Associate Director/Director, Drug Product Manufacturing
SOUTH SAN FRANCISCO, CA
Harpoon Therapeutics is a clinical-stage immunotherapy company located in South San Francisco. Harpoon Therapeutics is a clinical-stage immunotherapy company developing a novel class of T cell engagers that harness the power of the body’s immune system to treat patients suffering from cancer and other diseases. T cell engagers are engineered proteins that direct a patient’s own T cells to kill target cells that express specific proteins, or antigens, carried by the target cells. Using its proprietary Tri-specific T cell Activating Construct (TriTAC®) platform, Harpoon is developing a pipeline of novel TriTACs initially focused on the treatment of solid tumors and hematologic malignancies. HPN217 targets BCMA and is in a Phase 1/2 trial for relapsed, refractory multiple myeloma. HPN328 targets DLL3 and is in a Phase 1/2 trial for small cell lung cancer and other DLL3-associated tumors. HPN536 targets mesothelin and is in a Phase 1/2a trial for cancers expressing mesothelin, initially focused on ovarian and pancreatic cancers. Harpoon has also developed a proprietary ProTriTAC™ platform, which applies a prodrug concept to its TriTAC platform to create a therapeutic T cell engager that remains inactive until it reaches the tumor. The company’s third proprietary technology platform, extended release TriTAC-XR, is designed to mitigate cytokine release syndrome. Harpoon is led by an experienced management team. 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. For additional information about Harpoon Therapeutics, please visit www.harpoontx.com.
We are seeking a highly motivated individual to join Harpoon’s CMC team to manage drug product manufacturing operations for multiple products to ensure robust and continued supply of Harpoon clinical candidates to clinical sites. Areas of responsibility include identification, evaluation and selection of drug product CDMOs, management and oversight of operations at these CDMOs, critical review of batch production records, coordinating scheduling with those for drug substance and clinical labeling and packaging and interfacing with the project team to ensure that clinical supply needs are met. Reporting into the SVP, Product Development and Manufacturing, this individual will play an essential role in managing complex and intertwined CMC-related activities at contract research and manufacturing organizations.
- Identify, evaluate and select drug product CDMOs
- Manage and provide oversight of operations at drug product CDMOs, including act a person-in-plant during manufacturing activities
- Perform critical review of batch production records and SOPs
- Work with other technical experts and QA to facilitate the closure of any deviations and investigations that may arise.
- Forecast, schedule, and track manufacturing activities. Represent drug product functions and activities in Product Development Team meetings. Coordinate with CMC project manager to integrate drug product manufacturing schedule with those for drug substance and clinical labeling and packaging to ensure that clinical supply needs are met
- Support drug product batch release related activities that require details from CDMO information
- Assist in GMP audits of facilities for all clinical development programs.
- Support drafting and updates to pertinent CMC sections of regulatory filings.
- Participate in and support ongoing business development and clinical partnering efforts.
- B.S., M.S., or Ph.D. in biology, biochemistry, chemical engineering, or related field.
- 8-10 years industry experience in managing early and/or late phase clinical biopharmaceutical manufacturing, at least some of this as drug product, ideally working with protein biologics.
- Familiarity with CDMO manufacturing operations for biologics is essential.
- Experience selecting and working with external vendors (CDMOs, GMP testing facilities, etc.) and budget management is a plus
- Excellent verbal and written communication, strong organizational and interpersonal skills
- Experienced in use of MSOffice suite, including Word, Excel, Powerpoint. Familiar with project tracking using MSProject.
- Ability to work in a dynamic, fast-paced, timeline-based environment