Associate Director/Director, Drug Substance Development & Manufacturing

Company: Amazon Workforce Staffing
Location: Cambridge
Posted on: September 17, 2020

Job Description:

Associate Director/Director, Drug Substance Development & Manufacturing Company: Epizyme

Location: Cambridge

Posted on: September 12, 2020

Job Description:

Epizyme, Inc. is a fully integrated commercial-stagebiopharmaceutical company committed to its mission of rewritingtreatment for cancer and other serious diseases through novelepigenetic medicines. In addition to an active research anddiscovery pipeline, Epizyme received U.S. FDA approval for theproduct, TAZVERIK™ (tazemetostat), for the treatment of patientsaged 16 years and older with metastatic or locally advancedepithelioid sarcoma who are not eligible for complete resection.This indication was approved under accelerated approval based onoverall response rate and duration of response. TAZVERIK™ alsorecently received accelerated approval by the U.S. Food and DrugAdministration (FDA) for the following two distinct follicularlymphoma (FL) indications: 1) adult patients with relapsed orrefractory FL whose tumors are positive for an EZH2 mutation asdetected by an FDA-approved test and who have received at least twoprior systemic therapies, and 2) adult patients with relapsed orrefractory FL who have no satisfactory alternative treatmentoptions. Continued approval for these indications is contingentupon verification and description of clinical benefit in an ongoingconfirmatory trials. The company is also exploring the treatmentpotential of tazemetostat in investigational clinical trials inother solid tumors and hematological malignancies, as a monotherapyand combination therapy in both relapsed and front-line diseasesettings. By focusing on the genetic drivers of disease, Epizymeseeks to match medicines with the patients who need them. For moreinformation, visit www.epizyme.com. Epizyme has assembled aworld-class team with a passion for scientific innovation and acommitment to developing novel epigenetic therapies. Join adynamic, diverse and fun work environment consistent with Epizyme’scultural attributes for success: camaraderie, collaboration,disciplined, innovative, openness, patient-focused and resilient.Key Responsibilities: Responsible for devising and executingstrategy for drug substance route development, processoptimization, scale-up, and validation. When necessary will overseetechnology transfer, and clinical/commercial manufacturing tosupport fast-pace clinical development programs and commercialsupply. Develop phase-appropriate pharmaceutical project plans,participate in CDMO technical selection, and manage successfulexecution of these plans consistent with corporate timelines andcompliant with cGMP/regulatory requirements and expectations.Develop and review manufacturing batch records. Write and reviewprotocols, reports, and drug substance sections for regulatorydocuments. Interface and coordinate activities with drug product,analytical development, and clinical/commercial supply teams.Collaborate with legal and procurement to review contract terms andexecution of agreements. Keep up with the latest process chemistryand regulatory literature and guidance. Education & Requirements:MS or Ph.D. in synthetic organic chemistry or closely relateddisciplines. Minimum 8 years of experience (less experience will beconsidered with advanced degree in a relevant field) withinpharmaceutical CMC development. Proven track record in processdevelopment and optimization in the early to late stage clinicalsetting. Experience with material science is a plus. Thoroughunderstanding of the application of reaction mechanism theory andkinetics in API route development and optimization. Thoroughunderstanding of the application of analytical tools andstatistical software in the development of API processes, i.e.ReactIR, standard NMR experiments, Jump software for DOE, etc.Thorough understanding of the implementation of phase appropriateIPCS in the process development, scale-up, optimization andmanufacture of API The candidate should have an appreciation ofcGMPs and regulatory requirements, along with demonstrated successin project management. Excellent verbal and written communicationskills. Ability to work with minimal supervision and to setpriorities to meet timelines. Strong interpersonal communicationskills, proven ability to build and maintain collaborative,effective internal and external relationships. Ability to travel tomanufacturing and other partner sites (approximately 10-30 % oftime, once COVID travel restrictions are removed). Epizyme, Inc. isa vibrant, entrepreneurial EEO employer committed to a diverse anddynamic workplace.

Keywords: Epizyme, Cambridge , Associate Director/Director, Drug Substance Development & Manufacturing, Other , Cambridge, Massachusetts

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Keywords: Amazon Workforce Staffing, Cambridge , Associate Director/Director, Drug Substance Development & Manufacturing, Other , Cambridge, Massachusetts