Senior Advisor, Drug Substance Process Development

Lilly • Watertown, MA

5d • $141,000 - $228,800 • Onsite

About The Position

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.
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.
Position Summary:
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.

Requirements

• 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

Nice To Haves

• 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!

Responsibilities

• 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

Benefits

• company bonus (depending, in part, on company and individual performance)
• company-sponsored 401(k)
• pension
• vacation benefits
• medical, dental, vision and prescription drug benefits
• flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
• life insurance and death benefits
• certain time off and leave of absence benefits
• well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

What This Job Offers

• Job Type: Full-time
• Career Level: Senior