Associate Director/Director, CMC Outsourcing

Location
South San Francisco, California
Posted
Aug 20, 2018
Required Education
Bachelors Degree
Position Type
Full time

Description

Harpoon Therapeutics is an early-stage biotech company located in South San Francisco. The Company is developing biologics with novel molecular formats to engage and activate immune cells for the treatment of cancer and other diseases. With multiple programs positioned to enter clinical development in the next two years, we are evolving into a clinical stage company. We are seeking a highly motivated Assoc. Director/Director of CMC Outsourcing to execute CMC/technical operation activities. This individual will report into the SVP, Product Development and play an essential role in managing complex and intertwined CMC - related activities at preselected contract research and manufacturing organizations.               

Key Responsibilities

  • Manage all aspects of outsourced development programs including arranging and monitoring drug, reagent, and packaging supplies and insuring our contractors receive materials as needed
  • Alignment of timelines within each vendor and among different vendors along the supply chain (i.e., drug substance manufacturing and drug product manufacturing sites)
  • Coordination of review of documentation including development reports, data, and cGMP documentation including batch records, quality standards, protocols, and release documentation
  • Tracking of results/conclusions/next steps for each program at each vendor
  • Selection of new vendors through a Request for Proposal process when needed
  • Integration of new vendors into ongoing or new programs
  • Streamlining communication and program organization 

Skills and Qualifications

  • B.S., M.S., or Ph.D. Degree in biology, biochemistry, chemical engineering, or related field 
  • Minimum 7-10 years industry experience in biopharmaceutical development and manufacturing
  • Experience working with external vendors (Contract Manufacturing Organizations) essential
  • Experience managing biopharmaceutical CMC activities critical
  • Familiarity with managing stability programs, data review and storage, and budgets a plus
  • Experience managing analytical and formulation development would be a plus
  • Excellent verbal and written communication, strong organizational and interpersonal skills
  • Ability to work in a dynamic, fast-paced, timeline-based environment