- MSD Malaysia (Boston, MA)
- …Coordinate with CROs, CDMOs, and clinical sites to support cGMP manufacturing logistics and clinical supply/distribution for radiopharmaceuticals. Manage ... clinical studies, including collaboration with academic sites and contract partners for cGMP manufacturing.* Experience as imaging lead on Phase I oncology trials… more
- Takeda (Boston, MA)
- …molecule process development activities. Understanding of current Good Manufacturing Practices ( cGMP ) Knowledge and Skills: Analytical and Problem Solving Skills - ... Able to troubleshoot critical issues or problems, and determine causes and possible solutions. Teamwork -- Ability to work well in highly cross functional team environment and across global line functions. Communication Skills -Able to expresses one's self… more
- BioSpace (Boston, MA)
- …molecule process development activities. Understanding of current Good Manufacturing Practices ( cGMP ). Knowledge And Skills Analytical and Problem Solving Skills - ... Able to troubleshoot critical issues or problems, and determine causes and possible solutions. Teamwork - Ability to work well in a highly cross functional team environment and across global line functions. Communication Skills - Able to express oneself… more
- Bristol Myers Squibb (Devens, MA)
- …ensure compliance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP . The Manager, Shop Floor Quality Assurance, Cell Therapy is responsible ... accordance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP . Functional responsibilities include ensuring operational compliance with applicable… more
- Bristol Myers Squibb (Devens, MA)
- …are technically sound, promote effective and efficient operations, and comply with cGMP requirements + Training others on SOPs, Work Instructions to successfully ... global Health Authority requirements. **Knowledge, Skills, Abilities:** + Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy… more
- Bristol Myers Squibb (Devens, MA)
- …product into cryogenic shipper for shipment to patient **Documentation** + Complete CGMP forms and/or paper/electronic batch records + Perform SAP transactions as ... 6AM); Panama schedule to cover 24-7-365 operations + Operate in a commercial CGMP multi-product environment + Job requires standing and walking within and between… more
- Element Materials Technology (Acton, MA)
- **Overview** Join Element's Acton laboratory, a cGMP -certified, FDA- and DEA-registered facility specializing in microbiology, environmental monitoring, and ... and regulatory standards + Ensure all quotes comply with internal policies, cGMP requirements, and applicable accreditations (eg, ISO/IEC 17025) + Maintain and… more
- ThermoFisher Scientific (Plainville, MA)
- …grade biopharmaceuticals, qualification/validation of analytical methods for support of cGMP manufacturing, and the transfer and validation of assay methods ... from clients and/or Assay Development & Analytics to the cGMP QC testing laboratory. The manager ensures cGMP... cGMP QC testing laboratory. The manager ensures cGMP compliance, operates within budgets, and supervises bioanalytical lab… more
- Bristol Myers Squibb (Devens, MA)
- …for cell therapy manufacturing in accordance with Current Good Manufacturing Practices ( cGMP 's). + Work closely with department SME's to align on procedural updates, ... in a Biotechnology/Pharmaceutical Manufacturing Operations or Support role. Knowledge of cGMP and manufacturing production is preferred. Experience authoring cGMP… more
- Catalent Pharma Solutions (Burlington, MA)
- …development, commercial operations + 5+ years of direct operational experience in cGMP manufacturing of cell-based therapies or experience in supporting customers in ... the cGMP space. + Expertise in cGMP ecosystem support functions (process development, analytical assay development and MS&T) is a plus. + Extensive customer… more
