Process Development Upstream Scientist

Position Summary:

As a Process Development 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. Assist in the optimization of bioprocess parameters for yield, purity, and product quality. Support scale-up and technology transfer of processes to manufacturing or pilot facilities. 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 and contribute to technical reports and regulatory documentation. Complete Root Cause Analyses as needed. 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:

4-8 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 preferred. 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.