Principal Scientist - Process Development & Manufacturing
Greater LA Area
Competitive Compensation + excellent bonus/benefits
Duties and Responsibilities:
- Lead upstream process development, downstream operations, and process engineering
- Oversee internal (upstream & downstream activities), domestic & international vendors
- Provide strategic oversight for several programs from discovery, early-stage development, commercialization, and Launch
- Support R&D/CMC, Manufacturing, Quality Operations and Business Development/Commercial
Qualifications:
- Experience working cross functionally with senior leadership (QC, Analytical, Manufacturing, Regulatory, Business Development, etc. )
- Experience leading Continuous Process Verification, Process Validation, Material Qualification, & Regulatory Submissions
- Experience overseeing outsourced vendors (CDMOs) and internal R&D activities
- Expert authoring and strategically working on IND - BLA/MAA submissions
- M.S or Ph.D. in Bioengineering/Chemical Engineering or a related scientific field w/ ideally 10 or more years of industry experience