- 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 ... diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Proficient 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 ... Biotech is seeking a QA Warehouse Incoming Raw Material Specialist as part of the Quality team based in...to manufacturing of cell -based products is required Knowledge… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …position will be responsible for metrology support for cGMP Clinical and Commercial Cell Therapy Manufacturing . This individual will partner with various ... of multiple myeloma. Legend Biotech is seeking a Metrology Specialist as part of the Maintenance & Metrologyteam based...Operation functions in support of personalized cell therapy production through safe and compliant manufacturing … more
- Aequor (Seattle, WA)
- …the Learning Management System (LMS). The position will report to the Global Cell Therapy Quality Training Lead REQUIRED COMPETENCIES: Knowledge, Skills, and ... for department metrics. Maintain class offerings in the LMS Ensure Good Manufacturing Practices training records are completed per good document principals (GDP).… more
- Aequor (Seattle, WA)
- …Specialist supports the cGMP Document Control operations for the Client Cell Therapy Above-site organization, including the document approvals, document ... Primary responsibilities include: Managing an electronic document system for the Cell Therapy Above-Site which includes reviewing and approving document… more
- Aequor (Bothell, WA)
- …MES construct. MS Windows Server and SQL server also a plus. Experience with cell therapy or other biopharmaceutical manufacturing . Other highly regulated ... SCOPE OF POSITION (Position Summary): The MES Recipe Engineer and Validation Specialist role will deliver electronic batch record (EBR) configuration and validation… more
- Bristol Myers Squibb (Bothell, WA)
- …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...organization is pivotal in upholding quality standards within aseptic manufacturing , with core competencies in Microbiology and Chemistry. Our… more
- MD Anderson Cancer Center (Houston, TX)
- …position is to manage the department of Stem Cell Transplantation and Cellular Therapy (SCTCT) Cell Therapy Laboratory (CTL) Quality Management Plan and ... the creation of SOP, policies, forms and labels; review product manufacturing records; conduct quality investigations, audits, and risk assessments; investigate and… more
- ThermoFisher Scientific (Frederick, MD)
- **Job Description** **Position Summary:** The Technical Sales Specialist (TSS) for ( Cell Culture/ Cell Therapy , Pharma Analytics, Purification, Single Use ... for complex opportunities + Attends technical collaboration visits to Business Unit manufacturing and R&D sites + Provides post-sales product support, follows up on… more
- MD Anderson Cancer Center (Houston, TX)
- …various clinical trials that may differ from standard operating procedures of MDACC Cell Therapy Laboratory. Must adhere to all defined processing and ... saving cellular products used for treatment of cancer patients undergoing Stem Cell Transplantation and/or Cellular Therapy treatment. **The ideal candidate will… more
- Bristol Myers Squibb (Summit, NJ)
- …validation deliverables for S12 Enterprise Manufacturing Execution System (EMES) used in cell therapy manufacturing . This role is primarily an individual ... no better place than here at BMS with our Cell Therapy team. The ** Specialist **...responsible for ensuring the validation of the S12 Enterprise Manufacturing Execution System (EMES), and applications are done following… more
- United Therapeutics (Eden Prairie, MN)
- …of pharmaceutical and biotechnology regulations and industry standards + Working knowledge of cell therapy manufacturing and product release At United ... and kidney disease. How you'll contribute The Senior QA Specialist - GMP Manufacturing , is responsible for supporting quality operations during GMP clinical… more
- University of Southern California (Los Angeles, CA)
- …scientific field. Demonstrated knowledge of all aspects of biotechnology and cell therapy . Demonstrated passion for solving complex scientific issues. ... field(s) Preferred Skills: Demonstrated knowledge of all aspects of biotechnology and cell therapy . Demonstrated passion for solving complex scientific issues.… more
- University of Pennsylvania (Philadelphia, PA)
- …the Director in laboratory management, and lead multiple research projects related to cell and gene therapy , and contribute to the development and implementation ... standard operating procedures (SOPs) critical for modifying and upscaling cell products in preparation for clinical manufacturing ....management, and collaborative research efforts in the field of cell and gene therapy . The ability to… more
- WuXi AppTec (Philadelphia, PA)
- …**WuXi Advanced Therapies** is a leading global cell and gene therapy contract, testing, development, and manufacturing organization (CTDMO) that is ... Banks and performing activities within production facilities to support manufacture of Cell and Gene Therapy products, and final products fills according to… more
- Astellas Pharma (Westborough, MA)
- …--both embryonic and induced pluripotent stem cells as well as other cell -based therapy research programs. AIRM is headquartered in Massachusetts. Astellas ... is announcing a Compliance Specialist opportunity at our Astellas Institute of Regenerative Medicine...with management in advance. GMP Operations at AIRM support cell culture manufacturing platforms, which naturally run… more
- Astellas Pharma (Westborough, MA)
- …--both embryonic and induced pluripotent stem cells as well as other cell -based therapy research programs. AIRM is headquartered in Massachusetts. Astellas ... is announcing a **Compliance Specialist ** opportunity at their **Astellas Institute of** **Regenerative Medicine...with management in advance. GMP Operations at AIRM support cell culture manufacturing platforms, which naturally runs… more
- Editas Medicine (Cambridge, MA)
- …the Principal Specialist , you will be responsible for: + Support Editas' clinical cell manufacturing facilities in Waltham, MA and Devens, MA as a member of ... verbal and written communication skills required. + Understanding of regulatory guidance on cell and gene therapy products. + Expertise working within cGMP… more
- Editas Medicine (Cambridge, MA)
- …the Senior Specialist , you will be responsible for: + Supporting Editas' clinical cell manufacturing facilities in Waltham, MA and Devens, MA as a member of ... analysis investigations. + Demonstrated expertise understanding/interpreting regulatory guidance on cell and gene therapy products. Preferred Qualifications:… more
- Charles River Laboratories (Memphis, TN)
- QA Release Specialist III Req ID #: 221971 Location: Memphis,...the job description. The Memphis site is a CDMO cell therapy manufacturing site. + ... that you can feel passionate about. **Job Summary** The QA Release Specialist III is responsible for performing various Quality Assurance activities related to… more
