Engineer II, Process Development

ModernaTX • Norwood, MA

5h • Onsite

About The Position

The Pilot Scale Operations team is seeking a highly skilled and motivated Engineer II to support pilot-scale production of nucleic acid and formulated nucleic acid products. This role is responsible for scaling processes from bench to pilot scale and generating DNA/RNA/LNP/DP for developmental and tox studies, enabling first-time filings and commercial updates. This position requires both independent execution and cross-functional collaboration to implement robust, scalable processes. The Engineer II will operate with increasing ownership of technical projects, contribute to technology transfer activities, and proactively identify and resolve process challenges in a fast-paced environment.

Requirements

• BS in Chemical/Biomedical Engineering, Pharmaceutical Sciences, Biochemistry, Biology, or related discipline with 2+ years of experience, or MS with relevant experience
• Hands-on experience in process development or operations, including one or more: enzymatic reactions, chromatography, tangential flow filtration, formulation of biologics
• Demonstrated ability to execute and troubleshoot processes independently in a fast-paced environment
• Strong communication skills with the ability to collaborate effectively across cross-functional teams

Nice To Haves

• BS with 3+ years or MS with 2+ years of industry experience
• Experience with mRNA/DNA synthesis, LNP formulation, and/or drug product processes
• Experience in technology transfer and scaling-up of processes
• Demonstrated ability to own and drive technical projects or workstreams
• Ability to analyze complex datasets and translate findings into actionable improvements
• Proven ability to expand technical skillset and operate across multiple process areas

Responsibilities

• Lead or contribute to technical projects with increasing ownership related to DNA/RNA/LNP/DP processes, including technology transfer, process optimization, and continuous improvement initiatives
• Lead batch execution, propose troubleshooting in real time to ensure successful outcomes
• Propose and implement solutions to technical challenges, gaps, and process deviations
• Collaborate cross-functionally with Process Development, Analytical, and other teams to support tech transfer and process robustness
• Distill and communicate batch related data to inform process improvements and decision-making
• Author and optimize technical documentation, including SOPs and protocols, and support training of team members
• Provide operational leadership during batches and guidance to junior team members and aligning stakeholders on project goals
• Apply operational excellence principles to improve workflows, lab organization, and execution efficiency
• Identify and mitigate risks, including safety, process, and operational risks; escalate when appropriate
• Maintain compliance with GLP-enabling practices, safety procedures, and environmental regulations

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level