Careers

Manager, CMC Operations

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 Manager, CMC Operations to play a key role in contributing to complex and intertwined CMC - related activities at preselected contract research and manufacturing organizations.

key Responsibilities

  • Provide support to technical operations including management of vendors used for biopharmaceutical manufacturing of Harpoon’s cutting edge clinical stage products
  • Coordinate product and test method transfer from Harpoon to CMOs and CROs and assist in providing reagents and information to CMOs and CROs as needed
  • Manage documents and forms for shipping and testing of all Harpoon products throughout the manufacturing of drug substance and drug product
  • Assist in alignment of timelines between vendors
  • Contribute in tracking all activities
  • Participate in review of cGMP documentation
  • Assist in preparation or review of IND and other regulatory submissions

skills and Qualifications

  • BS, MS, or Ph.D. in biology, biochemistry, chemical engineering, or related field 
  • Minimum 3 years industry experience in biopharmaceutical development and manufacturing
  • Experience in outsourcing and vendor management essential
  • Excellent verbal and written communication, strong organizational and interpersonal skills
  • Ability to work in a dynamic, fast-paced, timeline-based environment