Senior Director, CMC (Biologics)

  • Cambridge, MA
  • Posted 23 days ago | Updated 6 hours ago

Overview

On Site
Full Time

Job Details

Job#: 2030201

Job Description:
Senior Director, CMC (Biologics) 2030201
Location: Cambridge, MA (Onsite)
Science: Biologics/ Protein Therapeutics
Job Overview: Lead and oversee the development, optimization and tech transfer of Biological CMC manufacturing efforts between internal teams and external CDMO's for early stage clinical development.
Primary Job Responsibilities:
  • CDMO management and oversight
  • Tech transfer of methods and processes to CDMO for early stage clinical manufacturing
  • Prepare and oversee IND enabling including regulatory CMC sections
Primary Job Requirements:
  • Seasoned leader who possesses a PhD with 10 or more years in industry with strong experince in biologic CMC and process development
  • Extensive experience overseeing CDMO's for tech transfer of protein manufacturing including both upstream and downstream
  • Exposure to managing analytical studies for IND
  • Travel to CDMOs
About Stratacuity:
Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.
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