Upstream Senior Scientist, Process Development

As an upstream Process Development Senior Scientist, you will support the development, optimization, and scale-up of mammalian upstream bioprocesses for the manufacture of biologic drug substances. You will contribute to the design and execution of laboratory experiments, data analysis, and technical documentation. Key Responsibilities Perform laboratory experiments to support mammalian upstream (cell culture) process development. Utilize Design of Experiments (DoE) for data analysis and experimental design. Assist in the optimization of upstream bioprocess parameters for yield, purity, and product quality attributes, collaborating with downstream, analytical and formulation teams. Support scale-up and technology transfer of processes to manufacturing or pilot facilities based on engineering principles including oxygen transfer. Work cross-functionally with analytical development, MSAT, manufacturing and quality teams to drive successful technology transfer. Prepare buffers, media, and other solutions according to SOPs and protocols. Operate and maintain flask and bioreactor equipment. Collect, analyze, and interpret experimental data; maintain accurate lab records and electronic notebooks. Present findings in internal and client meetings. Author technical reports and regulatory documentation. Complete Root Cause Analyses as needed, implementing corrective and preventative actions as needed. Mentor junior scientists and research associates in daily activities, data trending and data analysis. Follow all safety, quality, and compliance requirements. Qualifications Education Bachelor's, master's or PhD degree in Chemical Engineering, Biochemistry, Biotechnology, Biology, or related field. Experience 5 - 12 years of hands‑on experience in a bioprocessing or biopharmaceutical development environment (academic or industrial); some education qualifications may substitute for some years of experience. Experience in a CDMO environment is required. Experience with suspension mammalian cell culture and stirred tank bioreactors is required. Knowledge of protein purification and analytical techniques is a plus. Skills and Knowledge Understanding of cGMP, GLP, or other regulatory standards (preferred). Strong analytical and problem‑solving skills. Good written and verbal communication skills. Ability to work both independently and in a collaborative team environment. #J-18808-Ljbffr Page Mechanical Group, Inc.