Director​/Senior Director, Analytical Development

Director/Senior Director, Analytical Development

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 an exceptional Director/Senior Director (commensurate with experience), Analytical Development to join our Process Development and Analytical Sciences (PDAS) team to lead analytical method development activities for Orna’s oRNA‑based lipid nanoparticle therapeutics from research to clinic. The ideal candidate will have analytical development expertise with biologic, mRNA/oRNA and/or gene therapy and provide leadership in developing strong analytical portfolio for Orna pipeline candidates.

The incumbent will work closely with R&D, Process development, Manufacturing and Quality control to develop novel release and characterization methods. This role will manage the transfer of methods to contract labs or contract manufacturing organizations for GMP testing of drug substance, drug product and novel lipids. They will author relevant CMC sections and supporting documents for regulatory filings. The role will also manage all aspects of internal analytical lab to ensure reliable analytical testing is performed, including the management of methods, SOPs, protocols and method development reports.

We are looking for enthusiastic, detail‑oriented, highly motivated talent with a passion for bringing novel medicines to patients and who are comfortable working in a fast‑paced scientific team.

Key Responsibilities:

• Lead, manage and develop the analytical development team
• Responsible for the development of analytical methods that robustly test and characterize our oRNA‑based lipid nanoparticle platform products, management of testing multiple programs
• Build and develop analytical understanding to support robust clinical supply of our platform products
• Design, execute and document analytical method development in support of process development, product release, stability and product characterization of oRNA‑LNP platform products. Work cross‑functionally to develop phase‑appropriate specifications for DS, DP and novel lipids
• Maintain awareness of current industry trends and practices for design, development and optimization of analytical methodologies for testing and characterization of oRNA DS, DP, novel excipients
• Establish and manage appropriate laboratory controls for sample management, data integrity, reagents, and equipment
• Draft, review and approve method development and qualification reports
• Work with internal and external laboratories to assure robust method development, transfer, and execution in GMP and GLP settings
• Author, review and approve – IND/IMPD sections; participate in scientific advice preparations and meetings
• Lead and develop Analytical Development team members and advocate for the group through participation in internal and external forums and continuously improve the team’s performance
• Contribute to a positive and exciting work environment; contribute to a strong entrepreneurial and creative culture

Required Skills:

• Strong oral and written communication capabilities; demonstrate excellent collaboration & interpersonal skills; and be adept at problem solving in a fast‑paced environment
• 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
• 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…