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

Principal Scientist/Sr. Principal Scientist

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.

The Bioproduct Research and Development (BR&D) organization strives to deliver innovative medicines to patients through the development and commercialization of monoclonal antibodies, novel therapeutic proteins, peptides, bioconjugates, cell therapies, gene therapies, and other genetic medicines etc. This organization is a multidisciplinary group that works collaboratively with our discovery, manufacturing and quality, business units.

The Principal Scientist/Sr. Principal Scientist is 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. The position will interact closely with other scientists in BR&D as well as Discovery, Technical services for Manufacturing, and Manufacturing scientists. They are expected to be an integral participant on multidisciplinary CMC project teams that support bioproduct process and product development activities.

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.

Basic Requirements:

• 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 incorporating a variety of functional relationships and desire to be a point of accountability.
• Effective oral and written communication skills, self-management, task planning and organization.
• Qualified applicants must be 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.

Additional Skills and Preferences:

• Experience with designing experiments, generating data, interpreting results, and documenting the work, independently.
• Knowledge of cell biology, cell culture, molecular biology with an emphasis on recombinant protein expression
• Hands-on experience with cell line generation, cell culture bioreactor operation skills
• General knowledge and understanding of issues associated with scaling of upstream processes, and use of statistics for data analysis
• Capable of solving problems with minimal supervision
• Work productively in an interdisciplinary team environment.

Physical Demands/Travel:

The physical demands of this job are consistent with a lab environment.

Work Environment:

This position's work environment is in a laboratory environment.