Principal Scientist/Sr. Principal Scientist Molecular Biology, Cell Culture Upstream Process Development

Role Summary

Principal Scientist/Sr. Principal Scientist Molecular Biology, Cell Culture Upstream Process Development. Responsible for upstream process development activities related to the production of bioproduct active pharmaceutical ingredients including 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. Expected to collaborate with BR&D, Discovery, Technical services for Manufacturing and Manufacturing teams and participate on multidisciplinary CMC project teams.

Responsibilities

• Design and execute appropriate upstream development experiments for generation of bioproduct active pharmaceutical ingredient including protein intermediates for bioconjugation.
• Provide hands-on support for troubleshooting technical issues and driving innovation projects with novel ideas and technologies.
• Participate in cross-functional process development teams and collaborate with BR&D, Discovery, Technical services for Manufacturing and Manufacturing.
• Support transfer of upstream 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 short-term and long-term departmental goals.
• Stay current with relevant scientific literature, new technologies/capabilities and regulatory initiatives/requirements and support their implementation as appropriate.
• Ensure work is aligned with Development Quality, Regulatory, HSE, GLP and GMP requirements.

Qualifications

• BS/MS in Microbiology, Cell Biology, Molecular Biology, Biology, Chemical Engineer, or related field
• BS with >6 or MS with >3 years of relevant industrial experience
• Ability to work well in a team environment with diverse functional relationships and accountability
• Effective oral and written communication skills, self-management, task planning and organization

Skills

• Experience designing experiments, generating data, interpreting results, and documenting work independently
• Knowledge of cell biology, cell culture, molecular biology with emphasis on recombinant protein expression
• Hands-on experience with cell line generation and cell culture bioreactor operation
• Understanding of scaling upstream processes and use of statistics for data analysis
• Problem-solving with minimal supervision and ability to work in an interdisciplinary team
• Location: Lilly Technology Center North

Education

• BS/MS in relevant field as listed in Qualifications

Additional Requirements

• Location for this position will be Lilly Technology Center North