Associate Director, CMC - Biotech - Remote

Company: Meet
Location: Cambridge
Posted on: February 23, 2021

Job Description:

Job Title:Associate Director, CMC - Biotech - Remote
Summary:Meet Recruitment is working with a clinical stage biotechnology company, developing a new class of immunomodulatory and gene regulating drugs against validated targets, to find an Associate Director, CMC. The Associate Director, CMC, will be responsible for overseeing the GMP manufacturing of oligonucleotide conjugates and SNA nanoparticles at contract manufacturing organizations (CMOs).

Job Responsibilities:

• Develop and implement strategy for the manufacture of oligonucleotides and SNA from the time of GLP tox through approval
• Manage drug substance and drug product manufacture at CMOs and ensure uninterrupted supply of multiple drug products for clinical trials
• Manage manufacturing operations, including technology transfer, process development, analytical development, scheduling, logistics, batch record review, change controls, review of validation protocols, development of specifications and execution of appropriate ICH stability studies
  Skills Required:
  • PhD, MS, or BS in chemistry or related field with relevant expertise in GMP manufacturing of small molecules or oligonucleotides
  • Understanding quality and regulatory requirements in the pharmaceutical industry pertaining to ICH, GMPs and USP guidance and standards
  • Demonstrated ability to create and implement both short-term and long-term plans to support CMC goals
    Please contact if you would like to know more about this opportunity.

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