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Tunnell Consulting is seeking an Upstream Process Development Scientist II/III to join our team in Boston, MA. This position is integral to the development of processes in Process Development, specifically focusing on creating a scalable platform for viral vector production. The successful candidate will be responsible for reducing risks during the transition to GMP scale-up, providing technical expertise and leadership in science and technology, and collaborating closely with internal teams. This role requires a strong foundation in biochemical engineering, virology, and cell biology fundamentals, as well as experience in the pharmaceutical industry, particularly in cGMP manufacturing and process development. The Upstream Process Development Scientist will establish lentiviral and retroviral vector processes from small to intermediate scale (up to 50L). Responsibilities include monitoring process performance, reporting findings, identifying areas for improvement in process, safety, and product quality, and optimizing processes to enhance robustness, reduce costs, and improve viral yield and purity. The individual will independently design and conduct experiments, maintain open communication through individual and team meetings, and keep up with relevant technologies while exploring new approaches. Additionally, the role involves leading the design and implementation of single-use systems for upstream bioreactors and downstream operations, developing standard operating procedures (SOPs) and standard safety procedures (SSPs) for upstream processes, and managing process transfers between clients and in-house manufacturing. The scientist will also collaborate with external suppliers for equipment and materials and act as a subject matter expert (SME) during regulatory and client audits. Ensuring a safe working environment and compliance with OSHA, EHS, Quality, and cGMP policies is paramount, as the individual will be required to work in a BSL 2 environment with personal protective equipment/aseptic gowning.
