Associate Director, CMC Development (AC20-208)
We provide ample scientific challenges enabling you to have a real impact in an environment where you get the opportunity to take part in the entire biotech value chain from the earliest drug discovery all the way through late stage clinical development. We expect you to bring an innovative mindset, scientific curiosity, a lot of energy and pragmatism.
We are 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 medicines to address important unmet needs within bleeding and complement related disorders. Catalyst has compounds that span the value chain from the earliest discovery to late stage clinical trials with the intent of commercialization.
- Senior-level individual contributor responsible for supporting drug substance and drug product manufacturing activities
- Manage relationships with CMOs, CROs and key suppliers including coordination, communication and technical oversight, to ensure timely delivery of cGMP products to support clinical trials
- Serve as primary point of contact to the CMOs to support batch manufacture and testing, stability studies, deviation investigation, batch review and release of GMP 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
- Provide trouble-shooting and root cause analysis support
- Liaison for all 3RD party CMOs and CROs
- PhD in a scientific discipline with a minimum of 5 years’ experience in a development environment or MSc with a minimum of 10 years’ experience in early-stage clinical development will be considered
- Technical expertise in development and full-scale manufacture of recombinant mammalian and microbially produced biologic products
- Strong understanding and expertise in development and scale up of microbially produced recombinant proteins (especially in refolding of insoluble proteins is highly preferred).
- Sound knowledge and understanding in process development and analytical characterization of pegylated proteins is desirable.
- Demonstrated ability to work effectively in a team-oriented CMC environment
- Ability to effectively manage vendors 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
Thank you for your interest in Catalyst Biosciences! You may apply for this position by sending your CV/resume to email@example.com, referencing requisition number (AC20-208) in the subject line.