Principal Contract Manufacturing Drug Product Scientist (TK19-204)

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 have completed the Phase 2 trial of our subcutaneous (SQ) Factor VIIa (FVIIa) variant marzeptacog alfa (activated) (MarzAA) for prophylaxis. The study met the primary endpoint of significantly reducing the annualize bleed rate (ABR) in patients with hemophilia A or B with inhibitors.  The study also met all secondary endpoints of safety, tolerability and lack of anti-drug antibody or inhibitor formation.  We have also initiated enrollment in a Phase 2b trial of dalcinonacog alfa – DalcA, a next-generation (SQ) administered Factor IX (FIX) therapy being developed for the treatment of hemophilia B.

We are currently seeking to hire a motivated Principal CM Drug Product Scientist who would report to the Senior Director of Contract Manufacturing Drug Product.

Responsibilities

  • Manage relationships with Drug Product 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 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
  • Participate in preparation and review of CMC sections of regulatory filings
  • Provide trouble-shooting support as well as root cause analysis
  • Liaison for all 3rd party CMOs and CROs
  • Write and review batch record analysis and interpretations
  • Travel globally as required to CMO, CRO and key vendor sites to represent Catalyst Biosciences for Manufacturing oversight and partnership development purposes

Qualifications/Skills Required

  • MSc or PhD in pharmaceutical sciences, chemical engineering, analytical sciences or equivalent field with 0-3 years of experience or BS/MS degree with 8-10 years of relevant experience in the biotechnology or pharmaceutical industry
  • Technical expertise in development and full-scale manufacture of recombinant mammalian biologic products
  • A strong technical background encompassing protein chemistry, analytical development, and formulation development is required
  • Deep understanding and expertise with drug product manufacturing
  • Prior experience with aseptic processing, and drug product manufacture processes transfer is preferred
  • 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, polished, 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 start-up 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 TK19-204 in the subject line.