Associate Scientist, Upstream Process Development

About the Role

The primary role of the Associate Scientist, Upstream Process Development is to execute laboratory experiments in the development, optimization, characterization, and scale-up of biologics upstream cell culture processes from laboratory to manufacturing scale. This position combines laboratory- and office-based work and involves documenting laboratory studies, supporting documentation review, protocols, technical reports, change controls, and CMC regulatory submissions under supervision. The role requires adherence to detailed GLP/GMP procedures and safety requirements, teamwork, and occasional work on evenings, weekends, and holidays.

Responsibilities

• Leverage an understanding of the drug substance upstream cell culture process to support execution and data analysis of scale-down/scale-up studies for media development and optimization, upstream process development, process characterization, and process validation.
• Support development of the upstream inoculum expansion and cell culture process control strategy through identification of critical process parameters and process attributes.
• Support process technical transfers from laboratory-scale or pilot-scale to manufacturing-scale.
• Support process optimization, robustness initiatives, troubleshooting, yield improvements, and process-related investigations at manufacturing-scale through conducting scale-down studies.
• Document execution and results of experimental plans in laboratory notebooks, perform data verification, and author and review SOPs and upstream cell culture documentation to capture experimental designs and results via protocols and other associated scientific technical documents for process development, characterization, and validation.
• Support continuous process improvements and advance technology for implementation in laboratory and manufacturing operations.
• Support CMC review and verification of regulatory filings (IND, IND amendment, BLA, MAA, PAS, etc.), with interactions with global Health Authorities for inspections.
• Perform cell culture expansion and handling utilizing sterile technique in plates, T-flasks, and shaker flasks.
• Support routine operation, cleaning, and maintenance of laboratory equipment, including small-scale and pilot-scale bioreactors, autoclaves, centrifuges, scales, and balances.
• Prepare media, buffers, and reagents.
• Analyze samples on HPLCs and other analytical instrumentation such as metabolite and cell viability analyzers, and Raman spectroscopy.
• Collaborate with other team members and cross-functional technical teams.

Requirements

• Bachelor's degree in Biology, Chemistry, Biochemical Engineering, Chemical Engineering, or a related scientific field, or equivalent combination of education and relevant industry experience.
• Relevant experience in biologics upstream process development, manufacturing, and/or manufacturing technology.
• Candidates should possess:
  • A B.Sc. or B.Eng. with 3-5 years of relevant experience, or
  • An M.Sc. or M.Eng. with 0-2 years of relevant experience.
• Experience with mammalian cell culture processes, aseptic technique, and bioreactor operations is preferred.
• Experience working in a GLP/GMP-regulated environment and supporting technical documentation is preferred.
• Experience with experimental design, statistical analysis, and process development data interpretation is preferred.

Skills

• General scientific knowledge and laboratory skills; knowledge of upstream mammalian cell culture and bioreactors is preferred.
• Experience with experimental design, statistical design, and data analysis is preferred.
• Strong problem-solving skills, with the ability to apply risk-based critical thinking in a technical environment.
• Effective written and verbal communication skills, including the ability to prepare and present scientific and technical information.
• Ability to complete assignments accurately, compliantly, and within established timelines.
• Ability to work effectively both independently and as part of a cross-functional team.
• Strong attention to detail and commitment to quality and safety standards.

Physical Demands

• Frequent repetitive motions may be required, including pipetting, lifting, bending, twisting, squatting, crouching, kneeling, reaching, and climbing step stools.
• Occasional unassisted lifting of up to 50 pounds may be required.
• Repetitive use of the arms, hands, and wrists, including grasping and fine motor movements, is required.
• Office-based responsibilities associated with the role may require extended periods of sitting and computer use.

Work Environment

• This position is primarily laboratory-based and performed in an indoor environment.
• Appropriate personal protective equipment (PPE) must be worn when working in laboratory areas.
• The role may involve exposure to biohazardous materials, including live cell cultures, as well as hazardous chemicals such as methotrexate, acids, and caustics. Handling of powdered materials and high-temperature liquids or solids may also be required.
• The position requires working both collaboratively with cross-functional teams and independently.
• Occasional shift work, including evenings, weekends, and holidays, may be required to support project and operational needs.
• This role is performed in a dynamic, fast-paced, collaborative, and innovative environment.

Less than 5% travel required for this role.

Pay

Pay Range: $60,000 USD - $88,000 USD

Benefits

Target Bonus: 8%