Process Development Upstream Scientist

Job Description

Job Description

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.