Manager/Sr. Manager, Clinical Supply Chain
Harpoon Therapeutics (ticker: HARP) 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 Harpoon plans to initiate a Phase 1/2 trial in the second half of 2020. 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 employee to join Harpoon’s current Product Development team to assist in execution of clinical supply chain operations to ensure robust and continued provision of Harpoon clinical candidates, diluents, and ancillary supplies to clinical sites. Areas of responsibility include coordination between product development and clinical operations, alignment of supply chain activities with individual program and corporate goals and assisting with shipments and documentation related to providing clinical supplies to sites for all clinical programs.This individual will report to the Associate Director, Clinical Supply Chain and play an essential role in managing complex supply chain operations across multiple clinical programs.
- Supervision and monitoring of Harpoon supply chain vendors, including logistics, timing, documentation, and project management
- Develop clinical study supply plans and maintain active inventory tracking for investigational drug products and ancillary equipment in compliance with company's internal procedures and GxP requirements
- Establish packaging designs based on protocol and manage all packaging activities including work order creation, review of contractor packaging records prior to and after packaging operations, and monitoring work at contractors to ensure uninterrupted clinical supply at clinical sites globally
- Work with Product Development to anticipate and project supply chain requirements and to ensure that new drug product lots are produced and released in time to meet clinical demand
- Review and approval of internal Harpoon packaging and labelling release documentation in coordination with Harpoon Quality Assurance
- Coordinate investigational product shipping and logistics activities including management of shipments between storage/distribution depots and to clinical trial sites
- Coordinate courier deliveries and manage courier relationship as needed.
- Review temperature logs related to investigational product distribution and storage, and investigate temperature deviations according to established procedure
- Actively communicate supply plan progress to all stakeholders. Build and maintain positive working relationships with co-workers and functional areas to accomplish project objectives
- Participate on clinical sub-teams and provide clinical supply updates and summaries as needed
Skills and Qualifications
- B.S. or M.S. Degree in biology, biochemistry, chemistry, or related field
- Minimum 3 years industry experience in supporting early and/or late phase clinical supply chain
- Experience working with external drug supply vendors (labeling, packaging, and distribution vendors, CROs etc.) is essential
- Experience with design, testing, implementation and monitoring of IxRS is desirable
- Experience with global distribution and QP release for clinical testing in EU countries a plus
- Excellent verbal and written communication, strong organizational and interpersonal skills
- Ability to work in a dynamic, fast-paced, timeline-based environment