SOPs, cGMPs, and safety regulations. The individual will work as a member of a team responsible for performing all bioprocessing workflows.

The Research Associate I will perform cell culture, execute analytical and functional assays to characterize exosome modifications and assist with in vivo procedures. Perform mammalian cell culture using sterile technique. Use a variety of equipment such as pipettors, balances, ultracentrifuges, laminar flow hoods, incubators, microscopes, centrifuges, plate readers, and nanoparticle tracking analysis equipment such as NanoSight

In this role you will primarily be responsible for CHO cell line generation and process development. Plasmid DNA preparation. CHO cell line development for expression of monoclonal antibodies, bispecific antibodies, Fc-fusions and other therapeutic proteins. CHO cell culture process development

Provide technical support for endotoxin and glucan detection products. This includes answering questions, troubleshooting for current ACC customers. Troubleshoot/triage issues, problems and complaints in a timely manner, documenting them in CRM and providing trending to manager. Frequent follow up on all issues ensuring timely resolution of the customer’s issue. Knowledge of relevant instrumentation and softwares used for endotoxin and glucan detection by the end users

In this position you will perform routine manufacturing operations for the manufacture of ACC and SKK commercial products. You will carry out cGMP manufacturing operations based on Standard Operating Procedures. You would need to come onboard initially Monday thru Friday for a few months to train in gowning, filling, crimping, lyo, oven operation, and autoclave operation

The candidate will be a part of Dosage Form Design and Development group working on combination device characterization and functionality, development of novel technologies, and transforming scientific knowledge / analysis into practical implementations. Innovate, develop and evaluate device characterization techniques and technologies as they relate to device development requirements. Perform test method qualification and method transfer to GMP testing group in support of device verification & validation testing.

Develop and characterize purification processes for the manufacture of biopharmaceuticals (viral vectors, antibodies and other proteins) in early stage clinical development. Be responsible for a portion of a purification process development project. Make observations, analyze data and interpret results. Maintain accurate records of experimental results, review, analyze, and interpret experimental data.

Proven ability to perform all process steps of upstream / downstream / central services production operations and act as the primary trainer of those with less experience (and may act as interim Lead as required). Ability to generate SOPs, MPRs, and SPRs for equipment and procedures used in the manufacture of biological based products. Execution of validation protocols as required as well as the ability to execute projects with minimal instruction and strategic direction.

The Associate Technician performs entry-level Field Services duties to gain knowledge and understanding of cleaning and passivation of vessels and piping. Under supervision, Associate Technicians work together to complete the process in a safe and expedient manner to prevent unnecessary down time of the customer equipment. Proper calculations and installation of Astro Pak equipment plus vigilant operation of said equipment is necessary.

This position is responsible for creating purchase orders and shipping inventory for outside processing. Counts and verify parts for outside processing. Packages parts safely for shipping. Creates purchase order for outside processing. Files all work and purchase orders. Delivers products to vendors when needed.

Atomwise is looking for a Research Associate to support our scientific and business development teams by performing literature and database analyses and providing insightful reports and research plans. Search scientific literature, databases and biochemical structural data. Prepare scientific research plans. Understand the experimental design and methodologies in life science publications

Person will be responsible for the activities related to QA Documentation department related to Batch record issuance, Reconciliation of documents, Issuance of Control documents, file training record in company wide training folder of each employee. Maintain the Manufacturing and Packaging Batch Record Master Hard copy and Pdf soft copy.

The role of the AutomationEngineer is to ensure that all the Automated Storage and Retrieval System (ASRS), the associated features, and procedures of the Warehouse Control System are aligned and operational to ensure business continuity. The position works closely with key functional groups of Warehouse Operations and Projects to work on the new requirements and enhancements and take up continuous improvement projects to drive the operational efficiencies of the system. Apart from warehouse operations the position should work on the L3, L4 systems integration of DSCSA (Drug Supply Chain Security Act) Serialization requirements with the packaging team.

The Technician is responsible for providing a high level of accuracy, and contributing to a culture of safe work and superior customer service. Accurately records and communicates information to internal and external teams. Shares with team any changes in demand to maintain appropriate service levels. Builds positive relationships with both internal and external customers

The Technician is responsible for providing a high level of accuracy, and contributing to a culture of safe work and superior customer service. Accurately records and communicates information to internal and external teams. Shares with team any changes in demand to maintain appropriate service levels. Builds positive relationships with both internal and external customers

Under direction of the cleanroom lead and the area supervisor, the Cleanroom Assembly Technician will build a wide-range of Single-Use assemblies that meet or exceed customer requirements. Uses a variety of manufacturing and measuring equipment such as tube cutters, rulers, oetiker tools, and heat sealers. Follows engineering drawings, products work instructions, standard operating processes to accurately and efficiently build product and maintain associated data throughout the process.

The Technician is responsible for providing a high level of accuracy, and contributing to a culture of safe work and superior customer service. Accurately records and communicates information to internal and external teams. Shares with team any changes in demand to maintain appropriate service levels. Builds positive relationships with both internal and external customers

Assists in the manufacturing of Aveva’s transdermal products.Coats blends and adhesives to produce laminate.Prepares finished and slit laminate rolls.Documents operational parameters for manufacturing equipment.

This position will work with the Quality Control team in supporting our efforts in this exciting new area of gene therapy. This position will be responsible for environmental monitoring, product and raw material testing, and other general QC microbiology sampling and testing processes. Perform environmental and utilities monitoring in clean rooms and subsequent analyses.

The Training department is responsible for developing the skills and knowledge of site employees, allowing development within their current role, as well as enhancing careers within AveXis. The Training Associate is responsible for the day-to-day operation of the Learning Management System (LMS), monitoring and reporting compliance to the program, and assisting with the identification and development of training content.

As part of the Manufacturing organization, the Quality Control (QC) Investigations Specialist will be responsible for the investigation and completion of laboratory investigations and non-conformances aimed at identification of root cause, assessing potential impact and implementation of corrective and preventive actions. The QC Investigations Specialist will help determine the validity of data, and determination of out of specification results.

As a Biotech Manufacturing Associate / Technician, you play an integral role in ensuring the on-time delivery of quality biopharmaceutical products. You get to participate in a variety of tasks including purification of biologics, keeping up-to-date GMP documentation, writing reports, ordering materials, and scheduling equipment services.

We are seeking a Research Associate to join the Drug Metabolism & Pharmacokinetics (DMPK) team at Avidity Biosciences in La Jolla, CA. This position will require hands-on lab work with responsibility for processing and analyzing animal blood and tissues, RNA isolation, quantitative RT-PCR, ELISA, Nanostring, mammalian cell culture, western blot, chromatography (RP-HPLC, SAX, SEC, etc), and pharmacokinetic analysis.

Translates operations to streamline workflow processes within the ERP application. Configures, administers, upgrades and maintains the company's ERP. Optimization and streamline business processes within QAD and other IT areas as needed. Monitors system performance and usage to maintain security and reliability, coordinates new software releases, fixes, and upgrades with technical team and users.

Development and editing of technical documentation including: Standard Operating Procedures, User Requirements and Design Specifications, Commissioning and Qualification Protocols. Development of project plans, as appropriate. Execution of validation test procedures

Support services before they go live through the process of developing automation, developing security frameworks, and planning continuous delivery cycles. Engage in and improve the complete lifecycle of services inception and design, through deployment, operation, and refinement.Maintain services that are live by helping to measure and monitor availability, security, and overall system health.

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

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

Responsibilities: Essential Duties: Follows established procedures and guidelines to manufacture the organization's products according to production specifications and schedules, volume, cost, and wastage targets or quality standards. Operates machines and production equipment safely and in accordance with instructions. Monitors the quality of output to identify, discard or remanufacture faulty products. Maintains accurate daily production records so that manufacturing performance can be analyzed. Troubleshoots and resolves technical problems from the product line/process to minimize reject levels.-For more senior position, might act as a team leader to ensure that the work meets agreed targets by directly overseeing team members. etc.

Performs routine functions and analysis (dependent upon experience) as required by the specific laboratory requirement in compliance with B. Braun and cGMP specifications. Responsible for microbiological sample receiving/labeling/preparation/sampling/test/ counting/checking and recording of data analysis on finished products, stability test samples and any other test requisitions as directed. Supports the department in ensuring laboratory equipment performance, i.e. scheduling and execution of equipment qualification (IQ/OQ/PQ), calibration, maintenance and trouble shooting.

Prepares compounded sterile products and performs related activities under the direction of a pharmacist. Assists in the set up of the compounding room, equipment, and supplies for preparation of compounded sterile solutions, using aseptic technique. Performs general cleaning and maintenance duties as directed.

Prepares compounded sterile products and performs related activities under the direction of a pharmacist. Assists in the set up of the compounding room, equipment, and supplies for preparation of compounded sterile solutions, using aseptic technique. Performs general cleaning and maintenance duties as directed.

Performs routine functions and analysis (dependent upon experience) as required by the specific laboratory requirement in compliance with B. Braun and cGMP specifications. Responsible for microbiological sample receiving/labeling/preparation/sampling/test/ counting/checking and recording of data analysis on finished products, stability test samples and any other test requisitions as directed. Supports the department in ensuring laboratory equipment performance, i.e. scheduling and execution of equipment qualification (IQ/OQ/PQ), calibration, maintenance and trouble shooting.

Prepares compounded sterile products and performs related activities under the direction of a pharmacist. Assists in the set up of the compounding room, equipment, and supplies for preparation of compounded sterile solutions, using aseptic technique. Performs general cleaning and maintenance duties as directed.

Prepares compounded sterile products and performs related activities under the direction of a pharmacist. Assists in the set up of the compounding room, equipment, and supplies for preparation of compounded sterile solutions, using aseptic technique. Performs general cleaning and maintenance duties as directed.

The Chemist (Chem1) function is to develop the peptide manufacture process, manufacture GMP material and perform related activities at Bachem. Perform synthesis process including solution phase and solid phase peptide synthesis, peptide resin cleavage, resin cleavage with HF or other chemical cocktails. Procedures and other procedures to manufacture GMP materials, perform in-process test, package the product including other related activities

The Facilities Metrology Technician, under close supervision, performs routine calibration duties such as: tests, calibrations, repairing electrical, mechanical, electro-mechanical, and electronic measuring, recording, and indicating instruments and equipment for conformance to established standards. Thisindividual will also be responsible for all related projects and services related to the facilities equipment and their timely completion while adhering to standard practices.

Perform preparative and analytical reversed-phase high performance liquid chromatography (HPLC) and isolation operations with direction from supervisor. Follow written procedures such as Standard Operating Procedures (SOP) and Batch Production Records (BPR). Comply with SOP’s in all aspects of the work and follow GMP regulations. With appropriate training, become well-versed in operation of specific chromatography platforms used in the GMP Manufacturing Group

The Quality Assurance Specialist I fulfills a critical role for Quality Assurance. This individual will conduct real time batch record review, perform internal audits, contribute to GMP system improvements, write technical documents, and review GMP documentation and reports. This individual must also provide GMP and related training.

Receiving operation is responsible for accurately receiving product from the B&L Manufacturing Operation along with other third-party vendors, putting product into assigned storage locations, and retrieving product and delivering it to the pick area and/or shipping lanes. Also, perform shipping duties including preparing orders for shipment consisting of pallet stacking, labeling and wrapping. All order transaction controlled via RF computer. Shipping operation is responsible for accurately retrieving product from the pick area. Also, perform shipping duties including pallet stacking, labeling and wrapping. Other responsibilities include truck loading and general warehouse housekeeping. All order transaction controlled via RF computer. etc.

Conduct environmental monitoring (EM) per specifications for the Rochester Manufacturing Plant. Support the EM program through analysis and communication by adhering to established guidelines. Contributes as a team member and performs specifically defined work/projects. May participate in quality projects or teams. Responsibilities: Support environmental/water monitoring for the Rochester Plant. Specific responsibilities include scheduling, sampling, testing, and maintenance of supplies. Perform microbiological testing as part of the core competency function. Includes routine testing and validation support to the Rochester Plant and R&D. Initiation of NCR when pre-established levels are exceeded. may assist with root cause investigations/CAPAs when necessary. Preparation/review of memos, reports, SOPs, and protocols. etc.

Conduct microbiological analyses on raw materials, in-process and finished products. Collect samples related to Environmental Monitoring program at Baxter manufacturing area. Work under minimum supervision. Use laboratory instrumentation and computer systems to collect and record data.

Conduct microbiological analyses on raw materials, in-process and finished products. Collect samples related to Environmental Monitoring program at Baxter manufacturing area. Use laboratory instrumentation and computer systems to collect and record data. Perform advanced assays requiring precise analytical skills and understanding of microbiological principles.

Conduct biological, chemical and physical analyses on pharmaceutical products (biologic and drugs) and medical devices through all stages of the manufacturing process from incoming raw materials to finished goods, and environmental monitoring programs Conduct critical biological, physical analyses on raw materials, initial, in-process and final products, and samples collected from environmental monitoring programs at Baxter manufacturing facilities

Conduct biological, chemical and physical analyses on pharmaceutical products (biologic and drugs) and medical devices through all stages of the manufacturing process from incoming raw materials to finished goods, and environmental monitoring programs Conduct critical biological, physical analyses on raw materials, initial, in-process and final products, and samples collected from environmental monitoring programs at Baxter manufacturing facilities

Understand the potential hazards and safe equipment operating practices in a manufacturing environment; Understand the quality systems and guidelines that impact areas of responsibility including component specifications, equipment operating parameters, data collection and cleanliness requirements; Ensure all potential equipment deficiencies and component defects are properly identified throughout areas of responsibility to ensure adherence to quality guidelines;

Assemble and package various products; Perform rework and inspection on the product;Be aware of quality standards and ability to identify defects in products;

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

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

As part of the software development team, you’ll work with a variety of technologies to bring new products to market. We develop product software with primarily a C#/.NET windows-based technology stack. As an R&D software engineer, you could be writing code to control mechanical systems, design UIs, and interact with databases and web services.

Under minimal supervision, serve as lead to assigned customers; complete troubleshooting, installation, validation, maintenance, and service repair needs on designated equipment. May assist and/or train newer Field Engineers. Provide excellent and efficient service to Beckman Coulter’s customers, along with technical training on products

The Systems Analyst - Regulatory is responsible for providing submission publishing and technical support of the Regulatory systems for BeiGene. This position provides global support to the Regulatory Affairs and Regulatory Operations organizations with an immediate focus of supporting technical projects and regional regulatory filings. This position will collaborate closely with the submission project managers for submissions and the Information Technology team for the Regulatory technology platforms to ensure system and processes are followed in compliance with ISO, FDA, Sarbanes-Oxley and other regulatory requirements.

The Research Associate I will be responsible for biomarker discovery/validation in multiple disease areas, including neurodegenerative diseases, diabetes, obesity, and cancer, using state-of-the-art quantitative proteomics platforms.Assist in high-throughput sample preparation of patient clinical samples in a team-oriented environment

This is a hands-on role responsible for overseeing and managing the investigation and on time closure of process deviations, manufacturing batch record review process, and compiling performance metrics within the manufacturing, visual inspection and materials management functions. Manage the timely review of in process and fully executed batch records against cGMP requirements as well as assist in responding to batch record queries from internal / external sources

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

As a member of the BGIA Support team, the position will support next generation processes for genome sequencing. The successful candidate will be responsible for developing and executing standard work procedures on a wide range of molecular biology techniques related to Next Generation Sequencing.

Bio-Rad is looking for a Data Analyst I. The key business projects will include team activities, data analyses and reports development, validation, training, release in Power BI for all identified Customer-Centric Global Supply Chain metrics. Will also support Technical Lead with data automation strategy and initiatives.

Bio-rad is looking for a Production Tech to produce or supports production of instruments or reagents products in compliance with established GMP procedures and ensures products are of consistent high quality. Acts as part of a technical organizational unit. Maintains instrument documentation, operates a variety of lab and/or engineering/manufacturing test equipment, and troubleshoots and repairs instrument products. (6 positions available.)

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

This position is responsible for performing small scale cell culture to produce GMP and non-GMP recombinant proteins for growth in various types of bioreactor systems, reviewing previous batch records to optimize growth conditions for recombinant protein production, media and supplement preparation, and additional duties as assigned. This position requires a Tuesday through Saturday workweek.

The responsibilities of the Manufacturing Technician are to assist the laboratory staff with the process of building and manufacturing science products. This position will assist with a variety of tasks within a laboratory setting that may include filling containers with product, feeding a production machine, labeling product, recording data, operating equipment, formulation, and plate coating.

The main responsibility of this position it to maintain production of mouse embryonic fibroblasts. Additional responsibilities include media and supplement production, QC testing of methylcellulose-containing cell culture media, and cell culture of multiple cell lines. Perform additional duties as assigned. Preferred skills include cell culture, high attention to detail, strong communication and organizational skills.

Perform Quality Assurance (QA) audits, inspections (internal/external) and monitoring procedures against standard operating procedures, methods, protocols/plans, guidances, and/or regulations, as applicable. Assist in hosting regulatory inspections by acting as scribe and/or reviewing documents and identifying and calling operational staff to answer questions as required

Prepare worksheets with minimal supervision. Prepare plate maps. Serve as lead analyst on sample analysis projects. Troubleshoot assays. Compile/process data (make power export)

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

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

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

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

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

The primary role of the Patient Service Coordinator is to facilitate the customer lifecycle by assisting patients, healthcare providers and others with activities related to starting and staying on therapy. Patient base includes both newly diagnosed and existing Alzheimer patients. Daily interactions involve contact via phone not only with patients but also health care providers, Biogen field force representatives, business service partners, nursing services and other internal work groups.

In this role you will be responsible for performing and documenting daily manufacturing operations in a cGMP environment. This involves operation of process equipment, execution of validation protocols, creating/ revising cGMP documents and other assignments. Applicants will be highly detailed oriented with excellent documentation skills. Applicants will become trained and skilled at most or all unit operations in their area, often leading the execution of procedures, and performs most functions with minimal supervision.

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

Primary responsibility is support for the Assay Services subgroup within Analytical Sciences. This position involves performance of a variety of analytical assays with adherence to strict timelines. Assays may include enzyme activity, total protein, cell-based bioassays, chromatography and electrophoresis, done under the supervision of more senior personnel. Assists in the qualification of assay methods and in their transfer to the Quality Control laboratories. Provides major contributions to the evaluation of drug substance and drug product. Receives and records results for Assay Services in support of a variety of different groups including QC, MFG, Cell Culture PD, Purification PD and Formulation.

The Analytical Sciences Department is seeking a Research Assistant that will be responsible for coordinating with lab support service providers and multiple departments such as Facilities, EHS&S, Lab Support, IT, Vendors and Contractors to ensure that Analytical Sciences Department needs are met. Performs good documentation practices with instrument and equipment laboratory logbooks and ensures compliance in their documentation.

Operate plastic injection molding machines. As the Injection Molding Machine Operator you will set up and operate an injection molding machine in order to shape plastics. You will read and interpret blueprints and diagrams to select, position, and secure machinery. This is a hands-on role.

This technician works within a project team under the leadership of project management and other senior engineers. The technician is expected to perform various types of technical activities including testing, verification, operation and manufacturing of prototype medical device consumables. This technician is expected to work and communicate well with other members and leadership of the team in order to meet the goals of the project.

The software test engineer works aside the software team to assist in producing quality software. This position is responsible for the design, implementation and execution of tests to verify that software and firmware operate correctly and meet design specifications. This individual should work creatively to automate testing where feasible. This individual should have knowledge of one or more programming languages.

Conduct telephone eligibility screening of potential English-speaking volunteers for inclusion or exclusion in all phases of clinical trials which includes but is not limited to, Reviewing screening criteria, Providing an overview of the study,Responding to volunteer preliminary questions, Capturing brief medical and medication history of volunteers, Completion of required paperwork.

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

The Phlebotomist provides expertise in blood draws and specimen preparation. Their ability to put patients at ease and obtain sufficient samples with minimal discomfort to patients across a wide demographic is critical to our commitment to high quality care for our patients and those of our partners. Experience doing blood draws, labeling specimens, centrifuging specimens, recording maintenance data and decontamination, updating patient information, etc.

The Specimen Processor must maintain departmental production goals to ensure hourly specimen flow to the labs are consistent. In this role, you will prepare samples for shipping, ensuring they are secure and shipped to the correct laboratory. It will also be your responsibility to handle patient medical records with complete accuracy and confidentiality.

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

The responsibilities of this position are to perform ELISA assays to check for quality performance of product, maintain accurate documentation of results, and maintain assay databases. This position will focus on quality control testing of serological assays. This position may also contribute to quality control testing of Quantikine ELISAs, Luminex assays, and/or IVD kits. Perform raw material qualification testing as needed. Calculate data and compile results efficiently. Collaborate with others and perform general lab duties as needed.

The responsibilities of this position is to purify proteins for restock and modify existing protocols to meet the demand of our customers. This position will require assistance with basic lab operations and routine guidance on how to follow SOP’s and purification methods.

You will be responsible for assisting in the Clinical Controls Product Finishing Department with the bottling operation and the other activities involved in the product finishing process. Cap vials or tubes, operate the torqueing equipment. Assist department in maintaining inventory of vials, tubes, closures, Styrofoam trays and dividers.

Bio-Techne’s Protein Platform Division is looking for a Manufacturing Technician with a motivation to participate in the growth of a fast-paced company engaged in cutting edge biological research. The successful candidate will work with other members of the Reagent production team to make great products, performing tasks involving plate filling, labeling, vialing, and finishing materials. Operation of semi-automated liquid dispensing equipment is integral to the job. etc.

As a part of our San Jose team, the successful applicant will work with other members of Consumables Production, as well as a multidisciplinary team of engineers and scientists, to support the assembly of microfluidic cartridges for biotech products. Key Responsibilities: Operate and maintain robotic and manufacturing equipment. Ability to use hand tools such as small wrenches, pliers, tweezers, etc. Perform in-process QC and record results. Document production batch records/travelers and computer data entry. etc.

The responsibilities of the Production Assistant are to assist the laboratory staff with the process of building and manufacturing science products. This position will assist with a variety of tasks within a laboratory setting that may include filling containers with product, feeding a production machine, labeling product, recording data, operating equipment, formulation, and plate coating. This position offers 1st shift hours of 5:00am-1:30pm. Key Responsibilities: Operate a production machine to fill containers with product. Feed plates into the machines. Batch and label product. etc.

The responsibilities of this position are to support the DD OEM Accounts / Shipping Manager and Shipping Department’s activities by performing order processing, proofing, set assembly, shipping and other related duties. Order processing in our ERP System. Assist in preparing final shipping documents for OEM, International, Survey and Domestic shipments. Assist with maintaining Distributor, OEM and Survey customer orders and shipping records

The main responsibility of this position it to maintain production of mouse embryonic fibroblasts. Additional responsibilities include media and supplement production, QC testing of methylcellulose-containing cell culture media, and cell culture of multiple cell lines. Perform additional duties as assigned. Preferred skills include cell culture, high attention to detail, strong communication and organizational skills.

The responsibilities of this position are to support the DD OEM Accounts / Shipping Manager and Shipping Department’s activities by performing order processing, proofing, set assembly, shipping and other related duties. Order processing in our ERP System. Assist in preparing final shipping documents for OEM, International, Survey and Domestic shipments. Assist with maintaining Distributor, OEM and Survey customer orders and shipping records

The main responsibility of this position it to maintain production of mouse embryonic fibroblasts. Additional responsibilities include media and supplement production, QC testing of methylcellulose-containing cell culture media, and cell culture of multiple cell lines. Perform additional duties as assigned. Preferred skills include cell culture, high attention to detail, strong communication and organizational skills.

The Test Engineer I will provide technical testing expertise as part of an Agile development team and be a trusted team member for BioTel Research’s clinical research services. The Test Engineer will refine the product backlog, ensuring the quality and reliability of all functional components used. They will ensure that all systems meet customer requirements in a manner that is consistent with applicable regulatory requirements especially with regard to validation processes outlined in Good Clinical Practice and Good Manufacturing Practice and maintaining Separation of Duties.

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

In this role you will gain market share in the cardiac rhythm business by promoting, selling, and servicing Biotronik’s products within an assigned territory. Sales Representatives perform field promotional work to sell and develop new business; this may include work with current accounts, or with customers where product acceptance has not been established. Biotronik seeks candidates who will meet and exceed our customer expectations by striving for the greatest possible reliability and quality in our products, processes and systems by being accountable and taking action.

Meet or exceed sales objectives set by the BioVision management. Learn and master BioVision's product offering and manufacturing capabilities . Establish long-term relationships with the customers and match BioVision's capabilities with customer needs. Identify key contacts and decision makers to maximize the benefits from customer visits

BMG LABTECH, a market leader in microplate instrumentation, is looking for a motivated individual to join our technical service and support team to be based in the greater Boston, MA area. Provide technical support for BMG LABTECH instrumentation. Inside and outside sales of product service plans, accessories, and upgrades via phone, email, and onsite visits

The QC Microbiologist I conducts quantitative and qualitative analysis of pharmaceutical products according to FDA, cGMP and Boston Analytical, Inc. Standard Operating Procedures. Duties will include analysis of pharmaceutical products through compendial methods and client specific test protocols. Prepares and analyzes samples to determine microbiological quality through the following analyses: Microbial enumeration methods, absence of specified microorganisms, endotoxin, and water quality analysis (bioburden, TOC, Conductivity).

The Specimen Processor enters all patient demographic and testing information into the laboratory information system and prepares blood samples for the analytical phase. Accurately and efficiently complete data entry of patient info and order codes into the system. Verify that samples received are: labeled with the correct patient identifiers, the correct sample type, and within stability for the requested test(s)

This role will assist in developing and refining failure analysis methodologies as a means of advancing comprehensive understanding of product performance to improve patient outcomes. This position will identify, analyze, investigate, monitor and document patterns and trends in complaint data. Communicate and educate management, R&D, Design Assurance, Ops Quality, Marketing, Sales and other departments about product performance and escalations. Ensure that information and insights gained from product investigations and corrective actions is fed back to the R&D, Design Assurance and Marketing organizations as part of the risk management and design input process.

The Associate Process Engineer provides technical leadership related to new and existing sterile drug products. This position is supports the technical interface with R&D to ensure design and transfer of robust manufacturing processes for new products and key life cycle management products, development of new technology for optimization and continuous improvement in manufacturing operations, providing specialized expertise as necessary to complement site capabilities for critical investigations or process improvements, setting relevant standards and creating and maintaining associated Directives (e.g, for tech transfer, Product monitoring, etc).

With minimal supervision, design and execute experiments to assess impact of cellular metabolism and cytokine signaling on T cell phenotype Optimize cell culture conditions as well as media components that can help improve process performance and achieve desired product attributes Critically analyze and interpret data using statistical methods Summarize experimental results and present them for internal discussions.

The Process Engineer will be responsible for implementation of projects for the manufacture of APIs and bulk intermediates and other products from development through piloting and/or commercial production. Writing batch records, cleaning records, SOPs, campaign reports, supplements, and investigation/deviation reports as needed to support production operations.

A Cleanroom Services Technician will support the Cleanroom Services team by assisting filed analysts with a wide range of tasks including: equipment setup and stocking supplies, vehicle and equipment maintenance, facility administrative housekeeping. Additionally, this role will be responsible performing work at client sites as needed.

Independently manage and maintain multiple cell lines in support of process development activities. Design and execute studies to develop and optimize a scalable manufacturing process and analytical assays for production, isolation and characterization of exosomes. Prepare technical summaries to disseminate study results including making detailed observationsand data collection and analysis

Warehouse Operations 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. Also responsible for the efficient flow of products from the point of product receipt from vendors to the shipment of products (via prescribed service parameters) to a variety of internal and external customers.

Inventory Management is accountable for the design and execution of demand planning and customer forecasting systems, supply planning, product deployment and expediting processes, and the development and implementation of a stocking optimization model to minimize costs and inventory while delivering on service requirements.

Sets up and operates a variety of machine tools to make metal parts, mechanisms, tools, or machines to exacting tolerances and dimensions. determines sequence of operations, number of cuts required, and method of setup. Interprets blueprints, sketches, and engineering specifications. makes standard shop computations relating to dimensions of work, tooling, feeds, and speeds

The Clinical Laboratory Assistant (CLA) performs a variety of laboratory and administrative tasks to support the clinical laboratory staff in the CLIA-certified CareDx laboratory. A CLA performs laboratory duties under direct and constant supervision of a licensed CLS or the Clinical Laboratory Manager (CLM) and/or designee, who provides specific instruction regarding how tasks are to be completed and defines the steps to be employed.

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

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

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

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

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

The Manufacturing Associate II is responsible for supporting the overall GMP manufacturing process, through the application of broad knowledge of theories and principles utilized to solve operational, as well as routine tasks in the production of bulk biologics from microbial and cell culture systems for Phase I/II & commercial GMP manufacturing. The Role: Completes Batch Production Records under cGMP, and documents in detail through the use of SOPs and BPRs for the processes and manufacturing steps. Support initiation and closure of deviations; may serve as the lead in the departmental investigation and be responsible for closing out deviations and CAPAs. etc.

The Manufacturing Associate I perform 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 is critical to our patients. Manufacturing life-saving medicines right the first time with patient safety in mind is our priority. Quality, safety and on-time delivery is a must to be successful in this role! etc.

A manufacturing associate’s primary duty is to perform variety of operational tasks in accordance with current GMP’s. Responsibilities include: Follow accurately all GMP documents (Batch records, SOP’s. Protocols, etc.), safely operate production equipment, operate in a clean room environment within required gowning, aseptic behaviors, and proper flow procedures, must work effectively in a team environment to achieve company goals, must adhere to company compliance, safety and attendance required. etc.

The position is responsible for packaging and inspecting pharmaceutical products in accordance with packaging instructions, Standard Operating Procedures (SOP), and current Good Manufacturing Practices (cGMP) while adhering to health and safety requirements. The Production Associate II role is critical to our patients. They oversee all inspection of our products with safety in mind, executing with efficiency always. The Role: Monitor and direct employee position rotations on the line. Assist team lead in the coordination of OJT. etc.

The Research Associate will join our viral vector process development group supporting process development, production and characterization of viral vectors, which are key intermediates in the CAR-T drug product. The candidate will support current programs and advance our capabilities in vector production.

Design, set up, perform and analyze experiments independently. Maintain cell cultures and perform cell-based and immunological assays (e.g. ELISA, Cytotoxicity, proliferation, apoptosis). Evaluate novel cellular therapies using cellular and molecular biology techniques. Perform and analyze multicolor flow cytometry experiments.

As an Associate Consultant, you will work as a member of project teams performing commercial assessments of development-stage pharmaceutical products and technologies including forecasting, market and pipeline analyses, identification and evaluation of licensing and partnering opportunities, and development of clinical and commercial positioning strategies.

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

The Quality Control Analyst II will perform qualification and manufacturing of template materials used in internal product testing and as raw materials for production according to established procedures. This position will be working in Quality Control to support control reference material production as well as stability program activities in accordance to GMP standards and FDA/ISO regulations.

Assist Supervisors/Training Specialists in coordinating, delivering, and monitoring training activities that directly affect manufacturing processes, including QSR/GMP compliance. Facilitate and deliver classroom training sessions. Serve as the point of contact for specific learning programs, as assigned.

Perform analytical studies to verify GeneXpert assay performance based on the ability to meet design input requirements. Analyze data using statistical tools such as Microsoft Excel or MiniTab. Handle clinical samples and perform microbiology work of BSL-1 and BSL-2 organisms. Demonstrated ability to apply analytical problem-solving skills to reagent and system integration issues to identify critical performance factors.

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

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

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

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

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

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

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

Assist in designing and creating expression vectors for use in bacterial and insect cell heterologous expression systems using robotic liquid handling systems. Perform small-scale and pilot-scale expression trials to identify conditions for soluble expression of human proteins in heterologous systems using robotic liquid handling systems. Scale-up to liter volumes of bacteria in high-density bio-fermentation systems, and of insect cells in shaking incubators

The Research Assistant (RA) is responsible for assisting with document management, protocol related clinical assessments of research subjects, laboratory functions and assisting in tasks related to the work of the Clinical Research Coordinators. Assisting in subject visits, including direct contact with subjects, processing of visit data, ensuring the completeness and integrity of source documents and case report forms (CRFs), and other related duties.

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

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. Perform protein recovery experiments using unit operations such as homogenization, centrifugation, depth filtration, microfiltration, and ultrafiltration.

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

Analyze and model pricing scenarios for Integrated Delivery Network customers (IDNs), dealers and distributors for Requests for Proposal (RFPs). Devise customer incentives with the sales team that are in line with business objectives. Calculate monthly, quarterly, and annual payments for customers including national Group Purchasing Organizations (GPO), Health Systems (IDN), and Key Accounts as indicated by contractual commitments

The Clinical Lab Assistant will be responsible for assisting in routine sample processing in a high complexity CLIA-certified laboratory, and you will be working with other laboratory professionals who have joined Color from UCSF, Stanford, Invitae, Counsyl, and other academic and commercial laboratories. Assist in routine laboratory maintenance, including equipment maintenance, maintaining lab cleanliness and a safe laboratory environment

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

Coordinate and conduct customer training for MGI NGS products and applications. Troubleshoot issues related to experimental design, data processing, software operation, sample preparation and chemical reaction. Perform preliminary on-site failure analysis to identify root cause and feedback to corresponding company department or personnel.

Concerto HealthAI is looking for a Quality Control (QC) Reviewer who will be responsible for reviewing and ascertaining the quality of curated data across the Data Curation Services (DCS) Division. The QC Reviewer works under the direct management of the Quality Control (QC) Manager. This role can be remote or based out of our Memphis office.

Develop and maintain strong internal working relationships across Conformis. Understand the objectives, responsibilities, and mission of the Quality department and work towards those goals. Prioritize and plan work activities; adapt for changing conditions. Develops and initiates standard methods for inspection, testing, and evaluation, utilizing knowledge in related engineering fields.

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

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

We are seeking to hire an laboratory technician for full time employment in a large-scale culture media manufacturing facility. Candidate will be involved in a wide range of process tasks from maintaining an ISO certified cleanroom to final product.

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

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

Currently, we seek an Operator I to work the weekend day shift at our Grand Rapids facility. The Operator I will set up and operate extrusion equipment to produce products to meet cGMP, customer and internal quality standards for our Grand Rapids facility. As an Operator I, you will: Set-up and operate extrusion equipment. Perform basic maintenance and troubleshooting of equipment. Ensure production crew is on task and focused on safety, quality, and productivity

Perform work within the manufacturing department to clean equipment/rooms, dispense, and operate equipment for product studies, development, and commercial production.

Conduct marketing and sales independently in large and small biotech accounts. Create and execute sales strategy with the support of your manager. Achieve defined metrics for sales activity and revenue growth. Support tradeshow marketing and booth staffing.

Performs a variety of Sample Management and/or Archives responsibilities in compliance with appropriate SOP’s and Good Laboratory Practice (GLP), Good Clinical Practice (GCP) or Good Manufacturing Practice (GMP) regulations (as appropriate) in support of various Business Unit Operations. Ensures that services to both internal and external customers are provided in a timely manner or as agreed in Service Level Agreements.

Process daily samples according to written procedures prior to end of day utilizing histology techniques of cryotomy, microtomy, tissue grossing, tissue embedding, routine staining, special staining, immunohistochemistry (IHC) and fluorescence in-situ hybridization (FISH). Maintain accurate documentation and paper work to provide a sample audit trail. Communicate sample enquiries and issues via email to internal and external clients and work well as a part of a team as well as independently

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

The work will support projects at various stages drug discovery and development thereby allowing the selected candidate to play an active role in our drug discovery and development efforts to advance small molecule therapeutics for rare endocrine disorders and endocrine-related cancers. Perform DMPK assays for small molecules such as in vitro metabolic stability, CYP inhibition, reaction phenotyping, and metabolite profiling/identification

The individual will develop quantitative assays measuring gene editing in target and non-target cells, cell-based assays measuring the expression and the biological functions of specific genes. The successful candidate will independently design, perform, and analyze experiments for multiple preclinical and clinical programs, and will work independently to support process development, product characterization, and technical transfer to CMOs and GMP test labs.

We are seeking a talented Bioinformatics Engineer with strong programming skills to tackle challenging bioinformatics and computational biology problems. The successful candidate work collaboratively with research groups to build and maintain the tools, algorithms, and pipelines required to support the development of new, transformative CRISPR/Cas9-based gene editing therapies.

Perform microbiological testing for human tissue and medical device samples, as well as perform environmental and water monitoring. Monitor cultures for the presence of microbial growth. Hours: Mon, Tues, Wed, Fri from 7am-5:30pm

To coordinate the activities necessary to ensure that all donor records flow through the system with minimal delay. Provide a leadership role for entry level DQA individuals. Ensure that all areas outlined under “Principal Responsibilities” are accomplished in an efficient, professional manner. Read, critique, review and complete DQA form reviews per QA0175, QA0176 and QA0079 as delegated by DQA Management.

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

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

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

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

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

This position is responsible for Spirulina production system data and adjustments as necessary to stay within set operating specifications. This position will be responsible for the data necessary to track Spirulina system performance as well as data necessary for operational set point adjustments necessary to stay within system specifications, such as nutrient analyses, pond data, and harvest/processing data.

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

The Project Assistant will primarily interface with Cytel project staff but may be required to communicate regularly or ad hoc with Sponsors ( e.g. in order to report status for timelines, scope and budget) or with DMC members (e.g. to schedule DMC meetings, deliver DMC reports, etc).Manage core project documents for timelines, scope, budget, and team lists. Track timelines and budget performance, and report status to Project Management

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

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

The Sample Processor’s primary responsibility is to provide front-line support in the procurement of record of loan (ROL) material and manage chain-of-custody of samples received. This individual must support the Decipher internal and external customers in the routine functions to ensure client satisfaction and appropriate records and materials management are consistently maintained.

Types of activities include plasmid construction and preparation, transformation and culturing, plus preparing experimental media and buffers. Responsible for design, assembly, manipulation and cloning of DNA constructs for in vivo bacterial expression. Construct gene and pathway plasmid constructs using assembly methods such as: yeast homologous recombination, Gibson assembly, Golden Gate assembly.

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

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

In this role, the Technician will work alongside Engineers in order to assist in the development of products, processes, and root cause investigational efforts. The primary role being testing. The Technician will conduct measurements or tests following defined procedures. The test results will be used to determine product functional attributes, test fixture or test method design attributes, and assembly process variation.

The customer service & technical support candidate will have strong technical knowledge in molecular biology and cancer diagnostics and will demonstrate technical credibility to effectively consult with customers and internal stake holders. Day to day responsibilities will include, sales order processing, order entry/dispatching/invoicing/post sales inquiries/responding to technical inquiries and trouble shooting. In addition, you will be responsible for dealing with general customer inquiries from new and existing customers, handling incoming leads from our website and update/maintain the lead tracking database.

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. Demostrates the knowledge and skills necessary to provide care appropriate to the age of the patients served.

The Cardiac Stress Technician will work under the direct supervision of site physician, performing various professional and administrative duties related to nuclear medicine stress testing. This includes but not limited to patient preparation, administration of exercise and pharmacological stress tests, and application of ACLS measures to patients when directed.

The individual in this position must keep abreast of oncologic and immunologic diseases. Are you someone with a strong life sciences background who is analytical, decisive, detail-oriented, and an excellent communicator who's looking for a future with a growing biotech company? To be successful in this role, you must have a Bachelor's degree, preferably in life sciences. You must be able to multitask, maintain organized records, efficiently manage several projects simultaneously, think outside of the box and develop creative solutions to problems.

We're looking for two (2) standout Project Support Associates who will manage our off-the-shelf inventory projects and provide excellent support to a team of Project Managers, allowing them to remain focused on fulfilling customer expectations. To be successful in this role, you must be highly organized, detail-oriented, be familiar with medical and pathology terminology, have great computer skills, be an excellent communicator and team player.

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

Estimate, plan, and coordinate testing activities. Develop test plan, test cases, test scenarios based on Users Stories and product’s design description to meet business requirements and technical specifications. Perform ad hoc, functional, integration, and regression testing

The candidate will contribute as part of a dynamic team to the development of gene-editing based ex vivo cell therapies in multiple disease areas, including hematology and immune-oncology. In this role, the candidate will be responsible for culturing and editing cells for use in Phase I clinical trials and for the creation of cell banks in a GMP environment.

Work closely with senior scientific staff to execute reactions that involve multiple complex materials. Optimize chemistry protocols and develop standard operation procedures. Assist troubleshooting problems in experiments in terms of assay design, protocol, reagents and characterization of materials. Prepare reagents, buffers and calibration standards

As a Laboratory Operator I, you will run essential maintenance protocols for the instruments and the laboratory. These protocols are critical to sustaining the high quality operation of the facilities and provide experience working in ECL’s unique, systematic lab environment with our integrated software tools.

Responsible for preparing tubing, equipment, supplies, and other items associated with sterile filling processes. Work under general supervision of more experienced Technicians or Production Supervisor. Comply with cGMP regulations, adhere to EBSI policies, and adhere to EBSI SOP and Batch Record directions. Complete all necessary documentation in a manner that complies with Good Documentation Practices as tasks are performed

This position is responsible for the inspection and packaging of product. Will perform all aspects of Inspection and Packaging with the ability to assist in day to day operations. This position is located in Baltimore, MD at our Bayview site. Adhere to the procedures and safe practices for movement of product and materials and accurately complete all applicable documentation. This applies to room temperature and cold storage loctions.

Responsible for preparing tubing, equipment, supplies, and other items associated with sterile filling processes. Work under general supervision of more experienced Technicians or Production Supervisor. Comply with cGMP regulations, adhere to EBSI policies, and adhere to EBSI SOP and Batch Record directions

The Associate Metrology Specialist applies knowledge of measurement science, mathematics, physics and electronics to calibrate instrumentation associated with plant and process equipment, ensuring accuracy of pressure, temperature, time, dimensional and other measurements. The metrologist will adapt equipment, standards and procedures to accomplish unique measurements. They will use electronic and hard copy systems to maintain detailed records of calibrations and conduct metrology-related administration. etc.

Support the manufacturing of pharmaceutical products according to the production schedule. DUTIES & RESPONSIBILITIES: Clean and sanitize equipment as required. Clean the manufacturing and filling areas when required. Perform water sampling and EM sampling. Maintain the inventory of consumables in the cleanrooms. Follow all written procedures according to GMP standards. etc.

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

Responsible for the manufacture of biopharmaceuticals, including bench top, scale up and pilot formulations; preparing and operating process equipment, handling materials, dispensing chemicals and interfacing with Maintenance, QA, QC and Tech Group in a cGMP environment. Responsibilities: Work under general supervision of Production Supervisor to manufacture parenteral drugs. Perform compounding of pharmaceutical products following Production Batch Record. Performs and documents developmental formulation batches as required. etc.

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

This position is responsible for the timely and efficient scheduling and packaging of standard and custom products, and for providing support to other areas of manufacturing to ensure timely product delivery. Assist in all packaging and labeling operations for Manufacturing. Assist in cGMP material inspection and receiving raw materials for Manufacturing.

Identify, research and recommend new products and services for on-going projects based on client recommendations/requests and competitive intelligence. Coordinate with the project management and business development teams to identify, recommend and schedule in-person client visits when appropriate. Communicate with clients regarding services, the customer experience, potential problems, etc.

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

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

The Clinical Laboratory Scientist (CLS) performs laboratory testing, preventive maintenance, troubleshooting, calibration of equipment, quality control procedures and is responsible for the validity of test results. Perform laboratory assays in accordance with Viracor-IBT’s standard operating procedures. Operate, calibrate and maintain all laboratory equipment and instruments according to standard operating procedures to ensure quality results

Employee Responsibilities: Perform biochemical testing on proteins and antibodies including, but not limited to, CE, IC, HPLC, SEC, SDS-PAGE, UV, Protein A titer, ELISA, and Particulates. Working as part of a team in a rotating night shift role (shift pattern of 3-2-2-3) which includes working weekends and holidays when they fall within shift pattern. Enter data into LIMS. Ability to work independently and as part of a team in a GMP environment. Participate in conducting investigations. etc.

Job Description: Perform a wide range of analyses (routine and non-routine)to support biopharmaceutical testing. Analyses are primarily, but not limited to, cell-based assays and ELISA's (kit-based and de novo). Meet TAT for assigned testing/projects and work independently. Review and evaluate raw data for acceptability. Assist other technical staff in evaluation of raw data for acceptability. Contribute to the development and validation of methods used within the department.. Be able to plan and organize work week and communicate schedule to management when required. Attend client facing meetings as needed. etc.

Assay Scientist responsibilities include, but are not limited to, the following: The development and performing of assays to support biopharmaceutical testing. Prepare and pipet small volume solutions. Maintain records and test results following good manufacturing practices (GMP). Document work clearly and perform tests accurately. Perform tasks in a repeatable and efficient manner. Communicate effectively with team members and client staff. etc.

The ESH Associate will serve as the site ESH Coordinator for the Richmond Business and Innovation Center. They will implement, monitor, and support environmental, safety, health and security programs and initiatives. They will ensure that the Business and Innovation Center is in compliance with the Responsible Care and ISO 14001 standards. They will work with facilities in the region to gain an understanding of plant chemistries and operations. They will assist with regional and segment projects as needed.

The ESH Associate will serve as the site ESH Coordinator for the Richmond Business and Innovation Center. They will implement, monitor, and support environmental, safety, health and security programs and initiatives. They will ensure that the Business and Innovation Center is in compliance with the Responsible Care and ISO 14001 standards. They will work with facilities in the region to gain an understanding of plant chemistries and operations. They will assist with regional and segment projects as needed.

The Patient Access Associate I (PAAI) position is responsible for the accurate and timely filing of insurance claims for Exact Sciences. A PAAI demonstrates medical insurance knowledge by determining initial and/or ongoing eligibility and authorization of insurance including commercial, government, and plan coverage. PAAI communicates insurance information to ancillary departments and ensuring appropriate coverage by utilizing Epic, external portals, and other software.

Utilize Supply Chain tools and systems to regularly monitor demand and supply exceptions and imbalances; takes necessary steps to prevent and/or correct anticipated supply/demand problems considering all alternatives and consequences of decisions. Schedule weekly discussions with Purchasing to review planned purchases/receipts, trade priorities with suppliers to meet customer needs and identify any purchasing gaps that would need to be resolved to ensure best possible purchased supply.

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

The candidate will be responsible for creating daily compound stock solutions to support creation of library screening plates. This job will require the candidate to have excellent organization, communication, and teamwork skills, as well as flexibility and versatility, to meet tight deadlines in a dynamic, fast-moving environment.

Inside sales to white space and vacant territory business planning/support. Develop and maintain strong working relationships with target HCPs (via telephone, video conference and in person). Deliver approved, education-focused messages, as well as the assigned therapeutic area disease-state information to target HCPs (via telephone, video conference and in person).

The candidate will assist seniormembers of the MSAT teamin thedevelopment ofscaled-upculture, differentiation, purification and characterization methods foriPSC-derived cellulartherapy products. Furthermore,they will activelysupport laboratory operations by coordinating the inventory,purchaseandaliquoting of key reagents.

The Product Development Engineer will contribute to all phases of product design, development and support. Technical competencies in the areas of biomedical engineering, electrical engineering and mechanical engineering are required. Maintain familiarity with relevant portions of the FHC Quality System and perform all duties within its guidelines, specifically those pertaining to design control, software development, EC’s and CAPA

The Production Technician assists FHC Greenville. This position involves some production duties, a variety of ERP System activities, and other general business office activities. Assemble product following work and print instructions as specified on manufacturing job orders generated from FHC’s ERP system. Relieve inventory physically and/or electronically through FHC’s ERP system if needed and follow the procedures to account for all items.

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

Fluidigm is looking for a Research Associate to join our Group. The successful candidate will characterize antibodies for use on Fluidigm’s new Imaging Mass Cytometry platform. Description: Perform antibody-metal tag conjugations for a multitude of antibody/tag combination for use in multiplex assays. Perform verification studies on new metal-conjugated antibody products for use with our Mass Cytometry and Imaging Mass Cytometry (IMC) technology. etc.