Associate Director/Director, Formulation Development (AC20-207)
We are currently seeking a motivated Associate Director/Director, Formulation Development to join our technical operations team in South San Francisco HQ. 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 driving drug product formulation activities
- Manage relationships with CMOs, CROs and key suppliers including coordination, communication and technical oversight and ensure timely execution of deliverables
- Serve as primary point of contact to the CMOs to support formulation development and stability studies
- Generate high quality data based on sound scientific principles and prepare formulation 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
- PhD in a scientific discipline with a minimum of 5 years’ experience in formulation development or MSc with a minimum of 10 years’ experience in process development
- Technical expertise in process development and analytical characterization of recombinant mammalian and microbially produced biologics
- Strong understanding and expertise in formulation development of pegylated proteins is highly desirable.
- Prior experience with aseptic processing and drug product manufacture processes transfer is preferred
- Demonstrated ability to work effectively in a team-oriented CMC environment
- ·Excellent communication skills (interpersonal, written and verbal)
- Must be well organized, proactive, detail-oriented, mature and have a professional demeanor
- Ability to multi-task and work efficiently in an environment with changing priorities
- Experience in a fast-paced environment
- Demonstrated skills in Catalyst’s Core Competencies:
- Drive, Intensity, Enthusiasm
- Goal Orientation/Commitment to Task/Follow-up
- Attention to Quality & Detail
- Decision Making & Problem Solving
- Ownership & Accountability
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 (AC20-207) in the subject line.