Associate Scientist, Analytical CMC (Raw /Starting Materials)
Company Overview
We are a leading mRNA therapeutics company developing a new class of potentially transformative medicines to treat diseases caused by protein or gene dysfunction. Using our proprietary mRNA therapeutic platform (MRT), we create mRNA that encodes functional proteins. Our mRNA is delivered to the target cell where the cell’s own machinery recognizes it and translates it, restoring or augmenting protein function to treat or prevent disease.
At Translate Bio, we’re also passionate about our five core values: Put People First, Be Approachable, Act as One, Be Tenacious, and Be Bold. These values embody our culture and underscore our mission to bring mRNA therapeutics to all.
Job Summary
The Associate Scientist, Analytical CMC contributes to the analytical development function within CMC and overall CMC strategy of drug development at Translate Bio. The scientist supports the development, validation and transfer of analytical methodologies for incoming raw materials, starting materials, drug substance, and stability testing. The scientist has expertise in biologics, biochemistry, synthetic intermediates, and analytical chemistry.
Job Responsibilities
- Help manage analytical chemistry activities both internally and at external contract laboratories for critical raw materials and starting materials.
- Guide CRO to design and perform phase-appropriate method development, testing, and validation.
- Manage product stability study programs, trending data.
- Demonstrate extensive knowledge in state-of-the-art analytical technologies
- Authorize/review analytical method development reports, validation protocols/reports, instructions/SOP’s for relevant analytical functions.
- Coordinate internal analytical development laboratory and analytical personnel to support pipeline programs
- Provide technical advice to analytical scientists and associates to assure the highest quality of data is developed and presented
Required Skills & Qualifications
- BS degree in analytical chemistry or biochemistry with 5+ years’ experience or MS degree with 0-2 years’ experience.
- Excellent scientific knowledge in analytical/biology/biochemistry chemistry with analytical development experience for drug substance and drug product.
- Familiarity with a full range of analytical techniques for characterization of biologics and synthetic intermediates including RP/IEX/SEC HPLC, UPLC, LCMS, Karl Fisher, GC, mass spectrometry, solid state characterization, CE spectrophotometry.
Translate Bio is committed to equal employment opportunity. All applicants must have authorization to work in the U.S.