Senior Advisor, Drug Substance Process Development

Senior Advisor

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.

Orna Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company, is an innovative biotechnology startup based in Watertown, MA, committed to developing groundbreaking therapies for diseases that current approaches cannot address. With our pioneering circular RNA technology, developed at MIT, we are at the forefront of advancing the next generation of RNA therapeutics. Our state-of-the-art expression and delivery platform positions us to tackle complex diseases, including B cell-driven autoimmune disorders, B cell malignancies, sickle cell disease, and beyond.

We are seeking an exceptional Senior Advisor to join our team. The candidate will design, execute, and oversee experiments for technical development and scale-up of drug substance processes. The ideal candidate will have a strong background in downstream process development, process optimization, scale-up, and technical transfer. Furthermore, they will possess strong oral and written communication capabilities, demonstrate excellent collaboration and interpersonal skills, and be adept at problem solving in a fast-paced environment.

• Lead process development activities for circular RNA manufacturing supporting pre-clinical and clinical studies
• Identify critical process parameters and evaluate scale-up strategies
• Design and perform process development experiments using scientifically sound methodology, including design-of-experiments approaches
• Work with supply chain, quality, and CMC functions to manufacture of test article(s) and clinical trial material for preclinical studies
• Generate, interpret, and present data to cross-functional R&D teams
• Contribute to a positive and exciting work environment; contribute to a strong entrepreneurial and creative culture
• Collaborate with SMEs from external vendors to ensure oRNA process transfer and development efforts are aligned with program timelines and objectives
• Contribute to authoring regulatory documentation and provide input to regulatory interactions

• PhD, MS, or BS degree in chemical engineering, biomedical engineering, chemistry, biology or related field with the following years of relevant industry experience:
  PhD 6+ years, MS 9+ years, or BS 12+ years
• Experience developing biotechnology manufacturing processes, with experience in downstream biomanufacturing technologies.
• Experience working in a matrixed CMC environment (supply chain, analytical development, and formulation development)
• Experience in authoring/reviewing development sections for regulatory submissions. Strong knowledge of regulatory requirements

• Organized, collaborative, and able to work with a diverse group of scientists and engineers
• Demonstrated ability to work on cross-functional teams in a fast-paced, dynamic environment
• Detail oriented, self-motivated, and excited to take on new challenges!

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

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

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form for further assistance.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $141,000 - $228,800.