Associate Director, Drug Substance Development & Manufacturing
Epizyme, Inc. is a late-stage biopharmaceutical company committed to rewriting treatment for cancer and other serious diseases through novel epigenetic medicines. Epizyme is broadly developing its lead product candidate, tazemetostat, an oral, first-in-class EZH2 inhibitor, with studies underway in both solid tumors and hematological malignancies, as a monotherapy and combination therapy in relapsed and front-line disease. The company is also exploring development candidates in its novel G9a inhibitor program. By focusing on the genetic drivers of disease, Epizyme's science seeks to match targeted 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.
Reporting to the Senior Director, Drug Substance Development & Manufacturing, the Associate Director, Drug Substance Development & Manufacturing will work closely with other CMC functions and multidisciplinary project teams to ensure delivery of high-quality drug substance to support clinical and commercial objectives.
- Works with external labs and manufacturers to develop and scale efficient processes for small molecule manufacture, providing high-quality drug substance to support clinical and commercial programs.
- Supervises activities at contract manufacturers, including plant-floor support, and manages consultants as needed to ensure effective execution of drug substance manufacturing activities and attainment of goals.
- Contributes top-tier expertise in chemical process development to identify and implement safe and scalable syntheses for starting materials, intermediates, and final drug substance.
- Develops and leads phase-appropriate drug substance project plans: prepares proposal requests, contributes to vendor selection, and manages the successful execution of plans consistent with operating budget and corporate objectives.
- Authors development reports, critically reviews batch documentation, and contributes to the preparation of the drug substance sections of regulatory documents (IND, IMPD, NDA).
- Effectively integrates drug substance activities with those of sister CMC functions, including Drug Product Development & Manufacturing, Analytical Development, Quality Assurance, and Regulatory Affairs.
- Effectively and professionally represents the drug substance function on project-level cross-functional teams, collaborating to define development strategy and meet overall program goals and timelines.
Education & Requirements
- PhD. in chemistry and 7-10 years of relevant experience in small molecule drug substance development and manufacturing.
- Direct experience with small-molecule process scale-up. Demonstrated ability to translate laboratory results into successful manufacture of drug substance on pilot and commercial scales.
- Expertise in synthetic organic chemistry and working knowledge of associated analytical techniques.
- Strong knowledge of GMP requirements for drug substance manufacture and associated analytical activities, as well as broader drug development guidelines and regulations (ICH, FDA, and EMA).
- Experience working across both early and late phases of clinical development preferred.
- Ability to lead, motivate, and engage external partners to ensure successful delivery of projects.
- Solid oral and written communication skills, with experience presenting to diverse audiences, and preparing technical reports and regulatory filings.
- Strong problem-solving skills and ability to overcome process challenges while working within project timelines.
- Periodic travel to support manufacturing operations will be required (approximately 15% of time).
- Clear alignment with Epizyme’s Core Values: Collaboration, Disciplined, Innovative, Openness, Patient-Focused, and Resilient.
Epizyme, Inc. is a vibrant, entrepreneurial EEO employer committed to a diverse and dynamic workplace.