Senior Director, Biologics Drug Substance Manufacturing

Catalyst Biosciences has an exciting opening and is seeking a Senior Director of Biologics Drug Substance Manufacturing. This impactful position will report to the SVP of Biologics Development and Manufacturing and has primary responsibility for managing the Contract Manufacturing Organization (CMO) activities including process development, process improvements, technology transfers, scale up and clinical manufacturing of drug substance compounds. Catalyst Biosciences is advancing several high potency parenteral recombinant compounds, targeted for subcutaneous delivery, through preclinical to late stage clinical trials with the intent of commercializing.

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

• Manage relationships with Drug Substance CMOs, CROs and key suppliers including coordination, communication and technical oversight, to ensure timely delivery of cGMP products to support clinical trialsServe as primary technical and operational point of contact to the CMOs to support batch manufacture and testing, deviation investigation, batch review and release of GMP material
• Collaborate with CBIO Project Management and CMOs in developing project plans and schedules and ensure that tasks are executed according to the operational plans, Development & Master Services Agreement, cGMP requirements and regulatory commitments
• Lead manufacturing development activities, technology transfer and scale-up of process improvements with our CMO partners and our business collaborators.
• Participate in preparation, review and approval of CMC sections of regulatory filings
• Provide technical recommendations for assay development / validation, evaluating process data, trouble-shooting and root cause analysis as well as providing strategic recommendations leading to improved yields, cost of goods and process robustness
• Support additional development activities and subsequent technology transfer and manufacturing of the drug substance, as needed
• Arrange and oversee shipments of cell lines, drug substance and associated samples to third party warehouses, CRO and drug product CMOs
• Liase and work with third party CROs for characterization testing of the drug substance
• Travel globally as required to CMO, CRO and key vendor sites to represent Catalyst for Manufacturing oversight and partnership development purposes
• Partner with key Catalyst functions including Quality, Project Management, Clinical Operations, Preclinical, Finance and Regulatory Affairs

**Title/Level to commensurate with education and experience.

Requirements

• PhD in Chemical/Biochemical Engineering, Biochemistry, Chemistry or Biology with a minimum of 10 years in the biotech/pharmaceutical manufacturing environment
• Direct experience with managing internal recombinant mammalian and microbial GMP manufacturing activities required
• Proven success in global CMO management with recombinant mammalian and microbial commercial and clinical products required
• Technical expertise in development and full-scale manufacture of recombinant mammalian and microbial biologic products. Direct experience working with recombinant Factor drug substance is preferred.
• Demonstrated ability to work effectively in a team-oriented CMC environment
• Ability to effectively manage vendors globally
• Excellent communication skills, both written and oral