- 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
- Kelly Services (South San Francisco, CA)
- Kelly(R) Science & Clinical is seeking an Associate Director / Director of Drug Substance Manufacturing for a direct hire opportunity with a leading ... San Francisco, CA, 3 days/week. **Position Title:** Director of Drug Substance Manufacturing **Position Type:** Direct hire **Salary:** Director ,… more
- Lilly (Indianapolis, IN)
- …including Mounjaro. The Sr Director leads technical aspects of drug substance manufacturing including process optimization, technical transfers ... US and global regulations + Understanding the scientific principles required for manufacturing intermediates and drug substances, including the interaction of… 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. (Harrisburg, PA)
- **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
- Lilly (Indianapolis, IN)
- …organization, responsible for leading global technical teams in the successful transfer of drug substance and dry oral products (including SDD) processes across ... communities through philanthropy and volunteerism **Position Summary:** The Senior Director of TSMS - Tech Transfer is a strategic...node to node transfers of commercial products across the drug substance and dry products portfolio. +… more
- Alamo Group Inc. (Winn, MI)
- …of the company and is the champion for driving continuous improvements in lean manufacturing and safety. The Director of Operations reports directly to the ... **Position Summary:** The Director of Operations works closely with the President...or expression, disability or veteran status. We maintain a drug -free workplace and perform pre-employment substance abuse… more
- Gilead Sciences, Inc. (Foster City, CA)
- …environment and collaborate across diverse technical areas. + Experience with Biologics Drug Substance manufacturing equipment and processes, Single-Use ... their aspirations. Join Gilead and help create possible, together. **Associate Director , Manufacturing Operational Readiness** Gilead Sciences is seeking a… more
- Genentech (Hillsboro, OR)
- … Drug Product Manufacturing including all unit operations such as drug substance thawing, filtration, filling, lyophilization and crimping for vial and ... **The Position** Hillsboro Technical Operations (HTO) is a drug product & finished goods manufacturing ...is a drug product & finished goods manufacturing organization responsible for the reliable delivery of Roche's… more
- Boehringer Ingelheim (Ridgefield, CT)
- …guidance, EU and FDA drug manufacturing regulations as related to drug substance . + Excellent written and oral communication and negotiating skills. + ... EACD for drug product develops non-traditional BI CMC project strategies for drug substance and drug product development accessed through external… more
- Boehringer Ingelheim (Ridgefield, CT)
- …guidance, EU and FDA drug manufacturing regulations as related to drug substance + Excellent written and oral communication and negotiating skills + ... employees. **Duties & Responsibilities** + Lead and manage all drug substance (DS) and drug ...substance route scouting, process research, process development and manufacturing , solid state/crystallization, and cGMPs + Active in internal… 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 . Astellas Pharma Inc. is...programs are considered a plus. + Industry experience in Drug Substance and Drug Product… more
- Merck (West Point, PA)
- …for subject matter expert technical support for distribution and logistics of human health Drug Substance , Drug Product and Finished Goods globally. The ... **Job Description** Director , Packaging Shipping Systems (Logistics and Distribution Technology)...and commercial human health products including active pharmaceutical ingredients, drug substance , drug product, finished… more
- Merck (Rahway, NJ)
- **Job Description** **Join Our Team as a Biologics** ** Drug Substance & Cell Banking Leader** **!** Are you ready to take your career to the next level? We are ... seeking a dynamic and visionary Biologics Drug Substance & Cell Banking Leader to...and drive innovation in biologics DS & cell bank manufacturing and commercialization projects. **Why You'll Love This Role:**… more
- Lilly (Indianapolis, IN)
- …in process or automation engineering **Additional Information** + This position supports Lilly's drug product and drug substance network globally and may ... determined to make life better for people around the world. **Associate Director - Digital Engineering Solutions** **Organization Overview:** At Lilly, we serve an… more
- Merck (West Point, PA)
- …characterization assays to inform process development and release and characterize drug substance and drug product. The Director reports to the Executive ... and ensure safety and quality of our products. The Director of Vaccines Potency in Analytical Research & Development...process development, drug substance and drug product release, extended characterization, and clinical manufacturing… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …strategy, clinical supply manufacturing and distribution, network strategy, brand strategy, drug substance manufacturing , vector manufacturing , ... Supply (GPS) business units, and will report to the Senior Director ; Manufacturing Optimization Analytics. The Manager will develop advanced data analytic tools… more
- Endo International (Horsham, PA)
- …coordination and delegation responsibility for the planning of drug product, drug substance manufacturing , combination product, and packaging activities, ... Office and building presentations & analytical tools. + Experience with biological drug substances preferred. + Experience with sterile manufacturing preferred.… more
- Lilly (Indianapolis, IN)
- …the technical leadership and execution of analytical efforts for the commercial development of drug substance and/or drug product processes. Our team is ... implementation of technical solutions and analytical strategies to enable drug substance process or drug ...manufacturing partners to deliver robust control strategies for drug substances, drug products, and/or drug… more