- Fujifilm (Holly Springs, NC)
- **Position Overview** The Associate Director , QA for Materials, Supply Chain and QC will be responsible for the supervision of the Quality teams supporting ... reports, deviations, and changes coming from the QC function. Assures product compliance through Quality systems and effectively ensure initiatives that promote… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …which require cross-functional interactions for commercial or investigational product (s). Examples include meeting requests, briefing packages, original ... Investigational New Drug (IND), IND amendment, and routine submissions (eg, Development...associated information updates and maintenance in accordance with the product license for assigned products and markets. + Critically… more
- AbbVie (North Chicago, IL)
- …patient counseling. Ensure physical and electronic security controls for the pharmacy, drug inventory and pharmacy records. + Defines the boundaries of accepted risk ... resolve service failures or persistent problems. Partner and align with Compliance Director and Privacy Officer to facilitate/ensure compliance to HIPAA and address… more
- Organon & Co. (Plymouth Meeting, PA)
- …The Label Strategist is accountable for developing and maintaining the target product labeling for developmental products, the core labeling documents (CCDS) and US ... and US labeling, including associated patient labeling documents, and the target product labeling. The Label Strategist is also responsible for supporting local… more
- Bristol Myers Squibb (Devens, MA)
- …Lead matrix teams in the preparation of environmental risk assessments to support drug product registrations and chemical registrations worldwide + Plan, monitor ... and passionate team that is focused on being a world class Product Stewardship group within Bristol Myers Squibb's Environment, Health, Safety and Sustainability… more
- Sanofi Group (Cambridge, MA)
- …**Key Responsibilities:** + Lead a team that works with internal partners in Drug Product development, Biopharmaceutics and Analytical to select the API physical ... API processes that are closely coordinated with API route selection and Drug Product development. + Digital Development - Lead the transformation of development… more
- WuXi AppTec (Boston, MA)
- …Manager will be responsible for managing projects within STA, WuXi's API, and Drug Product development and manufacturing division. Leads the orderly progression ... industry experience, preferably in API process R&D and manufacturing and/or Drug Product R&D and manufacturing. + Prior experience in project management or… more
- Bristol Myers Squibb (Summit, NJ)
- …help patients are incredible. We are looking for a Process Engineer to join the drug product team within the Cell Therapy Technical Operations (CTTO) team. CTTO ... Therapy Manufacturing Processes across the manufacturing network throughout the product life-cycle from pre-clinical through commercial manufacturing. The Sr.… more
- Lilly (Indianapolis, IN)
- …and external technical/quality networks. + Strong understanding of cGMPs and drug product manufacturing. + Excellent communication skills, with attention ... processes and critical parameters align with regulatory submissions throughout the product lifecycle. + Maintain compliance with cGMPs, regulatory commitments, and… more
- Bristol Myers Squibb (Princeton, NJ)
- …the early work, additionally exploring mechanisms of response/non-response, rational drug combinations and product differentiation. The late-stage translational ... a department within the Research organization that facilitates the transition of drug candidates from early to late-stage clinical development, their approval and… more