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, the Protease Medicines company

Catalyst is a research and clinical development biopharmaceutical company focused on addressing unmet medical needs in rare disorders of the complement and coagulation systems. Our protease engineering platform has generated two late-stage clinical programs, including MarzAA, a subcutaneously (SQ) administered next-generation engineered coagulation Factor VIIa (FVIIa) for the treatment of episodic bleeding in subjects with rare bleeding disorders. Our complement pipeline includes a pre-clinical C3-degrader program partnered with Biogen for dry age-related macular degeneration, an improved complement factor I protease for SQ replacement therapy in patients with CFI deficiency and C4b-degraders designed to target disorders of the classical complement pathway as well as other complement programs in development.

Responsibilities

• 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

Requirements

• 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.