Location: Hybrid/Redwood City, CA
Lassen Therapeutics is a therapeutic antibody discovery and development company dedicated to the identification of novel medicines for serious unmet medical needs. We are currently looking for an Associate Director to oversee downstream process development and manufacturing of early and late stage clinical biologics programs. In this role, you will report to our VP, CMC and join our growing, and highly-collaborative team.
Responsibilities:
- Subject matter expert for downstream process development. Working with external vendors to oversee, develop, and optimize downstream unit operations in a phase appropriate manner.
- Technical lead for downstream process tech transfer and manufacturing activities.
- Technical lead for downstream process characterization and PPQ with a risk-based approach.
- Develop experimental plans, oversee execution of experiments, and analyze data using statistical approaches as needed.
- Authors and reviews protocols, reports, batch records, and regulatory documents.
- Presents data and communicate plans at project team meetings.
- Leads troubleshooting and investigation of critical deviations.
- Supports CDMO selection.
- Collaborates with QA, Regulatory Affairs and other functions to generate/manage GMP and regulatory documents.
- Manage budget and accounting for drug substance work.
Key Qualifications:
- MS/PhD in Chemistry, Biology, or Engineering discipline, with 5+ years (PhD) or 12+ years (MS) of related industry experience in biologics drug substance downstream development.
- Subject matter expert in biologics protein purification and downstream process development.
- Experience with large scale chromatography, ultrafiltration, viral inactivation and filtration.
- Experience with late phase downstream process characterization and PPQ.
- Working knowledge of upstream process development is nice to have.
- Experience overseeing external CRO based resources for production of drug substance.
- Experience and familiarity with successful operation in the biologics CMC regulatory environment for early to late-stage development.
- Familiarity and working knowledge of GMP/ICH regulations required with a quality mindset.
- Working knowledge of quality by design and risk management is strongly desired.
- Team oriented professional with excellent organizational, communication, leadership and problem-solving abilities.
- Demonstrated ability to successfully coordinate multiple work streams and development efforts efficiently.
This position is a hybrid, full time, direct hire role.