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Clinical Supply Chain Manager

Company: Epizyme, Inc.
Location: Cambridge
Posted on: May 12, 2022

Job Description:

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 adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma (ES) who are not eligible for complete resection; adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least 2 prior systemic therapies; and adult patients with relapsed or refractory follicular lymphoma who have no satisfactory alternative treatment options. These indications are approved under accelerated approval based on overall response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). 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 . 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. Key Responsibilities: Working in harmony with the Senior 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
  • 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 and Requirements:

    • Bachelor's degree in Life Science or Business discipline
    • Minimum 2-3 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
    • 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.
    • Ability to provide proof of current vaccination from COVID-19 Epizyme, Inc. is a vibrant, entrepreneurial equal employment opportunity employer committed to fostering a diverse and dynamic workplace of multi-generational employees with varied life experiences and perspectives. Epizyme is taking a responsible approach to creating environments that allow us to do what we do best- discovery, development, and commercialization of oncology treatments through the utilization of Epigenetics. As part of our commitment to employee health and safety, COVID-19 vaccines are required for all U.S. salaried and hourly employees, as well as all newly hired employees. As part of our commitment to comply with all relevant regulations and guidances, if you are seeking a medical or religious exemption, you may request a reasonable accommodation at any point in the selection process. Supporting medical or religious documentation will be required where applicable. You may initiate that process by completing our Accommodations for Applicants form. Flexible work from home options available for all roles at Epizyme.

Keywords: Epizyme, Inc., Cambridge , Clinical Supply Chain Manager, Professions , Cambridge, Massachusetts

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