Moderna · 3 hours ago
Senior Engineer II, Applied Technologies
Moderna is a pioneering company revolutionizing medicine through mRNA technology. The role involves leading the strategy and deployment of Process Analytical Technology (PAT) across mRNA drug platforms, focusing on implementing cutting-edge analytical tools and driving continuous improvement initiatives.
BiotechnologyGeneticsHealth CareMedicalPharmaceuticalTherapeutics
Responsibilities
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
Qualification
Required
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
This position is site-based, requiring you to be at Moderna's site full-time. This position is not eligible for remote work
Preferred
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
Benefits
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
Company
Moderna
Moderna Therapeutics is a biotechnology company that specializes in vaccines and drug development.
Funding
Current Stage
Public CompanyTotal Funding
$4.56BKey Investors
Coalition for Epidemic Preparedness InnovationsAres ManagementU.S. Department of Health & Human Services
2025-12-18Grant· $54.3M
2025-11-20Post Ipo Debt· $600M
2024-07-02Grant· $176M
Recent News
2026-01-14
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