- Gilead Sciences, Inc. (Foster City, CA)
- …late-phase portfolio. + Support the design/justification/execution of end-to-end control strategy development through a proactive definition of the product ... & Manufacturing (PDM) and partner with Quality, Supply Chain, Manufacturing, CMC Regulatory Affairs, Clinical Development and Technical Development … more
- Lilly (Indianapolis, IN)
- …Regulatory, CMC PM) and external CDMOs to align and execute the CMC development plan. + Create and update end-to-end capacity models, provide important ... around the world. **Overview:** We are seeking a Senior Director , ADC Process Development , to lead and...IND/IMPD/BLA submissions and regulatory interactions. + Deep understanding of CMC workflow, process development and scale-up, tech… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and early clinical phases. + CMC awareness: Understanding of drug substance/ product development and manufacturing timelines. + Possess strong business acumen ... the broader Pharmaceutical Development and Manufacturing (PDM) organization, the **Senior Director , Product Management Team Lead** will lead a team of … more
- AbbVie (Irvine, CA)
- … programs (or one large, complex program) in support of the overall product development plan, based on strong medical and scientific principles, knowledge ... by program needs, in partnership with Discovery, Translational, and CMC colleagues contribute to design and implement translational strategies....OD, MD, PharmD) preferred. *At least 8 years of product development experience with 5 years of… more
- Lilly (Indianapolis, IN)
- … cycle (proof of concept) to product commercialization + Experience in development / CMC including quality and regulatory interactions is expected + ... purification, isolation, and formulation. The position presents an opportunity to lead CMC activities to support clinical trials, product commercialization, and… more
- Otsuka America Pharmaceutical Inc. (Salem, OR)
- …including sample collection, storage conditions, and analytical testing, to support product development and regulatory submissions. + Author and review ... **Associate Director , Small Molecule Analytical Development ** +...development and optimization for drug substance and drug product at CDMOs + Design and lead method validation… more
- Sumitomo Pharma (Lincoln, NE)
- …FDA and ICH regulations/guidance documents specific to clinical research and general product development in the pharmaceutical industry + Experience reviewing ... with a minimum of 4 years focused in regulatory affairs + Oncology product development experience preferred + Experience contributing to electronic regulatory… more
- Lilly (Indianapolis, IN)
- …Design and Development (SMDD) need for drug substance and drug product development , characterization, and supply of material for toxicology and clinical ... new medicines that will help solve our world's greatest health challenges. In Product Research and Development (PRD), we transform molecules into medicines. Our… more
- Astrix Technology (Olmsted County, MN)
- …to market! **Location:** Olmsted County **Principal Responsibilities** + Drive and oversee product development activities at the site, ensuring robust, scalable ... ** Director of Pharmaceutical Development ** Clinical Olmsted...+ Minimum of 5 years of experience in pharmaceutical/biotech product development involving small molecules, peptides, or… more
- Takeda Pharmaceuticals (Brooklyn Park, MN)
- …to the best of my knowledge. **Job Description** **About the role** As Associate Director , Drug Product Manufacturing Science & Technology, you will be Takeda's ... pharmaceutical development and manufacturing. + Deep expertise in drug product manufacturing technologies for oral solid dosage forms and/or injectable products,… more