Associate Scientist, Upstream Process Development

Associate Scientist, Upstream Process Development

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Position Summary

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 using knowledge of cell culture, cell banking, medium preparation, bioreactor production, and primary recovery. This role is a combination of laboratory- and office-based work. This role will execute and document laboratory studies in laboratory notebooks.

Additionally, this role will support documentation review, protocols, technical reports, change controls, and CMC regulatory submissions under supervision. The Associate Scientist is expected to follow detailed GLP/GMP procedures and safety requirements and will work in a team environment and will interact with other functional departments. Additionally, this position is a team-based position that may require work on evenings, weekends, and holidays.

Duties & 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, process robustness initiatives, process troubleshooting, process 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, process characterization, as well as validation protocols with supervision
• 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
• 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
• Preparation of media, buffers, and reagents
• Analyze samples on HPLCs and other analytical instrumentation such as metabolite and cell viability analyzers, and Raman spectroscopy
• Work with other team members and on cross-functional technical teams

Education & Experience

• 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 is required.
• 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.

Knowledge, Skills, Abilities

• 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…