Job Description

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• Perform plasmid cloning, transformation, amplification, and purification.

• Maintain mammalian cell cultures using aseptic techniques.

• Set-up and operate benchtop and large-scale single use bioreactors (50 to 100L)

• Utilize DoE methodology to optimize cell growth and viral vector titers in suspension mammalian cell cultures.

• Serve as Subject Matter Expert for cell culture and bioreactor operations and data interpretation.

• Collaborate with team members to identify and evaluate process improvements with the goal of optimizing the current rAAV production process.

• Perform molecular biology and analytical assays to support the upstream and downstream PD efforts.

• Draft and edit lab protocols, standard operating procedures, sampling plans, technical documents, and batch records for regulatory or tech transfer purposes.

• Search literature for methods, processes, and assess new equipment and technologies in order to expand and improve upstream AAV capabilities.

• Provide hands-on technical guidance and training to the team to perform process understanding of experiments and characterization studies.

• Routinely mentor junior scientists on scientific background and technical aspects of work.

• PhD in Cell and Molecular Biology, Biomedical engineering, Biochemistry, Biotechnology, Chemical Engineering or related fields with ~8 years or more relevant experience, or Master/Bachelor’s degree with ~10 years or more relevant industry experience.

• Considerable direct experience with mammalian cell expression technology and media optimization, utilizing suspension-based bioreactor systems is required.

• Prior experience in viral vector GMP manufacturing, process characterization and QA/QC release testing of viral vector products are required.

• Experience working in a BSL-2 environment and using aseptic techniques.

• Hands-on experience with bench-scale bioreactor operations and large-scale single use bioreactors (50 to 100L) are required.

• Proficient in general molecular biology techniques such as SDS-PAGE, Western blot, flow cytometry, ELISA, ddPCR, qPCR, PCR and cell-based potency assays.

• Experience in drafting study plans, technical reports, and protocols.

• A highly motivated team player with an ability to be productive and a willingness to lead and learn in a fluid, fast-paced and environment are essential.

• Excellent organizational and collaborative skills, with the ability to design and troubleshoot experiments with minimal supervision or as part of a group.