QC Manager/Team Lead (Woburn, MA)

August 20, 2021

Location: Woburn, MA, USA

Position Summary:

The US QC Manager/Team Lead will be a motivated, pro-active employee, dedicated to leading all QC activities in a GMP environment.  This experienced QC expert will be expected to be very hands-on.  The individual must learn all qualified QC methods for assessing Minovia’s drug substance and drug product, to enable a smooth and timely technology transfer to a new manufacturing facility in the US, to lead and perform qualification of all QC methods, and to support regulatory filings to enable Ph I/II clinical trials in an exciting mitochondrial cell therapy space.

Responsibilities:

  • Managing routine analytical testing of dug substance and drug product and corresponding stability
  • Managing one or more QC analysts in the US site, including hands-on testing training, and maintaining qualified QC employees
  • Future implementation of raw material testing program
  • Oversight of routine environmental monitoring for the GMP production suite
  • Management of out-sourced QC testing labs
  • Managing the QC lab, including ensuring equipment follows and complies with the Site Calibration plan
  • Managing QC-related Deviations, CAPA’s and change controls
  • Writing of QC documents, including protocols, reports, SOPs, test methods and forms, including providing QC reports and results required for regulatory filings
  • Trending and issuance of annual reports

Requirements:

  • BS or advanced degree in biology, chemistry, life science or related disciplines
  • 3-5 years’ QC experience, with relevant experience as a QC team leader/manager from a pharmaceutical/ biotech company
  • Experience operating in a GMP environment
  • Experience in flow cytometry, microbiology, mammalian cell culture
  • Experience in Biochemistry and molecular/microbiology methods

Skills:

  • Teamwork – Ability to work well in a highly cross-functional team environment
  • Communication – Able to communicate clearly and concisely within team; timely and effectively communicates issues to supervisor
  • Analytical and Problem-Solving Skills – Able to troubleshoot critical issues or problems and determine causes and possible solutions using appropriate information
  • Organization – Exercises good time management and prioritization skills and can successfully manage multiple tasks simultaneously
  • Motivated – Self-motivated and willing to accept temporary responsibilities outside of initial job description, understanding that priorities may change quickly in our dynamic, patient-centric business
  • Willingness to travel – 10%

To apply, contact Bethany Sensenig, CFO and Head of US Operations – bethany@minoviatx.com

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