- Merck (Rahway, NJ)
- …production with respect to device component manufacture and final assembly of biologic/ drug product with device constituent part. + Lead/ support the ... + Deep and broad working knowledge of pharmaceutical vaccine/biologic/small molecule drug product and process development including regulatory submission and… more
- United Therapeutics (Research Triangle Park, NC)
- …of preclinical studies to ensure the successful submission and approval of a drug product by regulatory agencies. This role will provide scientific insight ... you are** We are seeking a highly motivated Clinical Drug Development Scientist to join our team. You will... Development Associate Director level: + 10+ years of product development experience with hands-on experience managing across Phase… more
- Catalent Pharma Solutions (Kansas City, MO)
- …CMC services for stand-alone and integrated biologics projects. We provide support for drug substance, drug product , and intermediates for both innovator ... **Manager, Drug Enforcement Administration** **Position Summary:** Catalent, Inc. is...service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested… more
- Gilead Sciences, Inc. (Foster City, CA)
- …to agency information requests, the Notified Body Option). + Provide oversight for changes to drug substance and drug product CMC details. + Accountable for ... Expert with Quality representatives at CXO(s) and Gilead Sites. + Support drug substance and drug product technology transfer, and new product launches.… more
- Merck (Rahway, NJ)
- …laboratory to commercial scale, step across boundaries and implement novel innovations during drug product development to enable best science at first filing for ... Knowledge, Duties & Responsibilities for the Director Include:** + Sterile drug product development concepts, tools, and requirements for all dosage forms… more
- Catalent Pharma Solutions (Kansas City, MO)
- …supply reliability for commercial products in compliance with cGMPs + Ensures commercial drug product manufacturing is Ready to Execute (RTE): Authors, reviews ... + Partner with commercial clients as required on technical issues affecting their drug product (s); act as product technical steward on client interactions +… more
- Merck (Rahway, NJ)
- …and late-stage development candidates, including screening and development of robust drug product composition, scalable process, primary packaging, compatibility ... Biochemistry or related discipline **Required Experience and Skills** **:** + Deep drug product development expertise with exposure to all stages and aspects of… more
- Dignity Health (Phoenix, AZ)
- …policies. + Maintain detailed and accurate records of all investigational product activities, including drug accountability logs, temperature monitoring, and ... **Job Summary:** We are seeking a highly organized and detail-oriented **Investigational Drug Pharmacy Technician** to support the operations of our Investigational … more
- Cambrex High Point (Longmont, CO)
- …is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product , and analytical services across the ... applying today! Job Overview Position Summary: The Manager in Drug Substance Manufacturing Operations works in a regulated cGMP...staff to enable the goals of the organization in Drug Substance Manufacturing with a focus on safety, quality,… more
- Lilly (Indianapolis, IN)
- …pharmaceutical ingredients (API) and parenteral manufacturing for future injectable therapies ( Drug Product ). The Corporate DeltaV Automation Engineer - API ... a critical juncture as we tool up to realize the potential of our product pipeline. We are building new processing capabilities around the world, and emphasizing… more