SVP, Product Development and Manufacturing
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.
Reporting into Harpoon’s Chief Scientific Officer, the SVP of Product Development and part of our executive management team, you will be responsible for developing and implementing a phase-appropriate CMC strategy for each of Harpoon’s clinical candidates and for overseeing day to day CMC-related activities at multiple vendors. This role will serve as the company and external representation for clinical and commercial technical development. You will also be responsible for Harpoon’s Protein Science group, which is tightly integrated into clinical candidate assessment and selection, as well as bench-scale process and formulation development. The ideal candidate will be a highly experienced and dynamic leader who can oversee all CMC aspects of our clinical programs and can develop appropriate strategies to support later stages of clinical development and commercialization. The successful candidate will mentor, develop and empower other product development team leads to grow, learn, and successfully manage the company’s growing pipeline.
- Establish and execute Harpoon’s product development strategy in a product and phase appropriate manner.
- Lead the day-to-day operations of the CMC , Protein Science, and Supply Chain organization, demonstrating leadership, management skill, and scientific expertise in directing external vendors who provide drug substance and drug product process development and manufacturing, quality control, analytical development, testing, and clinical/commercial supply chain.
- Direct internal personnel and external partners through process development, cGMP Manufacturing Process Scale-Up, change control, and regulatory submissions.
- Manage and direct CMC teams to implement strategies for process risk assessment, characterization, and validation studies, including preparation and review of protocols and reports as well as oversight of study execution conforming to regulatory standards.
- Establish and maintain collaborative partnerships with CDMO partners to achieve project and program goals, ensure product quality, and support the clinical advancement of the Company’s pipeline programs.
- Supervise preparation and manage project timelines and budgets to achieve product development goals.
- Responsible for team oversight and ensuring accurate preparation and approval of technical reports, manufacturing instructions, process validation documents, and other relevant documents at external vendors.
- Responsible for overseeing preparation of Module 3 and other portions of regulatory submissions including initial IND (or equivalent) submissions for new pipeline products, new manufacturing sites or other process changes, and annual reports and updates to active INDs.
- Prepare data, reports, and CMC documents to support regulatory submissions, including BLA planning and submission.
- Ph.D., MS, or applicable scientific degree with 10 + years of relevant experience in biologics process development and manufacturing in the biotechnology industry.
- In depth knowledge and hands on experience in directing and managing outsourced technical and operational product development and manufacturing from production of initial clinical trial material through advancing into later clinical stages.
- Ability to navigate a fast-evolving biotech drug development environment and work across functions to align critical activities in Research/Discovery, Nonclinical, Quality, Regulatory, and Clinical Development to ensure timely program progress.
- Ability to create, lead and foster a collaborative team environment, develop trust, and ensuring transparent communications.
- Negotiate with and influence key stakeholders.
- Effective communication skills in presenting to internal (scientists, PDT members, management, executives, and board of directors) and external (scientific conferences, publications, working groups, and regulatory interactions) audiences.
- Knowledge in regulatory guidance, requirements, and expectations in the US and internationally.