VP of CMC
Harpoon Therapeutics is a clinical-stage immunotherapy company located in South San Francisco. The company is developing novel biologics that harness the power of the body’s immune system to treat patients suffering from cancer and other diseases. Using its proprietary Tri-specific T cell Activating Construct (TriTAC® ) platform, Harpoon is developing a pipeline of novel T cell engagers 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, pancreatic cancers and mesothelioma. 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-expressing 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 microenvironment. 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. Reporting into the SVP of Product Development, the VP of CMC will provide tactical oversight of process development and outsourced manufacturing operations of Harpoon’s portfolio of protein therapeutics from initial IND-enabling production and analysis to commercial readiness.
- Lead a team of internal personnel and external CDMO/CMO partners responsible for process development and manufacturing operations
- Oversee DS and DP process transfer and development, analytical method transfer and implementation, and cGMP manufacturing at contract manufacturing sites.
- Forecast, schedule, and track manufacturing activities.
- Coordinate CMC operations to ensure alignment with all manufacturing plans and timelines for delivery in accordance with clinical demand.
- Manage execution of late-stage readiness development and validation activities for advanced programs
- Evaluate and select CDMO/CMO partners for process and analytical development and manufacturing of new product candidates.
- Assist in development and management of budgets for internal and outsourced technical development and manufacturing operations.
- Work closely with regulatory and technical teams for CMC regulatory submissions sections and contributions.
- Represent CMC functions and activities in Product Development Team meetings and coordinate timelines and activities with the PDTs.
- Participate in and support ongoing business development and clinical partnering efforts for all Harpoon platforms and programs
- Manage internal CMC team activities and coordinate internal and external development, manufacturing, and testing to ensure timely completion and release of all GMP batches
- Assist in managing supply chain including shelf life determinations, documentation, coordination of supply to US and ex-US sites
SKILLS AND QUALIFICATIONS:
- Ph.D., MS, or applicable scientific degree with 15 + years of relevant experience in biologics development in the biotechnology industry.
- Minimum of 3 + years with direct team leadership experience.
- Extensive experience managing outsourced technology transfer, development, and cGMP drug substance manufacturing activities of biopharmaceutical products.
- Experience managing fill/finish (drug product) manufacturing for protein biologics.
- Experience with BLA-enabling late-stage development and commercial readiness for outsourced protein therapeutic DS and DP manufacturing
- Previous contributions to CMC budget development and management would be a plus.
- Excellent verbal and written communication, strong organizational and interpersonal skills.
Please email your CV to email@example.com. A cover letter is welcomed but not required.