Associate Scientist/Senior Associate Scientist, Pharmaceutical Development CMC (CONTRACT ROLE)

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 are seeking an Contract Associate Scientist/Senior Associate Scientist, Pharmaceutical Sciences CMC to join our CMC team to lead pharmaceutical sciences in Pharmaceutical Development Department for ORNA lead pipeline candidates. The ideal candidate will have drug development knowledge expertise with biologic, mRNA and/or gene therapy and provide leadership in developing pharmaceutical sciences portfolio for ORNA therapeutics. They will possess strong oral and written communication capabilities; demonstrate excellent collaboration & interpersonal skills; and be proficient at problem solving in a fast-paced environment.

Responsibilities

• Lead the pharmaceutical sciences development strategy internally and at CRO’s, execute projects planning, and assure timelines and high quality of deliverables for CMC programs.
• Review and approve CRO’s relevant procedures, protocols and reports, raw data, generate internal protocols and reports, present data for CMC management review.
• Manage CRO’s workflow and timelines to align with the CMC timelines. Support projects by generating/reviewing meeting agendas and minutes. Act as project manager for relevant projects.
• Provide scientific leadership within and across functional areas that coordinate pharmaceutical sciences activities and develop strategy to support product development.
• Design, review and execute studies and report results to CMC management. Provide recommendations on relevant issues and topics.
• Develop templates and other tools to continuously improve information interpretation and summaries from original raw data sources.
• Support Pharmaceutical Development department and other CMC departments, if requested.
  
  

Qualifications

• BS (or equivalent degree) in chemistry, biochemistry, or relevant scientific discipline with 9 (MS with 5 ) years of experience in the biopharmaceutical industry.
• Knowledge of cGMP, understanding of analytical regulatory expectations.
• Understanding of analytical techniques, knowledge of analytical methodologies such as HPLC, LC-MS, DLS, CE, Spectrophotometry, and others for characterization of RNA and LNP.
• Knowledge of CMC and regulatory requirements for biologics, including ICH Quality Guidelines and appropriate cGMP authority guidelines and regulations.
• Experience with regulatory submission is preferred but not required.
• Experience with LNP, mRNA is highly desirable.
• Strong oral and technical writing skills.
• Excellent organizational, program management, and planning skills and ability to work well in a team.
  
  

Why Orna? At Orna Therapeutics, we’re more than just a workplace—we’re a community. We believe in fostering an environment where individuals can grow, thrive, and make a lasting impact on the future of healthcare. Join us as we revolutionize RNA therapeutics and make a difference in the lives of patients around the world.

Equal Employment Opportunity Statement

Individuals seeking employment at Orna Therapeutics are considered without regards to race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation.