Vice President, CMC Process Development - Gene Therapy (REMOTE)
Company: GQR Global Markets
Posted on: January 16, 2022
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
The individual will serve as a mentor and coach to CMC personnel,
modeling behaviors and leadership aligned with our company
This position can be fully REMOTE
- 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
- 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
- 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
- Ability to work in cross-functional teams effectively and
interacting with external collaborators to build strong
- Excellent organization, verbal and written communication and
Keywords: GQR Global Markets, Jacksonville , Vice President, CMC Process Development - Gene Therapy (REMOTE), Executive , Jacksonville, Florida
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