- Merck & Co. (Durham, NC)
- …a timely manner.Responsible for equipment reliability and uptime for the production support, drug substance , and drug product areas. Actively monitors ... strategic maintenance and reliability projects. The Mechanical Services Engineer Associate Director (AD) position will ensure reliable performance of equipment by… more
- Fujifilm (Holly Springs, NC)
- **Position Overview** The Director , Drug Substance Manufacturing (DSM) plays a critical role in the design, execution, and leadership of DSM Operations ... * Ensures all DSM operations are conducted in compliance with current good manufacturing practice (CGMP), Food and Drug Administration (FDA), Occupational Safety… more
- Fujifilm (Holly Springs, NC)
- **Position Overview** ** Director , QA Drug Substance Operations** Are you a strategic leader with expertise in managing teams of QA professionals and ... and grow in a world-class Quality organization as the Director , QA Drug Substance Operations....2025, we'll open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance … more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- **Job Summary** **** The Associate Director , MSAT - Downstream provides specialized technical leadership and oversight for all downstream manufacturing ... and risk assessment. + Provide expert technical oversight of downstream manufacturing operations at CDMOs, including review of batch records, deviation… more
- Genentech (Holly Springs, NC)
- …Manufacturing (PTM) is responsible for managing all aspects of end-to-end drug substance and drug product manufacturing and supply. From the raw ... Spring, North Carolina. The new site will focus on large volume low cost Drug Product manufacturing (Component Prep & Compounding, Liquid PFS Filling, Automated… more
- Astellas Pharma (Sanford, NC)
- …direct related industry experience. + Familiarity with clinical and commercial pharmaceutical manufacturing operations including Drug Substance and Drug ... typically reports to the Manager, Sr Manager, or Associate Director of Manufacturing . **Responsibilities:** + Responsible for...programs are considered a plus. + Industry experience in Drug Substance and Drug Product… more
- Merck (Wilson, NC)
- …for subject matter expert technical support for distribution and logistics of human health Drug Substance , Drug Product and Finished Goods globally. The ... **Job Description** Reporting into the Director , Logistics and Distribution Technology the Associate ...and commercial human health products including active pharmaceutical ingredients, drug substance , drug product, finished… more
- Fujifilm (Holly Springs, NC)
- …end of 2025, we'll open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, ... **Position Overview** The Associate Director , Cleaning Validation is responsible for leading and...implements, and oversees comprehensive cleaning validation program for multi-product manufacturing suites including Drug Substance ,… more
- Merck (Wilson, NC)
- …(eg temperature monitors). To provide SME guidance in support of small molecule drug substance and drug product container closure systems including ... **Job Description** Reporting into the Executive Director Packaging Technical Operations the Director ...with internal and external stakeholders, such as packaging and manufacturing sites, supply chain, commercialization teams across the end… 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...environment. + Prior experience overseeing and working with external manufacturing and analytical sites + Expertise in chromatographic (HPLC,… more
- Merck (Durham, NC)
- …manner. + Responsible for equipment reliability and uptime for the production support, drug substance , and drug product areas. Actively monitors equipment ... strategic maintenance and reliability projects. The Mechanical Services Engineer Associate Director (AD) position will ensure reliable performance of equipment by… 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 , Regulatory Affairs is a pivotal role providing...Manages regulatory activities such as Site Master File, 3.2.A.1, Drug Master Files, and customer filing + Administers company… more
- Fujifilm (Holly Springs, NC)
- …end of 2025, we'll open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, ... **Position Overview** The Director , Operational Excellence is responsible for driving continuous improvement initiatives and promoting Lean Sigma methodologies… more
- Fujifilm (Holly Springs, NC)
- …end of 2025, we'll open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, ... **Position Overview** The Associate Director , QA for Materials, Supply Chain and QC...processes for operational readiness objectives and QA support of manufacturing operations in cGMP regulated facility including trend reports… more
- Genentech (Holly Springs, NC)
- …Technical Operations (PT) is responsible for managing all aspects of end-to-end drug substance and drug product manufacturing and supply. From the raw ... The new site will focus on large volume low cost Drug Product manufacturing . **The Opportunity:** As the Head of Qualification/Validation you are initially… more
- Genentech (Holly Springs, NC)
- …Technical Operations (PT) is responsible for managing all aspects of end-to-end drug substance and drug product manufacturing and supply. From the raw ... North Carolina. The new site will focus on large volume low cost Drug Product manufacturing . **The Opportunity** As the Head of Quality Control (QC) you are… more
- Cambrex High Point (High Point, NC)
- …leading global contract development and manufacturing organization (CDMO) that provides drug substance , drug product, and analytical services across the ... partner in branded and generic markets for API and dosage form development and manufacturing . Your Work Matters. At Cambrex, we strive to build a culture where all… more
- Amgen (Holly Springs, NC)
- …patients while transforming your career. Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch ... Batch facility will not only feature the best in-class drug substance manufacturing technologies with...The Specialist QC Support will report directly to the Director of Quality Control and as a member of… more
- Fujifilm (Holly Springs, NC)
- …end of 2025, we'll open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, ... ensure a fit-for-purpose network architecture scaled for a large manufacturing plant. This role functions as a local extension...of the Global IT team reporting into the Sr. Director - IT. This role ensures local implementation and… more
- Fujifilm (Holly Springs, NC)
- …end of 2025, we'll open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, ... ensure a fit-for-purpose network architecture scaled for a large manufacturing plant. This role functions as a local extension...of the Global IT team reporting into the Sr. Director - IT. This role ensures local implementation and… more
