- Fujifilm (Holly Springs, NC)
- …opportunity for you to lead and grow in a world-class Quality organization as the Director , QA Drug Substance Operations. In this role, you will ... **Position Overview** ** Director , QA Drug Substance Operations**...Science, Process Engineering, Validation, and Automation + Ensures the quality assurance ( QA ) review and… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- **Job Summary** **** The Associate Director , MSAT - Downstream provides specialized technical leadership and oversight for all downstream manufacturing processes ... processing. + Collaborate closely with Upstream MSAT, Validation MSAT, QA , Regulatory, Process Development, Analytical Development, and CDMO technical teams.… more
- Fujifilm (Holly Springs, NC)
- …open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one ... **Position Overview** The Associate Director , QA for Materials, Supply Chain...and QC team which includes release of materials, Supplier Quality program and support for QA for… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …Analytical Development** + Lead and oversee phase appropriate method development and optimization for drug substance and drug product at CDMOs + Design and ... lead method validation and implementation activities for drug substance and drug product...analytical team members, process chemistry, formulation development, regulatory affairs, quality assurance , and other departments to drive… more
- Genentech (Holly Springs, NC)
- …Pharma Technical Manufacturing (PTM) is responsible for managing all aspects of end-to-end drug substance and drug product manufacturing and supply. From ... new site will focus on large volume low cost Drug Product manufacturing (Component Prep & Compounding, Liquid PFS...or operations + You have vast knowledge of safety, quality systems and quality assurance … more
- Genentech (Holly Springs, NC)
- …Pharma Technical Operations (PT) is responsible for managing all aspects of end-to-end drug substance and drug product manufacturing and supply. From ... new site will focus on large volume low cost Drug Product manufacturing. **The Opportunity** As the Head of...or operations. + You have extensive knowledge of safety, quality systems and quality assurance … more
- Genentech (Holly Springs, NC)
- …Pharma Technical Operations (PT) is responsible for managing all aspects of end-to-end drug substance and drug product manufacturing and supply. From ... new site will focus on large volume low cost Drug Product manufacturing. **The Opportunity:** As the Head of...or operations. + You have extensive knowledge of safety, quality systems and quality assurance … more
- Cambrex High Point (High Point, NC)
- …submission of CAPA plans, Change Requests, and Deviations in coordination with the Associate Director , Quality Assurance + Author and Revise Quality ... in GXP/ QA /regulatory compliant pharmaceutical laboratory environment or Quality Assurance /Regulatory Affairs role (prefer late phase/commercial experience).… more
- Astellas Pharma (Sanford, NC)
- …or Filling. The incumbent will work with cross functional teams including Quality Assurance , Process Engineering, Supply Chain, and Manufacturing. The Senior ... experience. + Familiarity with clinical and commercial pharmaceutical manufacturing operations including Drug Substance and Drug Product operations and… more
- Amgen (Holly Springs, NC)
- …while transforming your career. Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility ... The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but… more