Sr. Scientist, Upstream Process Development, Gene Therapy
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Accentuate Staffing is recruiting a Sr. Scientist, Upstream Process Development, Gene Therapy for growing company in Durham, NC. This is a permanent opportunity!
Responsibilities:
- Assess and interpret experimental data using DOE and statistical techniques.
- Develops robust, scalable, transferable processes for upstream production of rAAV clinical gene therapy vectors.
- Serve as a Subject Matter Expert (SME) for the development of robust, high performing upstream processes with emphasis on transferability to cGMP manufacturing and supports regulatory filings.
- Leads both from the bench and from the desk (designing studies, analyzing data, preparing reports and documents).
- Training new or current team members and delegating tasks appropriately.
- Assist in the generation of project and cost proposals, timelines, and work plans by applying scientific knowledge and project management experience.
- Writes study reports, process characterization reports, transfer documents, and regulatory documents.
- Authors manuscripts and presents results at scientific meetings.
Requirements:
- MS or PhD (Chemical engineering, Bioengineering, Biology, Biochemistry, Virology, or related field) with 5+ years’ experience or MS with 8+ years’ experience, in process development of large molecule or cellular therapies.
- Knowledge and experience with media development, fed-batch, perfusion etc. methodologies.
- Knowledge and working experience with cell culture process development in mammalian cells, process scale-up, bioreactor design and optimization, and transfection.
- Knowledge and experience with process characterization and transfer is essential.
- Expertise in DOE and statistical analysis of data is essential.
- Knowledge and experience with ambr systems.
- Knowledge of viral gene therapy (AAV vectors preferred); background in protein and/or viral engineering
- Experience leading teams of scientists and associate scientists.
- Understanding and knowledge of regulatory requirements for biologic products.
- Hands on knowledge of DOE, JMP, FlowJo and GraphPad statistical software for use in design of technology development studies in a highly desirable.
- Experience in regulatory IND filing and working knowledge of US/EU CLD requirements is highly desirable.
