- 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
- 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)
- 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
- 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
- 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)
- … 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
- 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
- Bristol Myers Squibb (San Diego, CA)
- …the design, development, and advancement of RayzeBio's radiopharmaceutical programs. This senior role is responsible for driving innovative research in novel isotope ... into robust clinical drug products. The Sr. Scientist will lead CMC radiopharmaceutical process development, oversee IND-enabling activities, and play a pivotal… more