- 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
- Bristol Myers Squibb (Devens, MA)
- …in a manner consistent with the safety policies, quality systems, and cGMP requirements. + Completing training assignments to ensure the necessary technical skills ... to a new startup facility. **Knowledge, Skills, Abilities:** + Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing… more
- Nitto Denko Corp. (Milford, MA)
- …of assigned production operations working within defined production schedules in a cGMP environment. Key Responsibilities: + May specialize in either purification or ... May act as a lead for any given campaign. + Review of basic cGMP documentation including solution and raw material reconciliation. + Develop, review and revise SOPs… more
- Bristol Myers Squibb (Devens, MA)
- …are executed in accordance with Current Good Manufacturing Practices ( cGMP 's). **Shifts Available:** TBD **Responsibilities:** + Supporting the development, ... the patients by compliance with company procedures and policies, and cGMP requirements. + Efficiently coordinating, communicating, and providing Operations project… more