Engineer II, Process Development
About The Position
Moderna is seeking an Individual to join the Late-Stage Execution team within the Process and Product Development – Registrational organization. This role will support late-stage process characterization, technology transfer, validation readiness, and commercial regulatory filing activities for Moderna’s mRNA medicines. The successful Candidate will contribute to the development and execution of robust, scalable, and well-characterized manufacturing processes across RNA, LNP, and related unit operations. This is a lab-based role requiring strong experimental execution, technical documentation, data analysis, and cross-functional collaboration with Process Development, Analytical, Manufacturing, Quality, Regulatory, Supply Chain, and Program Management teams. This role is well suited for a proactive scientist or engineer who can independently plan and execute experiments, troubleshoot process challenges, maintain high-quality source documentation, and help translate process knowledge into regulatory-ready technical packages.
Requirements
- BS with minimum of 3+ years, MS with 1+ years of relevant industry experience in bioprocess development and/or manufacturing sciences with a degree in Chemical Engineering, Chemistry, Biochemical Engineering, Biochemistry or closely related scientific field.
- Background in process development (late-phase preferred) and/or process characterization
- Working knowledge of bioprocess engineering principles, process modeling, and Design of Experiment (DoE) statistical tools.
- Ability to plan and execute experiments independently with minimal guidance
- Excellent communication, presentation, and writing skills
- Creative/innovative/problem solver
Nice To Haves
- Experience with nanoparticle formulations or mRNA manufacturing
- Familiarity with nucleic acid and protein chemistry, enzyme kinetics, and analytical characterization of biomolecules
- Experience/education in biotechnology process/product development.
- Hands on experience with AKTA FPLC, Hamilton, Tangential flow filtration (TFF), HPLC/UPLC instrumentation and pump systems (e.g. Metler-Toledo).
Responsibilities
- Execute late-stage process characterization studies supporting registrational and commercial filings.
- Independently plan, execute, troubleshoot, and document experiments supporting RNA, LNP, and related process unit operations.
- Support development and evaluation of robust, scalable, and well-characterized manufacturing processes using Quality by Design (QbD) principles, risk assessments and experimental data.
- Contribute to process robustness studies, scale-down model development, scale-up studies, technology transfer, and process validation readiness.
- Analyze and interpret experimental data using appropriate statistical, visualization, and modeling tools.
- Maintain high-quality electronic lab notebooks, protocols, technical reports, and source documentation suitable for regulatory filings and inspection readiness.
- Collaborate cross-functionally with Analytical Development, Manufacturing, Quality, Regulatory, Supply Chain, and Program Management teams to meet program milestones.
- Present technical results, risks, and recommendations in internal and cross-functional forums.
- Collect, organize, archive, and coordinate process samples for downstream analytical testing.
- Identify process gaps, troubleshoot technical challenges, and propose practical, data-driven solutions.
- Ensure all activities are performed in accordance with site SOPs, GxP expectations, and environmental health and safety standards.
Benefits
- Competitive healthcare, 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 investments to help you plan for the future
- Location-specific perks and extras
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
