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.
