Manager/Sr. Manager/Associate Director, CMC Program Management
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 provide integrated CMC project management from initial API supply through clinical supply chain. Areas of responsibility will include coordination of drug substance, drug product, and ancillary product testing vendors, timeline management and reporting, and alignment of CMC activities with corporate goals. This individual will report into the SVP, Product Development and play an essential role in overseeing and coordinating activities at contract research and manufacturing organizations.
- Work with the Product Development and Quality Assurance teams to assist in 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)
- Sample management and tracking to insure proper shipping, storage, and receipt of product at testing or production sites
- Tracking of results/conclusions/next steps for each program at each vendor
- Assisting in budget development and management for all outsourced activities
- Streamlining communication and program organization
Skills and Qualifications
- B.S. or M.S. Degree in biology, biochemistry, chemical engineering, or related field
- Minimum 4 - 7 years industry experience in program management of clinical biopharmaceutical development and manufacturing
- Experience working with external vendors (Contract Manufacturing Organizations, GMP testing facilities, etc)
- Experience managing project timelines and overall project coordination
- Excellent verbal and written communication, strong organizational and interpersonal skills
- Ability to work in a dynamic, fast-paced, timeline-based environment