Senior Scientist, Drug Substance Development & Manufacturing
We are currently seeking to hire a motivated Senior Scientist, Drug Substance Development & Manufacturing with Purification and Drug Product experience to join our CMC team. The ideal candidate will play a key role in the planning, coordination, and execution of drug substance and drug product development at the CMOs.
About Catalyst Biosciences
Catalyst is a clinical-stage biopharmaceutical company focused on developing novel treatments for hemophilia and other rare bleeding disorders using our potent, subcutaneous (SQ) coagulation factors that promote prophylaxis therapy. We have completed the Phase 2 trial of our subcutaneous (SQ) Factor VIIa (FVIIa) variant Marzeptacog alfa (activated) (MarzAA) for prophylaxis. The study met the primary endpoint of significantly reducing the annualize bleed rate (ABR) in patients with hemophilia A or B with inhibitors. The study also met all secondary endpoints of safety, tolerability and lack of anti-drug antibody or inhibitor formation. We have also initiated enrollment in a Phase 2b trial of Dalcinonacog alfa – DalcA, a next-generation (SQ) administered Factor IX (FIX) therapy being developed for the treatment of hemophilia B.
- Responsible for supporting drug substance/purification and drug product manufacturing activities
- Managing relationships with CMO’s and key suppliers including coordination and technical oversight, to ensure timely delivery of cGMP products to support clinical trials
- Review batch records, development protocols and reports
- Supporting documentation for batch manufacture and testing, while providing trouble-shooting support as well as root cause analysis for deviations
- Prepare formulation data summaries, technical reports, scientific presentation and regulatory documents. As well as preparation and review of CMC sections of regulatory filing
- Analyze/interpret process data and write technical protocols and reports
- Review batch release and stability data and trend process performance
- Ph.D. or Masters in Life Sciences of Chemical Engineering
- Ph.D. with 4-5 years or Masters with 8+ years of direct experience in Biologics, Process Development, CMC, MSAT and manufacturing.
- Drug Substance/Purification and Drug Product Experience (Biologics)
- Experience with upstream and downstream Process Development including UF/DF, formulation and bulk fill.
- Late stage Process Development Experience (Phase III to BLA) is preferred.
- 4-5 years Experience working with or part of a Process Transfer or MSAT Team
- Experience with Tech Transfer and Process Scale Up for recombinant proteins is highly desirable
- Working and maintaining relationships with CMO’s, DS, DP
- Flexible, adaptive attitude, ability to problem solve, multitasker, resilient with a positive outlook.