Principal Scientist, Formulation Development (AC20-207)
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.
We are currently seeking a motivated Principal Scientist with formulation development experience to join our technical operations team. The ideal candidate will play a key role in the planning, coordination and execution of drug substance and drug product development.
- 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.