Stability Program Manager/Senior Manager, CMC Operations
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. HPN424 targets PSMA and is in a Phase 1/2a trial for metastatic castration-resistant prostate cancer. HPN536 targets mesothelin and is in a Phase 1/2a trial for cancers expressing mesothelin, initially focused on ovarian and pancreatic cancers. 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. 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. 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 stability programs for multiple products to ensure robust and continued supply of Harpoon clinical candidates to clinical sites. Areas of responsibility include drug substance and drug product stability study design and management, data entry, review and data management while interfacing with Harpoon and vendor quality assurance functions to provide drug product expiry memos. This individual will report into the Director, CMC Operations in Product Development Group and play an essential role in managing complex and intertwined CMC - related activities at contract research and manufacturing organizations.
- Design stability studies that are compliant with phase appropriate ICH guidelines
- Work with Harpoon’s Contract Manufacturing and Research organizations to develop, review and approve stability protocols
- Monitor all ongoing stability studies to ensure that stability pulls, shipments and testing occur in accordance to the protocols. Develop and maintain a stability tracker.
- Support adjudication of shipment temperature excursions if any.
- Collate data from all ongoing stability studies in stability data tables and generate trend data to enable extension of shelf life. Maintain a comprehensive shelf life overview for all clinical products.
- Generate expiry date assignment/ extension documentation to support clinical operations.
- Work with technical experts and QA to facilitate the closure of any deviations and investigations that may arise on the studies.
- Support QP release related activities that require details on stability studies or contract organization information
- Support updates to pertinent CMC sections of regulatory filings to update stability data tables.
- B.S., M.S., or Ph.D. Degree in biology, biochemistry, chemical engineering, or related field
- Minimum 3 – 9 years industry experience in managing early and/or late phase clinical biopharmaceutical Drug substance or Drug product stability programs
- Familiarity with managing stability programs, data review and storage is essential
- Experience selecting and working with external vendors (Contract Manufacturing Organizations, GMP testing facilities, etc) and budget management is a plus
- Excellent verbal and written communication, strong organizational and interpersonal skills
- Ability to work in a dynamic, fast-paced, timeline-based environment