- Actalent (Fall River, MA)
- …skill testing * Working knowledge of raw materials testing and release * Lead investigation activities. * Ensure compliance to all data integrity and cGMP practices, ... as assigned by the Head of the Department or Section Head Skills Hplc, Gmp , Karl Fisher, Particle size, icp, gc-ms, quality control, raw material, data entry, Wet… more
- Takeda Pharmaceuticals (Lexington, MA)
- …life-cycle management, technology transfer and process characterization and validation. You will lead or contribute as a key member of various cross- functional ... cell culture process development, scale-up and scale-down, tech transfer and GMP manufacturing support. + Have experience in design-of-experiment (DoE) and the… more
- Bristol Myers Squibb (Devens, MA)
- …careers.bms.com/working-with-us . **Responsibilities:** + Support the operations on all GMP manufacturing systems (Process Automation System) in the Manufacturing ... Facilities in Devens, MA. + Lead as well as participate in automation engineering initiatives...+ Experience on automation validation (DeltaV, MES, PI) in GMP environment that includes test script generation and execution.… more
- Catalent Pharma Solutions (Chelsea, MA)
- …Quality Assurance, Quality Control and batch release within a pharmaceutical GMP environment required; + Leadership experience supervising a team of ... and changing deadlines; + Ability to be assertive to ensure appropriate GMP and business standards are achieved + Demonstrable leadership experience at Catalent… more
- Astellas Pharma (Westborough, MA)
- …functionality. This role will work closely with the assay transfer technical lead . This role will mentor junior analysts and develop and facilitate training ... degree with 4+ years of relevant experience in a GMP Quality Control role + Prior laboratory hands-on experience...a supportive and positive work environment, strong knowledge of GMP , SOPs and quality control processes, and strong knowledge… more
- Bristol Myers Squibb (Devens, MA)
- …industry best practices and regulatory expectations for cleaning validation. + Lead and support projects involving new product introductions, equipment changes, or ... laboratories, consultants, and equipment/cleaning agent vendors. + Based in a GMP -regulated manufacturing or laboratory environment. + May require working in… more
- Medtronic (Danvers, MA)
- …Radiation Dose Audits (Gamma and Ebeam). Leverage Good Manufacturing Practices ( GMP ), Aseptic Technique, Laboratory Information Mgmt. System (LIMS), Good Laboratory ... Chambers, Sterilization adoptions, and Radiation Dose Audits (Gamma and Ebeam); GMP , Aseptic Technique, LIMS, GLP, and Environmental Monitoring; Product sampling for… more
- Curia (Boston, MA)
- …patients' lives. The Director, Analytical Development will provide technical leadership and lead a team of analytical scientists in support of biologics clinical ... + Proven track record of leading analytical development in a GMP -regulated environment and collaborating with operations and Quality teams. + Demonstrated… more
- Hologic (Marlborough, MA)
- …Hologic's commitment to excellence by ensuring compliance with Good Manufacturing Practices ( GMP ), ISO standards, and quality systems, while fostering a culture of ... continuous improvement and collaboration. **What to expect:** + Lead with Ownership - Demonstrate integrity and always aim to do the right thing. Be highly… more
- Hologic (Marlborough, MA)
- …and other global regulatory requirements. + Expertise in Quality Systems and GMP compliance in regulated industries such as medical devices or pharmaceuticals. + ... degree in Life Sciences, Engineering, Medical, or related field. + Lead Auditor certification and qualifications for relevant regulations. + ISO 13485:2016… more