Job Description

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• Develop scalable and robust downstream purification processes for cell harvesting and viral vector clarification, column chromatography, TFF (hollow fiber and cassettes) for high yield and high purity viral vectors.

• Design and execute experiments for downstream process development and characterization; apply DoE-based approaches where appropriate, in order to improve robustness and understanding of operating and performance parameters.

• Set-up and operate large scale chromatography purification equipment and TFF systems.

• Serve as Subject Matter Expert for downstream 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 downstream 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 Biomedical engineering, Biotechnology, Biochemistry, 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.

• Direct experience with chromatography purification, operation, method development, and scale-up, with different resins - affinity, SEC, IEC, HIC are required.

• High level of experience with pilot-scale AKTA systems and Unicorn software is required.

• Direct experience with developing pilot-scale filtration-based processes is required (e.g. depth filtration, tangential flow filtration, microfiltration, ultra/diafiltration).

• Proficient in development of analytical techniques for characterization and analysis of purity for viral vector, including: ELISA, qPCR, ddPCR, electrophoresis (SDS-PAGE, Western blot, CE) and light scattering.

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

• 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.