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 Senior Associate II of External Manufacturing will be responsible for ensuring our manufacturing processes and equipment are fit for purpose and that Drug Substance (DS), bulk Drug Product (bDP), and Finished Drug Product (FDP) are manufactured and released through our CMO partners according to phase-appropriate GMPs as needed to meet clinical demand. Assistance with the planning and oversight of tech transfer activities to ensure accurate translation of the process requirements into CMO Batch Records and SOPs will also be a primary focus.

Additional responsibilities will include: oversight of equipment commissioning and validation activities to ensure that a phase-appropriate validated state is established and maintained; collaborating with the Process Development and Process Engineering groups to provide support for tech transfer and process scale-up; and collaborating with the Process and Analytical Development and Quality Assurance functional groups to provide manufacturing and technical support facilitating CMO issue resolution, deviation / investigation closure, and product disposition.

Job Responsibilities
  • Act as a secondary or primary liaison with CMOs to ensure product manufacturing meets demand requirements for drug substance (DS), bulk drug product (bDP), and finished drug product (FDP). This will include communicating production demand planning to the CMO, Person-in-Plant activities, executed batch record review and issue resolution, deviation / investigation support and closure, and support of final product disposition as needed by QA.
  • Oversee and ensure success of Tech Transfer (TT) activities from Translate to CMO partners. This will include participating in vendor identification, evaluation, and selection, development of a comprehensive TT plan and schedule, ensuring accuracy of the Process Description, review of Master Batch Records and SOPs for alignment with the Process Description, review of Material Specifications, review and approval of raw material / consumables procurement plans, and coordination with Analytical Development on analytical method transfer / qualification / validation.
  • Participate with equipment commissioning and validation activities as needed and ensure that the ongoing validated status of process equipment is maintained in accordance with the validation master plan. Provide oversight of technical changes and lead end-to-end change control management related to technical issues, working cross-functionally as required.
  • Work in conjunction with the MS&T group on development and implementation of a QbD system to further process understanding for Translate’s products, facilitate trending and assessment of process parameters and quality attributes in order to set operational limits, specifications, and ultimately design space as products progress through clinical development, lead risk assessments (process / material / supplier), and utilize relevant process data to enhance risk-based supplier management.
  • Work with Process Engineering to provide support for TT and process scale-up activities. Assistance with hands-on execution of process development activities and demonstration batches may also be required.
  • Review and audit of CMO invoicing prior to approval for payment. Prepare campaign summary reports as required.
  • Assume additional responsibilities as assigned.
Required Skills & Qualifications
  • 1-3 years of relevant experience in the biopharmaceutical industry, 5 years total.
  • BS / MS in Engineering (preferred) or Life Sciences.
  • Experience in technical/process development and process/technology transfer as well as GMP manufacturing, focused on biologics or ATMPs.
  • Experience with global GxPs and industry guidance (esp., ICH Q6 – Q12) and compliance with these guidelines.
  • Experience in CMO management preferred.
  • Experience leading cross-functional teams to perform root cause analysis and problem solving on technical process issues (e.g., recurring deviations, quality-investigations, CAPA-studies) is preferred.
  • Excellent communication skills and ability to provide clear, concise descriptions of CMC/technical tasks, issues, schedule challenges, and proposed solutions
  • Results-oriented and demonstrates a focus on achieving business results.
  • Demonstrated ability to facilitate project team meetings, enhance cross-functional communication, support decision making, influence outcomes, and ensure alignment among internal and external stakeholders.
  • Familiar with current issues and Regulatory requirements related to manufacturing using single use equipment for drug substance and drug product production is a plus.
  • Ability to travel (U.S./ Int’l) ~25% of time, particularly when production campaigns are being done.
Translate Bio is committed to equal employment opportunity. All applicants must have authorization to work in the U.S.
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