Process Development (Downstream)
Greater San Diego Area
Competitive Compensation + excellent bonus/benefits
Duties and Responsibilities:
- Lead downstream process development(Late-Stage) and tech-transfer activities for Biologics Portfolio (mAb & proteins)
- Supervise/Mentor staff in Downstream PD
- Set strategy for process scale-up, FMEAs, process robustness and characterization studies, process validation, and regulatory filings
- Support R&D, commercial, manufacturing, quality assurance and business development departments
Qualifications:
- Experience working cross functionally with senior leadership (QC, Analytical, Manufacturing, Regulatory, Business Development, etc. )
- Past experience overseeing outsourced vendors (CROs/CMOs/CTLs/CDMOs) and internal R&D activities
- Past experience having late stage process development studies.
- M.S or Ph.D. in Pharmaceutical Sciences or a related scientific field with ideally 5-7 years of industry experience
