Manager/Sr. Manager/Associate Director, CMC Operations
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 studies for prostate cancer, and the second product HPN536 is in clinical development in ovarian cancer and other tumors that over-express mesothelin. Harpoon has two additional products in pre-clinical development that will be introduced 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 and from the public market. The company emphasizes a collegial, collaborative environment and has a strong record of scientific innovation, pioneering protein engineering, expertise in tumor immunology and pre-clinical and clinical research.
We are seeking a highly motivated employee to join Harpoon’s current CMC team to assist in execution of technical operations to insure robust and continued supply of Harpoon clinical candidates to clinical sites. Areas of responsibility include drug substance and drug product production management, stability study design and management, interfacing with Harpoon and vendor quality assurance functions, and alignment of CMC activities with corporate goals. 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.
- Work with the Product Development and Quality Assurance teams in the management of all aspects of CMC development and manufacturing including oversight of development and production at external drug substance and drug product manufacturing CMOs
- 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
- Selection of new vendors through a Request for Proposal process when needed
- Integration of new vendors into ongoing or new programs
Skills and Qualifications
- B.S., M.S., or Ph.D. Degree in biology, biochemistry, chemical engineering, or related field
- Minimum 7 – 9 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
- 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