Senior Scientist, Pharmaceutical Development CMC (CONTRACT)

Orna Therapeutics; Watertown (MA); On-site; USD 100,000 - 130,000; Full time

Job summary

Orna Therapeutics is seeking a Senior Scientist in Pharmaceutical Development CMC to lead the analytical development for innovative therapies utilizing circular RNA technology. The role demands extensive experience in analytical methodologies and drug development, offering a chance to contribute to groundbreaking advancements in RNA therapeutics.

Qualifications

• 3-5 years of experience in the biopharmaceutical industry with a Ph.D.
• 8 years of experience in the biopharmaceutical industry with an M.S.
• Experience in a GxP environment for method qualification and validation.

Responsibilities

• Implement analytical testing strategy for circular RNA formulations.
• Develop and qualify analytical methods and perform characterization studies.
• Support method transfer to CROs and provide technical guidance.

Skills

HPLC

LC-MS

DLS

CE

Spectrophotometry

Education

Ph.D. or equivalent degree in analytical chemistry, biochemistry

M.S. or equivalent degree in analytical chemistry, biochemistry

Job description

Senior Scientist, Pharmaceutical Development CMC (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 are seeking an exceptional ContractSenior Scientist , Pharmaceutical Development CMC to join our CMC team to develop and validate analytical methods for the characterization of ORNA novel oRNA therapeutics. The ideal candidate will have drug development subject matter expertise with biologic, mRNA and/or gene therapy and provide leadership in developing strong analytical portfolio for ORNA therapeutics. They will support the design and execution of experiments and have relevant analytical development experience; possess strong oral and written communication capabilities; demonstrate excellent collaboration & interpersonal skills; and be adept at problem solving in a fast-paced environment.

Responsibilities

• Implement Orna’s analytical testing strategy for circular RNA and lipid nanoparticle formulations.
• Provide scientific leadership within and across functional areas that coordinate analytical activities and develop analytical strategy to support product development.
• Develop and qualify drug substance and drug product analytical methods and perform characterization studies.
• Build and develop internal analytical capabilities, as well as relationships with external organizations (CDMOs/CROs) to support in-process, release, stability, and characterization testing of drug products.
• Support method transfer to CROs and provide technical guidance/troubleshooting.
• Authorize, compile and support of CMC regulatory documents, including Module 3 pharmaceutical development and analytical sections.
• Ensure all analytical development aligned with the agency’s expectations and regulations.
• Review method procedures, method validation protocols and reports. Maintain knowledge of regulatory guidance.
• Support Analytical/Product Development in aspects of technology transfer, process scale-up, and process validation activities at contract organizations and with partners.
• Contribute to a positive and exciting work environment; contribute to a strong entrepreneurial and creative culture.

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 8 years of experience in the biopharmaceutical industry.
• Knowledge of analytical methodologies such as HPLC, LC-MS, DLS, CE, Spectrophotometry, and others.
• Knowledge of CMC and regulatory requirements for biologics, including ICH Quality Guidelines and appropriate cGMP authority guidelines and regulations
• Experience with development, qualification, validation, and transfer of analytical methods in a GxP environment to support process development, product characterization, release, stability studies, and other analytical studies.
• Experience with LNP, mRNA is highly desirable.
• Strong oral and written skills and the ability to manage third party vendors.

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.

We are unable to sponsor visas for contract roles.

Process Development & Analytical Sciences