- Bristol Myers Squibb (San Diego, CA)
- …programs at RayzeBio. This role will help to drive the CMC radiopharmaceutical process development for RayzeBio's novel pipeline. The radiopharmaceutical development ... scientist will assist with the CMC development plan and IND enabling activities, leading to...clinical drug product specifications and manage the execution of CMC studies. **Responsibilities:** Essential duties and responsibilities include the… more
- Butler America (Chula Vista, CA)
- …and in some cases create, MS Project Plans for R&D Ceramic Matrix Composite ( CMC ) and Prognostic Health Monitoring (PHM) projects. . Gather data to update plans, ... The Following - Create, as necessary, and maintain R&D CMC and PHM project plans weekly Facilitate and drive...up to 3 times per week in association with CMC and PHM projects Standardized visuals such as TRL… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …ensure compliance with applicable regulations and guidelines. + Provide CMC functional representation on wider cross-functional program development teams, ensuring ... all CMC considerations are accounted for in wider clinical development...in wider clinical development plans. + Serve as early-stage CMC representative of the department in effectively communicating program… more
- Gilead Sciences, Inc. (Foster City, CA)
- …+ Lead collaborations with Gilead PDM functions such as Quality Assurance, CMC Reg, Manufacturing and Technical Operations, Product and Portfolio Management, Finance ... regulatory filings by guiding the draft, review, and approval of CMC sections; support associated agency interactions and product-related inspections + Provide… more
- Gilead Sciences, Inc. (Foster City, CA)
- …the Product Strategy Team, Manufacturing, and Analytical functions, Supply Chain, RA CMC , and the wider PDM Quality organization. The successful candidate must have ... and ensure visibility and communication of strategy, key project timelines and CMC milestones. + Monitor and review cross-functional process and product data to… more
- Gilead Sciences, Inc. (Foster City, CA)
- …this role leads strategic cross-functional teams responsible for all technical and CMC aspects of the assigned products, from entry into the technical development ... teams to ensure effective and timely progression of pipeline projects and CMC life-cycle planning. Develop and own the product technical plan including timelines,… more
- BeOne Medicines (Emeryville, CA)
- …initiatives with Contract Manufacturers (CMO) + In partnership with Quality, CMC , Procurement, Supply Planning to ensure manufacturing performance, cost objectives ... production & continuity of supply + Partner with internal stakeholders such as CMC , Regulatory, Quality to ensure on time commercial launch & new market launch… more
- Rolls-Royce (Cypress, CA)
- …location: Cypress, CA As a Manufacturing Engineer for Ceramic Matrix Composites ( CMC ), you will provide technical support to operations and execute manufacturing ... Science, Technology or Engineering, OR + 6+ years' experience in Manufacturing Engineering or CMC Manufacturing experience in lieu of a degree + In order to be… more
- ThermoFisher Scientific (San Diego, CA)
- …to lead multiple stability programs with moderate to high complexity within CMC . + Coordinates communication with internal customers and external vendors. + ... including audit functions, as needed. + Serves as a stability lead for a CMC project team or a working group. + Assists in method development and validation… more
- Kelly Services (Thousand Oaks, CA)
- …development. + Collaborate cross-functionally with chemistry, biology, in vivo, and CMC teams to ensure integrated data flow for decision-making. **Qualifications & ... BioPharma Finder, or vendor-specific platforms. + Familiarity with early-stage CMC analytical needs, including assay qualification. + Knowledge of bioanalytical… more