Senior Engineer II, Applied Technologies

The Role

Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology, with a diverse pipeline of development programs across various diseases.

As an employee, you'll be part of a continually growing organization, working alongside exceptional colleagues and strategic partners worldwide, contributing to global health initiatives.

Moderna's commitment to advancing the technological frontier of mRNA medicines ensures a challenging and rewarding career experience, with the potential to make a significant impact on patients' lives worldwide.

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.

Here's What You'll Do

Your key responsibilities will be:

• 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 (e ), and advanced process control layers.
• Author and lead technology transfer packages to internal GMP sites and external partners, ensuring seamless comparability and calibration approaches.

Your responsibilities will also include:

• 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.

The key Moderna Mindsets you'll need to succeed in the role:

• We digitize everywhere possible using the power of code to maximize our impact on patients. In this role, you'll be instrumental in embedding real-time PAT data into Moderna's digital infrastructure, laying the groundwork for automated insights and AI-driven decisions across the manufacturing network.
• We push past possible to be the best version of Moderna. You'll be expected to pioneer forward-thinking PAT strategies, challenge conventional approaches, and set new benchmarks for what real-time analytics can deliver in a fully digital biotech environment.

Here's What You'll Need (Basic Qualifications)

• 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. Delta
  
  V, 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.

Here's What You'll Bring to the Table (Preferred Qualifications)

• 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…