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 Sr/Scientist Molecular Biology will be responsible for oversight of internal and external development and GMP manufacturing of critical reagents and custom raw materials for drug substance and drug product manufacturing of novel mRNA Lipid Nanoparticle formulations. This includes development and production of custom plasmids and critical drug substance enzymes.  This role will contribute to the CMC strategy within the Pharmaceutical Sciences group. The Biologics CMC Critical Raw Materials, Scientist will lead the effort to build Translate Bio’s competency in managing outsourced biologics efforts, including the production and characterization of cell banks, enzymes, plasmids, and other custom biologics.
 
This individual should have knowledge of traditional biologics manufacturing processes as well as plasmid manufacture.  This includes cell line selection, master cell banks, working cell banks, upstream cell culture, downstream purification, and analytical characterization. The scientist should also have an understanding of working in an FDA regulated environment and producing materials under cGMP’s for human use.  Finally, the individual should have the knowledge capable of serving as a technical SME for an internalization of such manufacturing efforts.

Job Responsibilities
  • Serve as lead technical representative to ensure critical raw material supplies are manufactured to phase-appropriate technical specifications.
  • Serve as the technical subject matter expert for Technical Operations on GMP production of linearized plasma DNA and enzymes used the manufacturing of mRNA drug substance.
  • Oversee the technology transfer and outsourcing of critical biological reagents and characterization to CMO’s/CRO’s. This will include vendor identification, evaluation, and selection while ensuring alignment with the drug substance and drug product timelines.
  • Review CMO/CRO batch records for our critical reagents and custom raw materials to ensure robust processes are developed that are capable of meeting quality standards.
  • Ability to provide technical support and resolve scale-up and manufacturing issues, develop solutions to improve process efficiency and product quality.
  • Work with Analytical Development and Quality Control to ensure characterization, including stability, of critical reagents is comprehensive.
  • Review and edit contract, supply agreements, statements of work, etc.
  • Support and contribute to IND and IMPD filings as well as other regulatory documentation.
  • Work with Supply Chain to support Vendor Change Notifications (VCN), and closeout of Change Controls for VCNs, and inventory management with respect to VCNs.
  • Assume additional responsibilities as assigned.
Required Skills & Qualifications
  • A PhD in Molecular Biology, Biochemical Engineering or related field with 10 years relevant industry experience. Consideration will be given to BS/MS with significant experience in all aspects required for this position.
  • Knowledge and experience with GMP production of plasmid DNA and associated purification processes.
  • Expertise in the creation and maintenance of regulatory compliant Working and Master Cell Banks.
  • Experience in vendor search, evaluation, selection, and management.
  • Ability to work independently and effectively.
  • Strong familiarity with cGMP and ICH Guidelines (including Q7A, Q11).
  • Uses leading-edge knowledge of principles, concepts and practices and/or techniques to lead complex projects within a department team.
  • Strong problem-solving abilities.
  • Ability to prioritize and deliver on tight timelines
  • Strong written and oral communications skills, with demonstrated experience in cross-functional and timely communication. Strong and collaborative work ethic; must be a self-starter and persistent in achieving objectives to support Translate Bio’s scientific and business goals.
  • Highly organized, exceptional attention to detail, and strong proficiency in documentation skills.
  • Results oriented and demonstrates a focus on achieving (business) results.
  • When appropriate, the ability to travel (U.S./ Int’l) to execute business requirements.
Translate Bio is committed to equal employment opportunity. All applicants must have authorization to work in the U.S.
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