Principal Scientist - Contract Manufacturing

South San Francisco, CA 94080

Posted: 06/20/2019 Employment Type: Direct Hire Industry: Clinical & Scientific Job Number: 15936

Principal Scientist - Contract Manufacturing

South San Francisco, CA
 

We are currently seeking to hire a motivated Principal CMC 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 for Manufacturing oversight and partnership development purposes

Requirements
  • 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

 
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