- 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
- 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... Product manufacturing. **The Opportunity:** As the Head of Quality Assurance you are initially accountable for… 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
- Fujifilm (Research Triangle Park, NC)
- …+ Navigates regulatory complexities and differences across microbial, mammalian, commercial, clinical, drug substance , and primary and secondary packaging at the ... **Position Overview** The Director , QA Regulatory Affairs is a...Manages regulatory activities such as Site Master File, 3.2.A.1, Drug Master Files, and customer filing + Administers company… 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
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