- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …standards. Lead responses to Health Authority questions and deficiency letters. + Represents CMC RA in project team meetings and provides expert interpretation ... of regulatory guidelines and perspective to the cross-functional team. Serve as CMC regulatory lead on global project teams (Pharmaceutical Development, Quality,… more
- BeOne Medicines (Emeryville, CA)
- …implement small molecule CMC regulatory strategies as well as authoring CTD CMC sections for the assigned project to ensure on-time and high-quality global ... throughout product life cycle. Escalate the critical issues to senior management timely. + Lead or contribute to development...product complaints arise during product lifecycle for the assigned project . + Provide CMC regulatory review for… more
- BeOne Medicines (Emeryville, CA)
- …commercial negotiations, defining responsibilities between BeiGene and the CMO. Act as project manager of the contract negotiation with close partnership with ... **General Description:** The Senior Procurement Manager of CMO Category...with contract manufacturers (CMOs) worldwide, Commercial Supply Chain, CMO Project Managers, Alliance Managers, Quality and CMC … more
- 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 ... 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)
- …and transform the lives of patients while transforming your career. **Process Development Senior Scientist** **What you will do** Let's do this. Let's change the ... Amgen's Commercial Attribute Sciences group in Thousand Oaks, California is seeking a Senior Scientist. The successful candidate will join us on our effort to… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units as needed. Works ... the associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units as needed. - Works… more
- Gilead Sciences, Inc. (Foster City, CA)
- … Director, Product Management Team Lead (Early Phase) will have experience serving as project manager for early phase biopharma molecules and will serve as a ... 35 countries worldwide, with headquarters in Foster City, California. ** Senior Director,** **Product Management** **Team** **Lead** **(Early Phase)** **_Location:… more
- Stantec (Sacramento, CA)
- …and industry experience to consistently produce project deliverables that meet project requirements and the project manager and client's expectations. ... plumbing. Your Key Responsibilities - With direction from a project manager and/or Professional Engineer Design, develop,...as part of a coordinated design team. - Assist senior engineers in the design and development of mechanical… more
- Gilead Sciences, Inc. (Foster City, CA)
- …day and improving the lives of patients for generations to come. As a Senior Research Associate at Gilead you will + Plan and successfully execute experiments and ... working environment, and continuous improvement + Help support key project or department stakeholders as needed to ensure that...as well as identity and report inconsistent results to manager or supervisor + Participate in group meetings and… 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