Associate Director, CMC Development
Catalyst Biosciences is currently seeking a motivated scientific leader to join our CMC team as our Associate Director, CMC Development. The ideal candidate will play a key role in the planning, coordination, and execution of drug substance and drug product development.
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.
- Individual contributor responsible for technical leadership of drug substance and drug product development and manufacturing activities in support of early-stage development program
- Apply scientific expertise to design and implement innovative solutions for development of complement factor proteins to address key challenges and support project deliverables on accelerated timelines
- Independently designs, oversees, interprets and presents results from studies to proactively make recommendations for decision making and influence the direction of CMC development strategies and activities
- Partner with internal and external stakeholders to develop and implement CMC plans in support of broader project team and organizational goals
- Manage relationships with CDMOs, CROs and key suppliers including coordination, communication and technical oversight, to meet accelerated timelines and ensure timely delivery of cGMP supplies to support clinical trials
- Serve as primary point of contact to the CMOs to provide technical oversight for cell line development, process development, formulation development, analytical method development and qualification, batch manufacture and testing, stability studies, deviation investigation, batch review and release of cGMP material
- Generate high quality data based on sound scientific principles and prepare data summaries, technical reports, scientific presentations and regulatory documents
- Collaborate with internal and external stakeholders to support project plans and schedules, ensuring that tasks are executed in accordance with operational plans, cGMP requirements and regulatory commitments
**Title/Level to commensurate with education and experience.
- PhD or Masters degree in a scientific discipline (e.g., Chemical Engineering, Biochemistry, or related field)
- PhD with a minimum of 5 years’ experience in a development environment or MSc with a minimum of 8 years’ experience in early-stage clinical development
- Highly experienced in one or more of the following areas: cell line development, process development, formulation development and/or analytical method development and qualification
- Technical expertise in early-stage clinical development and cGMP manufacture of recombinant mammalian and microbially produced biologic products
- Strong understanding and expertise in development and scale up of microbially produced recombinant proteins (experience with refolding of insoluble proteins is highly preferred).
- Sound knowledge and understanding in process development, formulation development, and analytical characterization of PEGylated and fusion proteins is desirable.
- Demonstrated ability to work effectively in a team-oriented CMC environment and successfully influence others in cross-functional teams
- Demonstrated ability to effectively manage CDMOs globally
- Excellent communication skills (interpersonal, written and verbal)
- Must be well organized, proactive, detail-oriented, mature and professional
- Ability to multi-task and work efficiently in an environment with changing priorities
- Experience in a fast-paced environment