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VP, Manufacturing

Reference Number: 3040
Location: MA

Our client is a rapidly growing, clinical stage biopharmaceutical company.  They have asked us to assist them in their search for a VP, Manufacturing.

The VP, Manufacturing will be accountable for the successful planning and execution of drug substance and drug product validation campaigns.  The incumbent will play a key role in writing and reviewing the CMC section for FDA and EMA regulatory filings, in collaboration with Quality and Regulatory.  The incumbent will also identify additional vendors to address future supply risk.

This person is responsible for the coordination of manufacturing activities, cross-functional meetings and communication with the senior management team.  This position assists the Senior Management Team in reaching timely, data-driven decisions with regard to CMC and drug manufacture.

Major tasks and responsibilities will include:

  • Manages current CMOs and develops a strong network of new API and drug product vendors.
  • Manages program activities, timelines, and critical issues as needed to ensure successful delivery of study objectives.
  • Performs on-site visits as needed (current suppliers are located in USA, Europe and Asia).
  • Develops and tracks a budget. Secures approval of changes arising throughout the year due to changing conditions/plans.
  • Prepares and reviews regulatory documentation towards US and EU filings.
  • Communicates with all development functions within the project team and provides regular updates on progress. Elevates issues to Senior Management Team as appropriate.
  • Coordinates effort with Early Development CMC group as needed.
  • Leads a team of 7-9 CMC scientists providing technical input in API, analytical and drug product. Hires additional staff and/or consultants as needed to accomplish project goal.

We seek candidates with the following qualifications:

  • MS or PhD in a CMC discipline, with at least 10 years drug development experience.
  • Proven expertise in process validation for both API and drug product, preferably in collaboration with external vendors.
  • Track record of successful collaboration with project managers, QA, QC and regulatory functions.
  • Experience with sterile intravenous formulations is a plus.
  • Excellent oral, written, and interpersonal skills.
  • Exhibits high degree of integrity and professionalism when interacting with consultants, external vendors and contract manufacturing organizations.
  • Strong organizational skills; ability to prioritize and multitask in order to deliver high quality work product on agreed-upon timelines and budget.
  • Experience managing external contracts and tracking budgets.

 

Do you have the skills and experience we seek and want to advance your career with one of the world’s leading companies? If so, please email your resume as a Word attachment to us, reference 3040. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.