Associate Director/Director, Drug Product Development & Manufacturing

Epizyme Cambridge , MA 02138

Posted 2 months ago

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.

Key Responsibilities:

  • Manage and oversee outsourced formulation development, process development, scale-up, validation, technology transfer, and clinical/commercial manufacturing to support fast-pace clinical development programs and commercial supply.

  • Develop phase-appropriate pharmaceutical project plans, participate in CDMO selection, and manage successful execution of these plans consistent with corporate timelines and compliant with cGMP/regulatory requirements and expectations.

  • Develop and review manufacturing batch records.

  • Write and review protocols, reports, and drug product sections for regulatory documents.

  • Contribute to product investigations and conduct root cause analysis

  • Interface and coordinate activities with drug substance, analytical development, regulatory affairs, quality assurance, and clinical/commercial supply teams.

  • Collaborate with legal and procurement to review contract terms and execution of agreements.

  • Keep up with the latest regulatory and cGMP guidance.

  • Maintain awareness of state-of-the-art manufacturing practices, monitor status of CMO capacity, and provide updates to the Epizyme team.

Education & Requirements:

  • B.S. or B.A. in pharmaceutics, chemistry, chemical engineering or related discipline. Advanced degree preferred.

  • Minimum 10 years' experience (less experience will be considered with advanced degree in a relevant field) within pharmaceutical CMC development.

  • Strong understanding of oral solid dosage forms is required. Pediatric formulation experience is a plus.

  • Experience with drug product process development, scale-up, and optimization.

  • Experience with process validation and continuous process improvement a plus.

  • A solid appreciation of cGMPs and regulatory requirements, along with demonstrated success in project management is essential.

  • Excellent verbal and written communication skills.

  • Ability to work with minimal supervision and to set priorities to meet timelines.

  • Strong interpersonal communication skills, proven ability to build and maintain collaborative, effective internal and external relationships.

  • Ability to travel to manufacturing and other partner sites (approximately 10-30 % of time).

Epizyme, Inc. is a vibrant, entrepreneurial EEO employer committed to a diverse and dynamic workplace.


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Associate Director/Director, Drug Product Development & Manufacturing

Epizyme