Associate Director, CMC Operations

Location
South San Francisco, CA
Posted
Jun 21, 2019
Required Education
Bachelors Degree
Position Type
Full time

Harpoon Therapeutics is a clinical-stage immuno-oncology company focused on the discovery and development of novel, proprietary bispecific T cell engaging biologic drug candidates for the treatment of various cancers. Harpoon’s first product, HPN424, is in clinical development for prostate cancer, and the second product HPN536 is in clinical testing for mesothelin over-expressing tumors, such as lung, pancreatic and ovarian cancers . Harpoon currently has two additional products in development and intends to introduce these into clinical development by the end of 2020. Harpoon is led by an experienced management team and has raised more than $200 million from leading life science investors. The company emphasizes a collegial, collaborative environment and has a strong record of scientific innovation, pioneering protein engineering, expertise in tumor immunology and clinical research.

We are seeking a highly motivated Assoc. Director of CMC Operations 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 contract research and manufacturing organizations.               

Key Responsibilities

  • Work with the Product Development and Quality Assurance teams to assist in management of all aspects of CMC development and manufacturing including management of external drug substance and drug product manufacturing CMOs
  • Management of project timelines among different vendors along the supply chain (i.e., drug substance manufacturing and drug product manufacturing sites)
  • Participate in authoring and updating product specifications and insure that testing programs are in place across the vendor network to support release, stability, shelf-life extensions, and product safety
  • Assist as needed in 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 5-7 years industry experience in managing early and or late phase clinical biopharmaceutical development and manufacturing
  • Experience selecting and working with external vendors (Contract Manufacturing Organizations, GMP testing facilities, etc) is essential
  • Experience managing project timelines and overall project coordination
  • 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