Advisor

About the Role

The Advisor is responsible for upstream process development activities for the production of bioproduct active pharmaceutical ingredients. This includes cell line development, cell culture process definition and optimization, process robustness studies, process transfers to pilot plant and manufacturing sites, and authorship of upstream process development sections of Regulatory submissions. The position will interact closely with other scientists in BR&D, Discovery, Technical Services for Manufacturing, and Manufacturing. The role is an integral participant on multidisciplinary CMC project teams supporting bioproduct process and product development.

Key Responsibilities

• Design, execute, and interpret upstream development experiments for the generation of bioproduct active pharmaceutical ingredients, including protein intermediates for bioconjugation.
• Provide support, including hands-on experiments, for troubleshooting technical issues and driving innovation projects with novel ideas and technologies.
• Participate in cross-functional process development teams and collaborate effectively with other groups in BR&D, Discovery, Technical Services for Manufacturing, and Manufacturing.
• Support the transfer of cell culture processes to pilot plant and manufacturing sites.
• Author technical reports and regulatory documents.
• Work effectively with external parties on development projects, research collaborations, and outsourcing efforts.
• Support organizational initiatives to achieve departmental goals.
• Engage externally through conference attendance, presentations, and publications.
• Identify, partner with, and develop process innovations from external sources to complement existing capabilities and areas of focus, and incorporate these across the portfolio.
• Ensure work is aligned with all relevant Development Quality, Regulatory, HSE, GLP, and GMP requirements.

Requirements & Tech Stack

• PhD in Microbiology, Cell Biology, Molecular Biology, Biology, Chemical Engineering, or closely related STEM discipline.
• Knowledge of cell biology, cell culture, molecular biology with an emphasis on recombinant protein expression.
• Extensive experience with designing experiments, generating data, interpreting results, and documenting work independently.
• Ability to work well in a team environment, incorporating a variety of functional relationships.
• Desire to be a point of accountability.
• Effective oral and written communication skills.
• Strong self-management, task planning, and organization.

Additional Preferences

• Postdoctoral experience.
• General knowledge and understanding of upstream process scaling, potential issues, and mitigation strategies.
• Hands-on experience with cell line generation, fed-batch and/or perfusion cell culture processes, bioreactor control strategies, and process parameter optimization.
• Demonstrated knowledge of engineering principles.
• Experience with automation and AI tools.
• Demonstrated strong problem-solving and decision-making skills.
• Ability to work productively in an interdisciplinary team environment.