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.