Senior Director, Contract Manufacturing of Drug Product (AH18-179)

Location
94080, South San Francisco
Posted
Apr 02, 2018
Ref
AH18-179
Hotbed
Biotech Bay
Required Education
Masters Degree/MBA
Position Type
Full time

Catalyst Biosciences is seeking a Senior Director, Contract Manufacturing of Drug Product in their South San Francisco office.  This position will report to the SVP, Technical Operations and have primary responsibility for managing Contract Manufacturing Organization (CMO) activities including process development improvements, technology transfers, scale up and clinical manufacturing of drug product compounds. Catalyst Biosciences is advancing several high potency parenteral recombinant compounds, targeted for subcutaneous delivery, through mid to late clinical trials with the intent of commercializing.

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 technical and operational point of contact to the CMOs to support batch manufacture and testing, stability studies, deviation investigation, batch review and release of GMP material
  • Collaborate with Catalyst Biosciences’ Project Management and CMOs in developing project plans and schedules and ensure that tasks are executed according to the operational plans, Development & Master Services Agreement, cGMP requirements and regulatory commitments
  • Lead manufacturing development, technology transfer and scale-up of process improvements as required at the CMOs
  • Participate in preparation, review and approval of CMC sections of regulatory filings
  • Provide technical recommendations for evaluating process data, trouble-shooting and root cause analysis as well as providing strategic recommendations leading to improved yields, cost of goods and process robustness
  • Support as needed additional development activities and subsequent technology transfer and manufacturing of the drug product
  • Arrange and oversee shipments of drug product and associated samples to 3rd party warehouses and CROs
  • Liase and work with 3rd party CROs for characterization testing of the drug product
  • Travel globally as required to CMO, CRO and key vendor sites to represent Catalyst Biosciences for Manufacturing oversight and partnership development purposes
  • Partner with key Catalyst Biosciences functions including Quality, Project Management, Clinical Operations, Finance and Regulatory Affairs.

Qualifications/Skills Required

  • MSc or PhD in Chemical/Biochemical Engineering, Biochemistry, Chemistry or Biology with a minimum of 12 years in the bio/pharmaceutical manufacturing environment
  • Direct experience with managing internal recombinant mammalian GMP manufacturing activities required
  • Proven success in global CMO management with recombinant mammalian commercial and clinical products required
  • Technical expertise in development and full-scale manufacture of recombinant mammalian biologic products. Direct experience working with recombinant (Factor drug substance is preferred)
  • Demonstrated ability to work effectively in a team-oriented CMC environment
  • Ability to effectively manage vendors globally
  • Excellent communication skills, both written and oral
  • 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