- Insmed Incorporated (San Diego, CA)
- …development and process development teams to develop, qualify/validate AAV gene therapy cell -based biological potency assays, protein chemistry assays, and ... CMC team.Perform quality management activities such as deviation, CAPA, change control , investigation of OOS, OOT and anomalous results within the company QMS… more
- Aequor (Seattle, WA)
- …supports the cGMP Document Control operations for the Client Cell Therapy Above-site organization, including the document approvals, document change ... Primary responsibilities include: Managing an electronic document system for the Cell Therapy Above-Site which includes reviewing and approving document… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …for leading and facilitating Risk Assessment Projects to the cGMP Clinical and Commercial Cell Therapy Manufacturing Plant. In addition, the candidate must have ... Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms,...Quality Risk Assessment experience in the pharmaceutical industry.Primary responsibilities… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the use of quality systems such as SAP. Experience working with cell therapy is preferred Knowledge of cGMP regulations and FDA/EU guidance related to ... that include Manufacturing Operations, Quality Assurance, Engineering and Validation, Quality Control and Warehouse Operations. Requirements A minimum of a… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …multiple myeloma. Legend Biotech is seeking QC Investigations Supervisor as part of the Quality Control team based in Raritan, NJ. Role Overview The QC ... the QC testing laboratories related to the manufacturing of cell therapy products for clinical trials and...biological and/or pharmaceutical industry is required. Experience in a Quality Control setting is preferred. Experience with… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …drug product and intermediates testing from the manufacturing facility utilized for cell therapy products for clinical trials and commercial operations in ... Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms,...Lead QC Microbiology Data Reviewer as part of the Quality team based in Raritan, New Jersey. Role Overview… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of maintenance specialists and partner with cross functional areas in support cell therapy production for clinical and commercial patients. Key Responsibilities ... Maintenance and facilities management. Computerized maintenance management systems (CMMS). Quality Management knowledge, including Change control , Deviation, and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …multiple myeloma. Legend Biotech is seeking a Supervisor, QC Micro as part of the Quality Control team based in Raritan, NJ. Role Overview The QC Microbiology ... routine Environmental Monitoring sampling of the manufacturing facility utilized for cell therapy products for clinical trials and commercial operations… more
- BioAgilytix (Durham, NC)
- …then you'll be right at home here at BioAgilytix.Essential ResponsibilitiesPerform Quality Control (QC) technical, scientific, and compliance review of ... be a critical part of our beginning-to-end client data quality processes. Through your technical reviews of raw and...on regulatory requirements with your knowledge of plate-based assays, cell work, gene therapy and more.We are… more
- Aequor (Seattle, WA)
- …for the Learning Management System (LMS). The position will report to the Global Cell Therapy Quality Training Lead REQUIRED COMPETENCIES: Knowledge, Skills, ... and Abilities: Must have basic GMP and Quality knowledge. Intermediate skills to navigate a document management system (DMS) and Learning Management System (LMS).… more
- Axelon Services Corporation (Seattle, WA)
- …supports the cGMP Document Control operations for the Client Cell Therapy Above-site organization, including the document approvals, document change ... : $34-$38/hr Job Description: - 2+ years of Document Control & Reporting Experience, - Veeva experience preferred -...great communication - Experience working cross-functionally Position Summary: The Quality Assurance Document Control ( QADC )… more
- On-Board Companies (Summit, NJ)
- …This individual is expected to efficiently manage materials buying activities for cell therapy network including, purchase order placement, maintenance of ... levels of materials, and collaboration with internal and external partners. Leveraging the cell therapy network, this position will make use of existing… more
- Axelon Services Corporation (Summit, NJ)
- …This individual is expected to efficiently manage materials buying activities for cell therapy network including, purchase order placement, maintenance of ... levels of materials, and collaboration with internal and external partners. Leveraging the cell therapy network, this position will make use of existing… more
- Piper Companies (Holly Springs, NC)
- …HolidaysKeywords: automation, controls, engineer, DeltaV, pharmaceutical, industrial, manufacturing, cell therapy , rockwell, syncade, automation design, coding, ... expert knowledge and technical support to internal and external teams.Deliver high quality communication regarding projects and serve as the subject matter expert… more
- Axelon Services Corporation (Seattle, WA)
- …- Act as an effective change agent - Partner with other members the Cell Therapy Operations Training Team and other training teams across the organization ... and for business expectations regarding training design - Maintain and control electronic document content and folders as per good documentation requirements… more
- Bristol Myers Squibb (Bothell, WA)
- …here at BMS with our Cell Therapy team. The Senior Director, Quality Control provides senior leadership of the QC Department, comprised of QC Analytical, ... of 8+ years of increasing management responsibility of a cell therapy or related biopharmaceutical Quality Control laboratory. + Must have a minimum of 5… more
- Actalent (Agoura Hills, CA)
- …based assay, potency assay, cytotoxicity, cell line, qc analytical, gene therapy , micro pipetting, quality , qc, cryopreservation, dd PCR About Actalent ... Description: We are seeking a highly motivated Quality Control Associate to join our...assay characterization and qualification and Phase 1 manufacturing for cell therapy - collaborating with internal partners… more
- UT Health San Antonio (San Antonio, TX)
- …manufacturing, testing and release of clinical and investigational cell therapy products. + Prepares quarterly quality reports and present updates ... Quality Manager, Stem Cell Transplant & Cellular Therapy (Multispecialty...to SOPs and policies. + Responsible for the document control system and program records management, including maintenance of… more
- University of Colorado (Aurora, CO)
- …Aurora, CO. As an academic based biotechnology company, ClinImmune Cell & Gene Therapy is committed to providing the highest quality service and support to ... infusions at patient bedside. + Environmental monitoring, supply control and preventative maintenance on all instruments per cGMP...based biotechnology company, ClinImmune Cell & Gene Therapy is committed to providing the highest quality… more
- Bristol Myers Squibb (Summit, NJ)
- …day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy , this is work that transforms the lives of patients, and ... Bristol Myers Squibb we are reimagining the future of cell therapy . With our bold ambition, backed...activities. The person will collaborate with SMEs, user groups, quality groups, and other stakeholders to accomplish successful implementation… more
