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
Translate Bio is seeking a highly motivated individual to join the Process and Analytical Development group to drive products from research into the clinic. This leadership position will be responsible for leading analytical method development for mRNA therapeutics by working closely with our process development and production groups, developing novel methods, and improving the characterization of our DS and DP products throughout development. In addition, this individual will support QC with the transfer of methods to contract labs for GMP testing and the creation an internal QC lab. The individual will manage all aspects of the analytical development lab to ensure reliable internal testing is performed, including the management of methods, SOPs, protocols and method development reports. The individual will work cross-functionally with the Research, Process Development, Quality Control, and Manufacturing teams to ensure consistent characterization of Translate Bio’s mRNA drug products from research to the clinic, including the drafting and review of CMC sections and supporting documents for regulatory filings.

Job Responsibilities
  • Craft a strategic vision and lead a group of scientists to fully develop analytical methods that robustly characterize our mRNA drug substance and lipid nanoparticle drug products
  • Create analytical understanding to support robust clinical and ultimately commercial supply of all our platform products, as well as end-to-end characterization of our supply chain (key raw materials, reagents, and starting materials)
  • Develop a team with the abilities manage testing of multiple programs and continually advance the technology
  • Design, execute, and document analytical method development in support of process development, product release, stability, and product characterization of mRNA therapies
  • Ensure standard operating procedures, analytical test methods, and analytical sampling plans meet the highest industry standard
  • Assure appropriate laboratory controls for sample management, data integrity, reagents, and equipment
  • Review and approve method development and qualification reports
  • Work with internal and external (CMO and CRO) laboratories to assure robust method development, transfer, and execution in GMP and GLP settings
  • Selection and on-boarding of new testing labs to support release testing
  • Manage analytical tech transfer to contract labs and internal QC to complete GMP testing
  • Participate in laboratory investigations / deviations at vendor sites
  • Work cross-functionally and ensure a collaborative work environment with client groups, including Research, Process Development, Quality Control, and Manufacturing teams
  • Work cross functionally to develop phase-appropriate specifications for DS and DP
  • Author, review and approve IND, IMPD, BLA and MAA sections; participate in scientific advice preparations and meetings
  • Management of stability studies to support clinical and non-clinical candidates including data trending
  • Assume additional responsibilities as assigned
Required Skills & Qualifications
  • MS/PhD in Chemistry, Biochemistry, Biology or related discipline
  • 10+ years of experience in analytical method development and qualification of relevant methods
  • Experience leading complex, multi-disciplinary projects and teams during biotech drug development
  • Ability to lead a team of scientists to develop comprehensive analytical understanding of products in pre-clinical and clinical development
  • Expertise with analytical method development and qualification for mRNA products
  • Advanced hands-on experience with various analytical techniques including UPLC, CGE, ELISA, qPCR, Western blot, SDS page, particle size, and compendial test methods.
  • Experience preparing technical documents for internal distribution or inclusion in regulatory filings
  • Strong ability to present data in a variety of team settings and actively participate in departmental meetings as well as cross-functional area project teams
  • Strong interpersonal skills with the ability to motivate others, influence, and negotiate difficult situations
  • Self-motivated, detail-oriented, excellent interpersonal and writing skills
  • Knowledge of QbD approaches to analytical method development including risk assessment, DOE, and statistical analysis
  • Ability to function efficiently and independently in a changing environment
  • Well organized and ability to coordinate testing for numerous clinical candidates at multiple contract sites.
Translate Bio is committed to equal employment opportunity. All applicants must have authorization to work in the U.S.
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