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Sr. Director Of Cmc

Company

EPM Scientific
Address Greater Boston, United States
Employment type FULL_TIME
Salary
Category Staffing and Recruiting,Biotechnology Research,Pharmaceutical Manufacturing
Expires 2023-10-13
Posted at 7 months ago
Job Description

Sr. Director of CMC - Biologics

Greater Boston Area

Competitive Compensation + excellent bonus/benefits


Duties and Responsibilities:

  • Author, review and strategically impact CMC sections (Pre-IND, IND, BLA, & MAA submissions)
  • Overlook Analytical, Formulation, & Process Development Teams for their whole R&D Portfolio
  • Will work and manage in-house and outsourced lab activities
  • Focus on multiple compounds within their pipeline (Early Stage & Late-Stage Development)
  • Provide strategic oversight - while collaborating with external partners
  • Lead and overlook the Biologics (different modalities)


Qualifications:

  • Experience working amongst CMC leaders such as Regulatory, Analytical, and Quality
  • Past Management Experience is a MUST
  • Experience overseeing outsourced vendors (CMOs/CDMOs)
  • Experience overlooking multiple drug candidates within the company's pipelines
  • M.S. or Ph.D. in Pharmaceutical Sciences or a related scientific field with ideally 10-15 years of industry experience