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VP of Manufacturing at ExecuNet

VP of Manufacturing

ExecuNet Waltham, MA Full-Time
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The Role:   

Company is looking for a Vice President of Manufacturing that will be responsible for GMP manufacturing of cell and gene therapy products. The Vice President Manufacturing will be responsible for leading and managing daily manufacturing activities to ensure safe and timely delivery of a portfolio of cell and gene therapy products.   The Vice President will act as the lead to build the manufacturing team and infrastructure and assist with commissioning, qualification and validation of the Base Camp Center of Innovation and GMP facility.

Here’s What You’ll Do:

  • Lead manufacturing department including policies and systems to ensure high quality GMP manufacturing
  • Lead all cross-functional GMP readiness activities for the manufacture of global cell and gene therapy products
  • Lead the development and implementation of commercial manufacturing strategy to support early and late stage GMP manufacturing
  • Develop and maintain training records, operating procedures and policies in accordance with Current Good Manufacturing Practices
  • Collaborate with process development to ensure a robust technology transfer strategy aligned with current industry best-practices (FDA guidance, ISPE standards, and others)
  • Effectively partner with Quality, Facilities and Engineering and Supply Chain to develop procedures for timely release of cell and gene therapy products
  • Establish scheduling strategy and implement tools for capacity planning in collaboration with supply chain department for effective utilization of GMP capacity
  • Apply leading-edge software solutions for optimal capacity utilization as needed
  • Work closely with Process Engineering group to ensure GMP manufacturing equipment and processing suites meet relevant GMP standards are qualified to support manufacturing campaigns 
  • Develop a GMP training program for manufacturing team
  • Prepare GMP facility for inspection by regulatory authorities in support of product approvals
  • Support regulatory group during GMP and pre-approval inspections
  • Drive continuous improvement and operational excellence culture within the department through lifecycle management and best-in-industry innovation

Requirements:

  • Bachelor’s degree in scientific/engineering discipline required (advanced degree preferred)
  • 10 years of relevant GMP manufacturing experience with 2+ years of leading a manufacturing team
  • Strong understanding of US FDA and EU EMA regulations and ICH guidelines for GMP manufacturing of cell and gene therapy products
  • Extensive experience in clean room manufacturing, aseptic processing and fill/finish is required.
  • Knowledge of cell and gene therapy manufacturing is strongly preferred
  • Knowledge of electronic systems is preferred (ERP, MES, EBR, LIMS)
  • Previous supervisory experience and demonstrated ability to lead a team effectively is required
 

Recommended skills

Engineering
Process Engineering
Laboratory Information Management Systems
Scheduling
Good Manufacturing Practices
Process Development
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Job ID: 623205

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