The Role:

Elevatebio is looking for a Scientist for the process development of viral vectors (AAV, LVV, etc.). This position is responsible for the upstream process development and supporting GMP manufacturing activities for viral vectors and genetically modified products. The Vector Process Development group will lead the translation of research process to cGMP compliant manufacturing using state of the art technology. The vector process development upstream scientist will be responsible for the development, scale up and technology transfer of production processes for viral vector manufacturing processes with a focus on perfusion technology (ATF, TFDF, or TFF). The Scientist is required to have experience developing viral vector manufacturing processes. The successful candidate must have successfully demonstrated technical proficiency, scientific innovation, independent thinking and cross-functional collaboration.

Here's What You’ll Do:

• Drive the development of a robust and highly productive upstream process for the manufacturing of viral vectors (primarily focused around LVV and AAV) with the use of perfusion technology (ATF/TFDF).
• Design and conduct process development studies based on with the use of statistical models for range defining and process characterization activities
• Support technology transfer and scale-up production internally and to CMO facilities with the use of process knowledge based on PD capabilities and scales
• Generate and manage data reports in an ELN system and support the verification of further datasets to ensure accuracy and QA compliance
• Represent the process development function in internal cross-functional team forums to provide insight and direction based on PD knowledge and support communication with external forums (i.e. conferences, webinars) with PD knowledge and capabilities
• Author, review, and approve protocols and reports for process development studies within the Veeva quality system

Requirements:

• Degree in a biology, engineering, or a related field with a preference of advanced degrees (MS or PhD): PhD with 1-2 year of relevant experience; or a MS with 4-5 years of industrial experience, or BS with 6+ years of industrial experience
• Biotech experience is strongly preferred including experience working in a process development/ R&D/cGMP environment
• Relevant experience working with biologics required; experience with viral vectors preferred
• Prior experience with cell culture development, including work with media and related raw material attributes
• Prior experience with stir tank and fixed bed bioreactors is required
• Prior experience with perfusion systems within bioreactor unit operations, including ATF, TFF, or TFDF operational knowledge
• Strong understanding of DoE and statistical analysis, with experience in JMP or Minitab software for design and analysis
• Capable of leading multiple projects with effective communicating and technical writing skills to support client and internal timelines