Summary:
Our Company is a product-driven, fully integrated gene therapy firm focused on developing cutting-edge genetic therapies with life-changing or curative potential for patients suffering from life-threatening diseases such as oncology, neurology and other rare diseases. VP of Process Development will be focusing on Managing the Upstream Process team while also working cross-functionally with other PD teams.
Description:
- With upstream development, scale-up, production, and process characterization, manages and mentors a team of Scientists. Provides scientific expertise, mentoring, and development opportunities to Associates working on process development, optimization, characterization, and transfer initiatives.
- Establishes Upstream priorities and strategies, as well as guiding the development process from flatware to bioreactors.
- Through literature review and scientific teamwork, demonstrates innovative design, development, and execution of process development initiatives. Using DOE and statistical tools, designs, assesses, and interprets experimental results using a deep understanding of mammalian cell culture, scale-up, and bioreactor design, as well as the special challenges of gene therapy vector manufacturing.
- Develops techniques for the upstream production of clinical viral gene therapy material that are reliable, scalable, and transferrable. Leads the transfer of processes to CMOs and assists with regulatory filings.
- Leads from both the bench and the desk (hands-on laboratory work) (designing studies, analyzing data, preparing reports and documents).
- Study reports, process characterisation reports, transfer documents, and regulatory documents are all written by this person. Authors manuscripts and delivers findings at scientific conferences.
- Projects such as new technology development and continual improvement are led and supported by this person.
Qualifications:
- PhD in relevant scientific field; or MSc in scientific field - education in molecular biology, gene therapy and/or viral vector development and manufacture. A minimum of 15 years of experience in biologics or cell/gene therapy manufacturing in industry, with progressive proven experience in vector (AAV) manufacturing and analytical development activities for both early stage development and later stage development
- The ideal applicant will be a seasoned executive who can balance strategic and tactical needs while also knowing when a "hands on" approach is required.
- Capability to build strong relationship with internal and external stakeholders.
- The ideal candidate will be a self-starter with experience hiring, mentoring, developing, and managing subordinates to become a high-performing work group.
- Solid understanding of the FDA and GMP production regulations for cell treatments.
- Mindset that is adaptable and capable of dealing with ambiguity. Adaptability and the ability to re-prioritize workload to meet shifting deadlines.
- Personality that is independent and proactive. Dedicated to achieving the best results in the least amount of time.
