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

Role Summary

Lead upstream process development for bioproduct active pharmaceutical ingredients, including cell line development, cell culture process definition and optimization, process robustness studies, and transfers to pilot and manufacturing sites. Prepare upstream process development content for regulatory submissions. Collaborate across BR&D, Discovery, Technical Services for Manufacturing, and Manufacturing, and participate on multidisciplinary CMC project teams to advance bioproduct process and product development.

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 effectively collaborate with other groups in 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 as needed to achieve short-term and long-term departmental goals.
• Keep current of relevant scientific literature, new technologies/capabilities and regulatory initiatives/requirements and support their implementation, as appropriate.
• Ensure work is aligned with all relevant Development Quality, Regulatory, HSE, GLP and GMP requirements.

Qualifications

• Required: BS/MS in Microbiology, Cell Biology, Molecular Biology, Biology, Chemical Engineer, or related field
• Required: BS with >6 or MS with >3 years of relevant industrial experience
• Required: Ability to work well in a team environment incorporating a variety of functional relationships and desire to be a point of accountability.
• Required: Effective oral and written communication skills, self-management, task planning and organization.
• Required: Authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.
• Preferred: Experience with designing experiments, generating data, interpreting results, and documenting the work, independently.
• Preferred: Knowledge of cell biology, cell culture, molecular biology with an emphasis on recombinant protein expression
• Preferred: Hands-on experience with cell line generation, cell culture bioreactor operation skills
• Preferred: General knowledge and understanding of issues associated with scaling of upstream processes, and use of statistics for data analysis
• Preferred: Capable of solving problems with minimal supervision
• Preferred: Work productively in an interdisciplinary team environment.