- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …commercial product quality to ensure global supply for Otsuka's patients. **Job Description** + Provides Biologics QA support for Drug Substance and Drug ... The Senior Manager, Global Product Quality - Biologics is responsible for managing quality oversight of...analysis. + Thorough understanding of GMP requirements and the Drug Development process. + Knowledge of FDA… more
- Takeda Pharmaceuticals (Lexington, MA)
- …mammalian upstream and/or downstream drug substance process development , ideally with exposure to commercial-scale biologics manufacturing. + Experience ... for multi-site products. You will ensure that complex, multi-site biologics drug substance processes are...and Life Cycle Management (LCM) projects. + Collaborate with Biologics Process Development on process improvements and… more
- Takeda Pharmaceuticals (Boston, MA)
- …and downstream), process technology transfer and support of clinical manufacturing of drug substance (DS) using mammalian cell or related expressions systems. ... on programs with complex business deliverables. + Operational experience in pharmaceutical drug development with significant direct exposure to clinical … more
- Actalent (Waltham, MA)
- …experience in validation, process development , and CAPA investigations. + Experience with drug substance , drug product, and biologics manufacturing. ... Validation Specialist - Biologics (Relocation Offered!) Are you passionate about driving...a key role in ensuring compliance and excellence across drug substance and drug product… more
- Takeda Pharmaceuticals (Lexington, MA)
- …experience in pharmaceutical or biopharmaceutical development /manufacturing, with substantial exposure to biologics Drug Substance and Drug Product. ... Lead** and drive **high-impact, high-visibility CMC projects for innovative biologics in a dynamic global environment.** You will provide...You will own the end‑to‑end CMC lifecycle for both Drug Substance and Drug Product,… more
- ThermoFisher Scientific (Waltham, MA)
- …development and manufacturing organization (CDMO) offering end-to-end services for drug development , clinical trial logistics, and commercial manufacturing! ... our speed, flexibility, and quality across every phase of drug development . With worldwide locations, we support...market today and drive the future of healthcare! Our Drug Substance team supports customers in the… more