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

Orna Therapeutics; Watertown (MA); On-site; USD 80,000 - 110,000; Full time

Job summary

Join a pioneering biotechnology startup revolutionizing RNA therapeutics in a collaborative environment. As an Associate Scientist/Senior Associate Scientist, you will play a critical role in developing and validating analytical methods for novel oRNA therapeutics. This role offers the opportunity to work on groundbreaking therapies targeting complex diseases, and to contribute to a vibrant team dedicated to advancing healthcare solutions. If you are passionate about making a meaningful impact in the field of biotechnology, this is the perfect opportunity for you.

Benefits

Collaborative Work Environment

Professional Development Opportunities

Qualifications

• 5+ years of experience in analytical chemistry or biochemistry.
• Hands-on experience with HPLC and other analytical methodologies.

Responsibilities

• Implement analytical testing strategy for RNA and lipid formulations.
• Develop and qualify analytical methods for drug substances.

Skills

HPLC

LC-MS

DLS

CE

Spectrophotometry

Analytical Development

Communication Skills

Education

BS in Analytical Chemistry

MS in Biochemistry

Tools

GxP Environment

Regulatory Knowledge

Job description

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

Join to apply for the Associate Scientist/Senior Associate Scientist, Pharmaceutical Development CMC (CONTRACT) role at Orna Therapeutics.

Orna Therapeutics, an innovative biotechnology startup based in Watertown, MA, is dedicated to developing groundbreaking therapies for diseases that current approaches cannot address. Using our pioneering circular RNA technology developed at MIT, we are advancing the next generation of RNA therapeutics, targeting complex diseases such as autoimmune disorders, B cell malignancies, sickle cell disease, and more.

We seek an Contract Associate Scientist/Senior Associate Scientist in Pharmaceutical Development CMC to support the development and validation of analytical methods for ORNA's novel oRNA therapeutics. The ideal candidate is motivated, capable of independently executing experiments efficiently and creatively, and possesses strong analytical development experience, excellent communication skills, and the ability to collaborate effectively in a fast-paced environment.

Responsibilities

• Implement Orna’s analytical testing strategy for circular RNA and lipid nanoparticle formulations.
• Develop and qualify drug substance and drug product analytical methods, including characterization studies.
• Build and enhance internal analytical capabilities and manage relationships with external organizations (CDMOs/CROs) for testing support.
• Support method transfer, provide technical guidance, and troubleshoot as needed.
• Review method procedures, validation protocols, and reports, maintaining regulatory knowledge.
• Generate, interpret, and present data to cross-functional R&D teams.
• Serve as an analytical SME for investigations and OOS/OOT issues.
• Assist in technology transfer, process scale-up, and validation activities at contract organizations and partners.
• Contribute to a positive, entrepreneurial, and innovative work environment.

Qualifications

• BS/MS in analytical chemistry, biochemistry, or related field with 5+ years of relevant experience.
• Hands-on experience with analytical methodologies such as HPLC, LC-MS, DLS, CE, Spectrophotometry; strong HPLC expertise required.
• Knowledge of CMC and regulatory requirements for biologics, including ICH guidelines and cGMP regulations.
• Experience with development, qualification, validation, and transfer of analytical methods in a GxP environment.
• Experience with LNP and mRNA is highly desirable.
• Excellent communication skills and experience managing third-party vendors.

Why Orna?

At Orna Therapeutics, we foster a collaborative environment where individuals can grow and make a meaningful impact on healthcare. Join us as we revolutionize RNA therapeutics and improve patient lives worldwide.

Equal Employment Opportunity

We consider all applicants without regard to race, color, religion, national origin, age, sex, marital status, disability, veteran status, gender identity, or sexual orientation.