Engineer II, Process Development

Moderna is a biotechnology company focused on developing messenger RNA (mRNA) based medicines. They are seeking an Engineer II to join their Late-Stage Execution team, where the role involves supporting late-stage process characterization, technology transfer, and regulatory filing activities for mRNA medicines.

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

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
• 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)