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 a leading mRNA therapeutics company developing a new class of potentially transformative medicines to treat, or prevent, debilitating or life-threatening diseases. BioAnalytical studies are an opportunity to investigate the biological consequences of mRNA medicines in preclinical studies, through clinical development. BioAnalytical studies can be used in multiple ways, for example to assess the delivery of the mRNA, expression of the encoded protein and biological changes that may indicate undesired effects or potential benefits.
 
The Director, BioAnalytical, is within the Translational Sciences group reporting to the SVP Translational Sciences. The Director, BioAnalytical, is responsible for collaborating with teams across R&D to evaluate the areas where biomarkers could have an impact, providing expert input to design decision making biomarker studies and through leading the BioAnalytical team produce timely, quality, data on budget.

Job Responsibilities
  • Develop and maintain a bioanalytical strategy to produce decision making data that is aligned with R&D objectives
  • Lead and grow a comprehensive BioAnalytical group to design, complete and analyze biomarker data for all stages of discovery and development for mRNA therapeutics
  • Collaborate with the broader Translational Science group, discovery and clinical teams to understand the objectives of each and develop aligned bioanalytical plans 
  • Provide inspirational scientific leadership of the BioAnalytical team including assay method development, characterization, validation and method transfer of sophisticated, fit for purpose, biomarkers for a range of analytes (e.g. proteins, lipids, oligonucleotides, mRNA, and ADA)
  • Enable Translational Science studies by initiating contracts and POs, reviewing SOWs, and working closely with CROs and various internal teams to monitor study progress
  • Presenting plans, progress, and risks
  • Supporting and guiding senior executive decision-making processes
  • Write, review and approve bioanalytical protocols, reports, associated summaries, regulatory sections and associated documentation
  • Willing to assume additional responsibilities as assigned 
Required Skills & Qualifications
  • PhD in a pharmaceutical sciences related field
  • 10+ years of experience working in a Bioanalytical role within the pharmaceutical or biotechnology industry is required
  • Detailed knowledge of drug discovery and development with the ability to apply independent judgement and direction to the leadership of Bioanalytical studies and the Bioanalytical team
  • Evidence of scientific/technical leadership in a range of BA methods to support small molecule, oligonucleotide, mRNA, proteomics, and immunogenicity assessments.
  • Extensive experience in the outsourcing and external oversight of regulated (GLP, GCP) Bioanalytical studies to support nonclinical and clinical activities.
  • Demonstrate knowledge of regulatory requirements and expectations for Bioanalytical packages to support regulatory filings and clinical studies including thorough knowledge of GLP, GCP, ICH and other applicable guidelines
Translate Bio is committed to equal employment opportunity. All applicants must have authorization to work in the U.S.
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