Associate Director, CMC Technical Project Manager (CONTRACT)

Orna Therapeutics 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’re looking for a motivated and proactive CMC Technical Project Manager, driving execution of complex CMC activities across internal and external manufacturing operations. In this role, you'll collaborate with scientific and operational leaders to shape and deliver program strategies that advance our mission to bring forward novel medicines for patients with unmet needs. The candidate will lead CMC Technical Project Management activities for Orna’s 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.

Key Responsibilities: 

• Technical Project Management of manufacturing operations for custom raw materials (Lipids and Plasmid), Drug substance (DS), Drug product intermediate (DPI) and Drug product (DP) supporting pre-clinical and clinical studies and eventual transition to commercial supply.
• Lead CMC program sub team meetings for multiple complex scientific programs and collaboratively drive the execution of program strategies to achieve both program and corporate milestones.
• Oversee the organizational and contractual aspects of vendor management.
• Develop and guide CMC program strategy and facilitate team decision making for the program, working in partnership with the Research Leadership Team.
• Work with the Program/Team Lead, to develop and maintain detailed CMC program Risks, milestones and timelines.
• Integrate internal and external team activities into the manufacturing operations and present plans and progress to the Leadership Team as needed.
• Manage timelines for manufacturing operations, tech transfers, investigations/OOS, and batch documentation reviews.

Required Skills: 

• Be familiar and close enough to details of the science, programs, and day-to-day activities to be able to anticipate any potential program risks and issues. 
• Project management best practices including timelines, development of meeting agendas, streamlined and efficient meeting management, and distribution of meeting minutes and efficient follow up of action items. 
• Strong leadership skills, including demonstrated ability to work with a cross-functional team, and to influence at all levels of an organization.
• Develop effective and efficient working relationships with both internal and external partners. Available to travel if/when needed.
• Strong analytical and problem-solving skills are necessary along with great attention to detail.
• Excellent oral and written communication skills, including presentation to effectively communicate key updates/challenges to the program team.
• Detail oriented, self-motivated, and excited to take on new challenges!

Qualifications: 

• Bachelor's degree in life sciences, engineering, or related field. Advanced degree in life science (MS or PhD) preferred.
• Project management experience with Cell and Gene therapy manufacturing and scale-up is required.
• Project management experience in the biopharmaceutical/pharmaceutical industry covering RNA/LNP modalities is preferred.
• 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 managing early and/or late-stage regulatory filings is preferred.
• Project management