Quality Recruiting. Established Experts.

Vice President, CMC

Reference Number: 3819
Location: NY

Our client is a clinical-stage biotechnology company leveraging novel technologies to create new therapies.  They have asked us to assist them in their search for a Vice President, CMC. 

Major tasks and responsibilities will include:

  • Establishes and oversees pharmaceutical development strategy and tactical implementation plans for phase-appropriate formulation and manufacturing deliverables.
  • Enables timeline execution of product development plans and corporate goals. 
  • Serves as discipline head for CMC.  Builds the internal CMC function and leads the team on the day-to-day management of programs
  • Works with Regulatory, Quality Assurance, and senior management to develop, refine and ensure compliance with GMP and relevant regulations in US and EU.
  • Effectively manages multiple vendors.
  • Maintains knowledge of current best manufacturing practices and regulatory guidance’s and regulations.
  • Leads preparation/content development of FDA and international regulatory filings in collaboration with Regulatory and Quality and the EVP of R+D.
  • Oversees all manufacturing operations, including review and approval of master and executed batch records from all manufacturing activities; analytical release testing, stability studies and investigations, as scope of work (SOWs) with CMOs.
  • Communicates effectively, builds relationships, and actively partners with other discipline heads, CMOs, vendors, analytic laboratories, and consultants.
  • Develops and oversees scale-up and analytical testing of drug substance (API) and drug product (DP) production for preclinical safety/clinical testing and commercialization.

We seek candidates with the following qualifications:

  • PhD. or equivalent in Biochemistry, Protein Science, Chemical Engineering or related Life Science discipline required.
  • Must have a minimum of 15 years of pharmaceutical/biotech industry experience in manufacturing.
  • Requires extensive experience with the development, optimization, and scale-up of manufacturing processes.
  • Formulation development and/or therapeutic protein expertise highly preferred.
  • Requires experience authoring regulatory submissions.
  • Must have end-to-end drug development and commercialization experience, with prior experience leading the CMC discipline thorough successful BLA or NDA submissions and approvals, product launch and commercial stage manufacturing and supply chain.
  • Requires experience in managing multiple functions such as upstream/downstream process development, analytical development, formulation development, and experience in oversight and management of CMC activities at CMOs and partner facilities.
  • Must be able to set up supply chain strategy while being technically competent to collaborate internally and with outside vendors on multiple process development issues.
  • Requires strong analytical and problem solving skills, with ability to ‘troubleshoot’ in all areas of CMC.
  • Must have solid understanding of FDA and EMA regulatory guidance’s and requirements.
  • Demonstrated ability to represent the company at regulatory meetings required.
  • Must have thorough knowledge of GMP requirements, and basic familiarity with GLP/GCP.
  • Must be able and willing to travel domestically and internationally, as needed.

If interested, please email your resume as a Word attachment to us, reference 3819.  No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.

Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms.