Scientist, Analytical CMC (RM/SM Support), Process and Analytical Development

Translate Bio

Massachusetts, US
  • Job Type: Full-Time
  • Function: Manufacturing
  • Post Date: 06/08/2021
  • Website: translate.bio
  • Company Address: 790 Memorial Drive Suite 203, Cambridge, MA, 02139

About Translate Bio

Translate Bio is focused on pioneering the translation of RNA science into therapeutics promoting healthy gene expression in people living with debilitating genetic diseases. The company’s RNA platforms for powering endogenous therapeutic protein production is applicable to a broad range of diseases caused by insufficient protein production, including rare diseases of the liver, lung and central nervous system (CNS).

Job Description

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, 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

    Manage analytical chemistry activities both internally and at external contract laboratories for critical raw materials and starting materials.
    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/MS degree in 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 managing 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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Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.