Scientist - Molecular Biology, Cell Culture Upstream Process Development

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve.

This is hard, urgent, selfless work, but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Overview

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

Position Summary

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 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  &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.

• 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  &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.

• 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
• PhD will not be considered at this job level
• 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.
• 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…