- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- The Senior Manager , Global Product Quality - Biologics is responsible for managing quality oversight of clinical and commercial products at CMOs under contract by ... of regulatory submissions for OPDC R&D products. Performs quality reviews of CMC sections of regulatory submissions. + Authors and maintains Standard Operating… more
- Amgen (Thousand Oaks, CA)
- …such as Drug Substance Technologies, Drug Product Technologies, Product Quality, Regulatory CMC , and Supply Chain. The successful candidate will actively chart the ... opportunities to advance their own career in partnership with their manager . **Key Responsibilities Include:** + Lead analytical method lifecycle management… more
- Bristol Myers Squibb (San Diego, CA)
- …into robust clinical drug products. The Sr. Scientist will lead CMC radiopharmaceutical process development, oversee IND-enabling activities, and play a pivotal ... Other duties may be assigned. + Process Development & Scale-Up: Drive CMC process development and optimization for clinical drug products, including formulation lock… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Senior Director, Product Management Team Lead (Early Phase) will have experience serving as project manager for early phase biopharma molecules and will serve as ... **KEY RESPONSIBILITIES** Reporting to the Executive Director of Product & Project Management and operating within the broader Pharmaceutical Development and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …needed + Participates in solving issues of high complexity. + Communicates issues to line manager and project teams in a timely manner + Support product team ... medical devices. + Strong computer skills and experience with an ERP system and project management software + Understanding of activities related to the CMC … more
- AbbVie (Irvine, CA)
- …(TPP), Asset Plan and PDP, tracking progress in conjunction with the Portfolio Project Manager , with attention to committed timeline and budget. + Ensures ... Discovery, Development Sciences, Operations, Commercial, Market Access, Regulatory, Safety, Project Management, Medical Affairs, etc., and substantial cross-functional interaction… more
- Astrix Technology (San Diego, CA)
- …and day-to-day operations within the QC department + Report directly to the CMC Expert Manager **Qualifications:** + Master's degree in Chemistry (Bac+5); ... and guidelines (eg, BPF, ICH-Q7, ISO 13485, US/EU Pharmacopeia) + Proven project management skills and ability to meet ambitious milestones + Detail-oriented with… more
- Gilead Sciences, Inc. (Foster City, CA)
- …mindset, matrix working environment, and continuous improvement + Help support key project or department stakeholders as needed to ensure that company objects are ... as well as identity and report inconsistent results to manager or supervisor + Participate in group meetings and...fields with 2+ years of industrial experience in biologics CMC development + Hands on experience working with biologic… more