Role Overview
We're looking for a Director, Drug Product (DP) MSAT to define and lead our Manufacturing Sciences and Technology strategy for biological drug products. In this role, you'll serve as the senior technical authority for contract drug product and fill-finish manufacturing, setting the strategic and technical direction for external manufacturing partners across new product introductions, technology transfers, process performance, and complex issue resolution.
About Abcellera
Each of us cares about someone who will need medicines. That’s why our vision is to repeatedly beat the odds to deliver breakthrough medicines to patients who need them. We pursue truth and scientific rigour and have the courage to work at the edge of the unknown.
Key Responsibilities
- Serving as the senior subject matter expert for DP/fill-finish manufacturing processes and technologies
- Directing technology transfer of drug product manufacturing processes to external manufacturing facilities
- Owning final review and approval of CDMO cGMP batch documentation
- Driving process performance improvement in close collaboration with internal and external teams
- Authoring and approving DP technical reports
- Directing the development of sampling plans for cGMP batches
Requirements & Eligibility
- 15+ years of industry experience in DP development and manufacturing of monoclonal and/or bispecific antibodies
- Bachelor's degree in science or engineering discipline; device and combination product experience a plus
- Outstanding command of the scientific and technical principles underlying drug products and aseptic fill-finish operations for vial and prefilled syringe presentations
- Deep knowledge of GMP requirements, pharmaceutical manufacturing regulations, and validation and qualification principles
- Significant experience in pre-formulation and formulation methods supporting pre-clinical and clinical programs
Required Skills & Tech
cGMPDrug Product ManufacturingTechnology TransferProcess Characterization