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 Scientist 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 and starting materials, including plasmids and lipids. The scientist has expertise in biologics, biochemistry, synthetic intermediates, and analytical chemistry.

Job Responsibilities
  • 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.
  • Develop phase-appropriate quality control strategy, including new analytical technology and methods for critical raw materials and starting materials. 
  • Manage raw material stability study programs and develop stability trending database.
  • Demonstrate extensive knowledge in state-of-the-art analytical technologies; Become the subject matter expert for new instruments brought in-house, such as sequencer, LC/MS, and GC-MS.
  • Authorize/review analytical method development reports, validation protocols/reports, instructions/SOPs for relevant analytical functions, and analytical sections in IND and IMPD filings
  • Manage internal analytical development laboratory projects 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/MS degree in organic chemistry, analytical chemistry, or biochemistry with 8+ years, or PhD with 2-5 years relevant 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.
  • Experienced in CMC product development process including cGMP manufacturing, validation, and process development.
  • Demonstrated competency and hands-on experience of typical chemistry manufacturing and controls (CMC) activities.
  • Experience drafting analytical sections of INDs and NDAs.
  • Knowledge of GMP/ICH/FDA regulations is preferred
  • Experience working with CROs and CMOs.
  • Previous experience/knowledge of routine mRNA and LNP production and testing in support of Process Development and Research activities is preferable, but not required.
  • Reviews, interprets and communicates data cross-functionally within CMC and project teams.
  • Ability to meet deadlines and demonstrate effective use of time.
  • Ability to be flexible and responsive to change, be a results-driven problem solver.
Translate Bio is committed to equal employment opportunity. All applicants must have authorization to work in the U.S.
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