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Vice President, CMC Process Development - Gene Therapy (REMOTE)

Company: GQR Global Markets
Location: Jacksonville
Posted on: January 16, 2022

Job Description:

Position Overview:
We seek a highly motivated candidate to lead a small and growing group of process development scientists/engineers within our CMC Department. The ideal candidate will have demonstrated expertise in Cell & Gene Therapy process development to define strategies and oversee development, transfer, characterization and validation activities in support of the commercialization of the company's products. This includes processes for the manufacture of plasmids, viral vectors (AAV and lentivirus) and stem cell products.
The successful candidate will also be required to author and/or review regulatory documents for submissions and provide technical input to regulatory discussions. This role will also involve extensive interaction with contract manufacturing organizations, technical transfer teams and collaboration within cross-functional project teams.
The individual will serve as a mentor and coach to CMC personnel, modeling behaviors and leadership aligned with our company values.
This position can be fully REMOTE
Responsibilities:

  • Serve as a process SME from CMC in cross-functional teams. Provide necessary technical support to process development team supporting cell product, viral vectors, and plasmids.
  • Ensure technical decisions on process development are made with through review and discussion of data.
  • Support Head of CMC in providing leadership to the CMC team and maintaining an environment where staff thrive.
  • Author and/or review process description, process control, and process development sections of regulatory filings. Assist in cross-fucntional review of other regulatory submissions as required.
  • Interact with other CMC teams members, Quality, Clinical Operations, Regulatory and other personnel as dictated by project needs. Contribute in a team-oriented environment to achieve common project goals
  • Provide guidance on the development of business processes and associated SOPs for risk-based approaches for raw material risks, impurity/residual clearance, process control strategy.
  • Review and approve process development/transfer/validation study protocols and reports to ensure high quality documentation to support BLA and MAA filings and commercial readiness.
  • Maintain knowledge of scientific literature related to stem cell products, plasmids and viral vectors and identify key areas for new technology evaluation.
    Qualifications and Skills:
    • Ph.D. in Biochemical Engineering or related discipline with 10+ yrs. process development experience, or MS with 12+ yrs., or BS with 15+ yrs. Process development experience for Cell and Gene therapies is required.
    • Strong grasp and application of engineering fundamentals pertaining to process development
    • Experience with process development, tech transfer, and process validation activities
    • Ability to work in cross-functional teams effectively and interacting with external collaborators to build strong relationship.
    • Excellent organization, verbal and written communication and presentation skills.

Keywords: GQR Global Markets, Jacksonville , Vice President, CMC Process Development - Gene Therapy (REMOTE), Executive , Jacksonville, Florida

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