Senior Manager, Pharmaceutical Development CMC

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 exceptional Senior Manager, Pharmaceutical Development CMC to join our CMC team to lead external GMP analytical services and pharmaceutical development for ORNA lead pipeline candidates. The ideal candidate will have drug development subject matter expertise with biologic, mRNA/oRNA and/or gene therapy and provide leadership in developing strong analytical portfolio for ORNA therapeutics. They will possess strong oral and written communication capabilities; demonstrate excellent collaboration & interpersonal skills; and be adept at problem solving in a fast-paced environment.

Responsibilities

• Lead the external development of the analytical CMC strategy at CRO’s, execute project planning, set priorities, and assure timelines and high quality of deliverables for CMC programs.
• Lead method development, method transfer and validation activities as well as routine GMP testing, ensure all analytical development aligned with the agency’s expectations and regulations.
• Review and approve analytical method procedures, validation protocols and reports, raw data, stability protocols and reports, perform data trending, data interpretation for CMC management review.
• Manage CRO’s budget, workflow, timelines to align with CMC timelines.
• Provide scientific leadership within and across functional areas that coordinate analytical activities and develop analytical strategy to support product development.
• Authorize, compile and support of CMC regulatory documents, including Module 3 pharmaceutical development and analytical sections.
• Identify and implement improvements that optimize pharmaceutical development and analytical services.
• Develop templates and other tools to continuously improve information interpretation and summaries from original raw data sources.
• Lead and develop other team members as needed.
• Contribute to a positive and exciting work environment; contribute to a strong entrepreneurial and creative culture.
• Availability to travel if/when needed.
  
  

Qualifications

• Ph.D. (or equivalent degree) in analytical chemistry, biochemistry or a relevant scientific discipline and 3-5 years of experience in the biopharmaceutical industry, or
• M.S. (or equivalent degree) in analytical chemistry, biochemistry or a relevant scientific discipline and 7 years of experience in the biopharmaceutical industry, or
• B.S. (or equivalent degree) in analytical chemistry, biochemistry or a relevant scientific discipline and 10 years of experience in the biopharmaceutical industry
• Knowledge of cGMP, understanding of analytical regulatory expectations.
• In-depth understanding of analytical techniques, knowledge of analytical methodologies such as HPLC, LC-MS, DLS, CE, Spectrophotometry, and others for characterization of RNA and LNP.
• Strong knowledge of CMC and regulatory requirements for biologics, including ICH Quality Guidelines and appropriate cGMP authority guidelines and regulations.
• Must have experience with regulatory submission.
• Adept in development, qualification, validation, and transfer of analytical methods in a GMP environment to support process development, product characterization, clinical material release, stability studies, and other pharmaceutical development and analytical studies.
• Experience with LNP, mRNA/oRNA is highly desirable.
• Strong oral and technical writing skills.
• Proven records of management of third-party vendors.
• 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.