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Senior Engineer II, Applied Technologies

Moderna

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Location:
United States , Norwood

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Category:
IT - Software Development

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Contract Type:
Employment contract

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Salary:

145900.00 - 234200.00 USD / Year
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Job Description:

This high-impact individual contributor role will lead the strategy and deployment of Process Analytical Technology (PAT) across Moderna’s mRNA drug substance and drug product platforms. You will architect and implement cutting-edge inline, online, and at-line analytical tools that unlock real-time monitoring and data-driven control from early-stage development through GMP manufacturing. Working across functional boundaries, you will build the digital and analytical backbone of next-generation bioprocessing. This is a unique opportunity to operate at the intersection of automation, advanced analytics, and mRNA science — and to shape how Moderna integrates Generative AI tools and intelligent control systems into its manufacturing future.

Job Responsibility:

  • Lead the end-to-end PAT and control strategy, ensuring cross-platform consistency and alignment with Moderna’s digital and automation roadmaps
  • Design, deploy, and maintain a diverse suite of spectroscopic, chromatographic, and sensor technologies (e.g., Raman, FTIR, UPLC, rapid sterility, pH/DO micro sensors)
  • Develop chemometric models and real-time dashboards linking process parameters with critical quality attributes
  • Serve as a technical lead on integration of PAT tools into Moderna’s digital ecosystem — including data lakes, electronic batch records (eBR), and advanced process control layers
  • Author and lead technology transfer packages to internal GMP sites and external partners, ensuring seamless comparability and calibration approaches
  • Collaborate closely with analytical development, MS&T, process automation, digital, engineering, quality, and regulatory teams to ensure PAT solutions are seamlessly manufacturable and inspection-ready
  • Drive continuous improvement initiatives that reduce cycle times, enhance right-first-time metrics, and improve overall process robustness
  • Mentor staff and champion a scientific culture of curiosity, innovation, and excellence
  • Translate complex analytical and regulatory requirements into integrated solutions aligned with Moderna’s next-gen manufacturing platforms
  • Travel up to 10%, supporting deployment at domestic and international manufacturing sites

Requirements:

  • Ph.D. in Chemical/Biomedical Engineering, Analytical Chemistry, or related discipline with 2+ years, OR M.S. with 8+ years, OR B.S. with 10+ years of relevant industrial experience
  • Hands‑on experience developing and implementing PAT tools in biopharmaceutical or advanced ‑therapy manufacturing environments, including sensor specification, installation, and data ‑modelling, and technology transfer
  • Proficient in multivariate data analysis/chemometrics tools (SIMCA, Unscrambler, Python, R) and integration with process automation systems, manufacturing data platforms, and communication protocols (e.g. DeltaV, SynTQ, PI AF, OPC UA)
  • Strong understanding of Design of Experiment (DoE), cGMP, Quality by Design principles, and process validation fundamentals

Nice to have:

  • Demonstrated authorship of CMC regulatory submissions (IND, IMPD, BLA/MAA) and participation in health authority interactions related to PAT packages, real-time release testing, and continuous manufacturing
  • Experience with life cycle management, including GMP compliance and training
  • Familiarity with expedited regulatory pathways, EU GMP Annex 1, ATMP/CGT guidances, and relevant ICH (e.g. Q8, Q9, Q10, Q12, Q13)
  • Expertise with mRNA, lipid nanoparticle formulation, or other nucleic acid-based modalities
  • Experience deploying PAT for personalized or small batch therapeutics
  • Lean/Six Sigma Green Belt (or higher) and a track record of driving efficiency improvements in GMP settings
  • Exceptional communication skills and a collaborative mindset focused on patient impact
  • A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative
What we offer:
  • Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needs
  • A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
  • Family planning benefits, including fertility, adoption, and surrogacy support
  • Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
  • Savings and investment opportunities to help you plan for the future
  • Location-specific perks and extras
  • Annual discretionary bonus, other incentive compensation, or equity award

Additional Information:

Job Posted:
May 03, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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