Senior Advisor, Manufacturing Science and Technology

Senior Advisor, Manufacturing Science And Technology

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, Manufacturing Science and Technology to join our team. The candidate will manage external manufacturing activities for Orna's proprietary lipid manufacturing and pipeline support to circular RNA and lipid nanoparticle candidates. Primary responsibilities include working with internal stakeholders and third-party vendors to plan external manufacturing activities. This role will also ensure timely delivery of materials and acting as the primary liaison with external suppliers, logistics providers, and test/manufacturing partners.

The ideal candidate will have extensive experience working with a variety of CDMOs for cell and gene therapy or nanoparticle applications and working with internal R&D, CMC and other teams. Furthermore, the candidate will possess strong oral and written communication capabilities, demonstrate excellent organization, collaboration, and interpersonal skills, and be adept at problem solving in a fast-paced environment.

Responsibilities:

• Primary responsibility for technical and operational management of manufacturing operations for custom raw materials (Lipids) through their development lifecycle.
• Support drug substance (DS) and drug product (DP) manufacturing for preclinical and clinical studies, enabling seamless transition to commercial supply.
• Provide guidance and direction for manufacturing strategy, goals, budgets, and other operational activities to ensure timely delivery.
• Integrate internal and external team activities into the manufacturing operations and present plans and progress to the Leadership Team as needed.
• Manage CDMOs for manufacturing operations, tech transfers, investigations/OOS, and batch documentation reviews.
• Responsible for identification and selection of CDMOs for cGMP manufacture for Orna's portfolio development programs.
• Resolve any issues impacting timelines or other critical deliverables, communicate potential impact(s) to management and other key stakeholders, and assist in mitigation plans.
• Author regulatory and technical documents for regulatory submissions in support of custom raw materials (Lipids) manufacturing and serve as subject matter expert in regulatory interactions.

Basic Requirements:

• PhD, Master's, or Bachelor's degree in chemistry, life sciences, engineering, or related field with the following years of relevant industry experience:
  PhD 6+ years, Master's 9+ years, or Bachelor's 12+ years.
• Experience with Lipid or excipient manufacturing and scale-up is required.
• A minimum of 7+ years of manufacturing operations experience in the biopharmaceutical/pharmaceutical industry covering RNA/LNP modalities.
• Good understanding of tech transfer, cGMP manufacturing and regulatory requirements for RNA and LNP modalities.
• Experience working with cross-functional product development teams, including Research & Development, QA, Pre-clinical and Safety, Regulatory Affairs, and other groups.
• Experience with authoring and reviewing early and/or late-stage…