Clinical Supply Chain Manager
EpizymeFull time Full day
Epizyme, Inc. is a fully integrated commercial-stage biopharmaceutical company committed to its mission of rewriting treatment for cancer and other serious diseases through novel epigenetic medicines. In addition to an active research and discovery pipeline, Epizyme has one U.S. FDA approved product, TAZVERIK™ (tazemetostat), for the treatment of patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma who are not eligible for complete resection. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication is contingent upon verification and description of clinical benefit in an ongoing confirmatory trial. The company is also exploring the treatment potential of tazemetostat in investigational clinical trials in other solid tumors and hematological malignancies, as a monotherapy and combination therapy in both relapsed and front-line disease settings. By focusing on the genetic drivers of disease, Epizyme seeks to match medicines with the patients who need them. For more information, visit www.epizyme.com.
Epizyme has assembled a world-class team with a passion for scientific innovation and a commitment to developing novel epigenetic therapies. Join a dynamic, diverse and fun work environment consistent with Epizyme's cultural attributes for success: camaraderie, collaboration, disciplined, innovative, openness, patient-focused and resilient.
Working in harmony with the Director of Clinical Supply manage all material deliverables as related to drug supplies, including, but not limited to:
- Provide IxRS system maintenance, issue resolutions, and general backup coverage, as necessary.
- Working with the CMO's Maintain inventory levels of packaging and distribution components
- Develop and approve labels and batch records
- Assist in development of SOP's and processes
- Keeping all documentation updated for CTMF
- Maximize inventory utilization and obsolescence management by providing expertise and direction in inventory management related issues, resulting in improved asset turnover
- Function as Clinical Supply point person on assigned projects, including identifying, highlighting, and communicated associated risk
- Work with internal partners in ClinOps, RA and all of PharmSci team to assure alignment on goals and objectives
Education & Requirements:
- Bachelor's degree in Life Science or Business discipline
- Minimum 5 years of supply chain experience in the Pharmaceutical, Biotech, or Medical Device industry
- Understanding of IxRS system set-up and management, with experience managing the inventory and distribution management aspects from design to patient dispensing
- Strong understanding of CTM process from primary packaging to distribution to clinical sites
- Experience in working with CMOs and CROs
- Desirable experience working with Purchase Orders and Invoices
- Strong interpersonal and organizational skills with experience in conflict resolution and negotiations
- Proficiency in all aspects of Microsoft applications (Excel, Word, PowerPoint, etc.)
Epizyme, Inc. is a vibrant, entrepreneurial EEO employer committed to a diverse and dynamic workplace.