Job Description

: . 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.Requirements: . 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.
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