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.

Responsibilities

  • 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

Qualifications/Skills Required

  • 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:
    • Leadership
    • Drive, Intensity, Enthusiasm
    • Goal Orientation/Commitment to Task/Follow-up
    • Teamwork
    • Attention to Quality & Detail
    • Decision Making & Problem Solving
    • Flexibility
    • Ownership & Accountability

Thank you for your interest in Catalyst Biosciences! You may apply for this position by sending your CV/resume to jobs@catbio.com, referencing requisition number AC20-207 in the subject line.