- Sanofi Group (Swiftwater, PA)
- …recombinant proteins, manufacturing support, Phase 3 clinical material production, CMC strategy development, and new product introductions. Your leadership will ... operations** , with strong understanding of GMP requirements and global CMC projects + Experience leading in **matrix organizations** with cross-functional,… more
- Kelly Services (Malvern, PA)
- …phase changes of API clinical materials per Chemistry, Manufacturing, & Controls ( CMC ) timelines. **New Product Introduction (NPI) Tech Transfers** + Accountable for ... departments + Participate in and/or lead cross-functional meetings with CMC and project team representatives and stakeholders + Lead Process-Fit-to-Plant… more
- Takeda Pharmaceuticals (Boston, MA)
- …as a strategic advisor and technology domain expert for Pharmaceutical Sciences/ CMC scientific and clinical manufacturing informatics and digital solutions + ... business partner leadership role. + Proven track record in delivering enterprise-scale CMC technologies and digital solutions in a GxP-regulated environment. + Deep… more
- Takeda Pharmaceuticals (Lexington, MA)
- …CMO and vendors, works closely with drug product, quality, regulatory , program leadership, etc. and establish strategic working relationships. **Responsibilities:** ... plans as required. + Evaluates impact of decisions across CMC functions. + Makes significant independent contributions to complex...plus. + Proven track record of developing and gain regulatory approval of drug delivery systems a plus +… more
- AbbVie (North Chicago, IL)
- …Science & Technology (PDS&T) is a global organization responsible for all CMC activities related to the development and commercialization of AbbVie's parenteral ... with key Analytical stakeholders across organizations as well as cross-functional CMC business partners in the characterization of biologics compounds and provide… more
- Bristol Myers Squibb (Devens, MA)
- … CMC deliverables, technical team objectives, life-cycle improvements, and regulatory commitments. + Provides technical quality expertise and compliance oversight ... the commercial program (vector, gene editing and cell therapy projects) to ensure regulatory compliance of GMP operations in support of the program.The PQL must… more
- Cambrex High Point (Longmont, CO)
- …will frequently present work internally and externally to clients or regulatory agencies. Responsibilities + Perform multistep organic syntheses, isolation, and ... chemistry and drug substance manufacturing requirements. + Developing experience in GMP/ CMC /ICH guidelines, documentation and execution of batch records in a GMP… more
- Lilly (Indianapolis, IN)
- …in a dynamic environment. We are seeking an experienced, innovative, and motivated CMC Analytical Chemistry Advisor or Senior Advisor to support the development of ... of antibody-drug conjugates, as well as demonstrate familiarity with applicable regulatory requirements and emerging trends in the industry. Provides technical… more
- Sanofi Group (Framingham, MA)
- …support MSAT programs and global manufacturing sites, and to collaborate with R&D/ CMC teams. + Lead complex manufacturing investigation such as large column packing ... manufacturing staff at pilot facility. Work with MSAT and CMC pilot teams to drive the necessary pilot data...Internal and external manufacturing sites + Support Quality and Regulatory during health authority inspection and prepare for supportive… more
- Merck (Rahway, NJ)
- …stages of clinical development, as well as process characterization and regulatory filings for successful commercialization. + Improve upstream processes by ... and problem-solving skills. + Stay updated on the scientific and regulatory landscape; contribute scientifically and build your reputation through conference… more