Sr. Engineer II, Process and Product Development - Clinical

Job description

The Role Moderna is seeking an experienced process development engineer to join the Process and Product Development - Clinical organization. The team develops, scales, and transfers processes for recombinant enzymes, proteins, DNA, and RNA that support Moderna's clinical and commercial portfolio. This role is based at Moderna's Norwood, MA site and will initially focus on downstream process development for recombinant enzymes produced primarily in Escherichia coli (E. coli). The Sr. Engineer II will design, optimize, characterize, scale, and transfer robust processes across the downstream recovery train, including cell lysis, clarification, filtration, chromatography, ultrafiltration/diafiltration, concentration, and buffer exchange. The successful candidate will apply engineering principles, protein and biomolecule chemistry, statistical methods, and strong experimental judgment to build process understanding, improve product quality and recovery, define appropriate operating ranges and control strategies, and support technology transfer. Over time, the role may apply these capabilities to additional protein, DNA, RNA, or related process-development programs. Here’s What You’ll Do Lead the definition, development, and implementation of moderately complex process and product development initiatives in collaboration with cross-functional CMC partners. Design, execute, analyze, and document laboratory studies to develop robust and scalable downstream processes, with an initial emphasis on recombinant enzymes produced in microbial systems. Develop and optimize integrated process trains using unit operations such as cell lysis, clarification, centrifugation, depth and membrane filtration, chromatography, ultrafiltration/diafiltration, concentration, and buffer exchange. Define process flows, critical process parameters, operating ranges, scale-down models, and control strategies using engineering fundamentals, risk assessment, and statistically rigorous experimentation. Develop process understanding and impurity-control strategies to achieve required product quality, activity, recovery, stability, and manufacturability. Apply Design of Experiments, multivariate analysis, process-data trending, mass balances, and structured problem solving to guide process decisions and resolve technical challenges. Lead or support technology transfer to internal and external manufacturing sites and provide technical support for manufacturing readiness, investigations, and continuous improvement. Author and review development reports, technical assessments, process descriptions, protocols, comparability assessments, transfer documents, and regulatory-support documentation. Communicate technical findings and recommendations to cross-functional stakeholders and provide mentorship and guidance to less experienced colleagues. Maintain accurate and timely experimental records, current knowledge of relevant scientific and industry trends, and compliance with written procedures and regulatory expectations. Perform laboratory work in an on-site environment and occasionally lift up to 30 pounds. Additional duties may be assigned as needed. Here’s What You’ll Bring to the Table (Basic Qualifications) PhD in Chemical Engineering, Biochemical Engineering, Bioprocess Engineering, Biotechnology, Biochemistry, Protein Chemistry, Molecular Biology, or a related field with at least 2 years of relevant industry experience; or MS with at least 8 years; or BS/BA with at least 10 years of relevant industry experience. Demonstrated experience developing downstream processes for recombinant proteins and/or enzymes across multiple unit operations, including lysis or product release, clarification, filtration, chromatography, and ultrafiltration/diafiltration. Hands-on experience designing, executing, analyzing, and interpreting complex process-development experiments in a laboratory environment. Strong understanding of protein chemistry, protein or enzyme stability, impurity behavior, process recovery, and scale-up principles. Experience solving complex technical problems using engineering judgment and data-based decision-making. Knowledge of statistical analysis and experimental design applied to process development. Excellent written and verbal communication skills, including the ability to explain complex technical information and collaborate across diverse teams. Here’s What You’ll Bring to the Table (Preferred Qualifications) Advanced training in chemical, biochemical, or bioprocess engineering with substantial experience in protein or enzyme process development. Experience developing downstream processes for recombinant proteins or enzymes produced in E. coli or other microbial expression systems. Broad hands-on expertise across downstream unit operations, including cell disruption, clarification, centrifugation, depth or membrane filtration, preparative chromatography, ultrafiltration/diafiltration, concentration, and buffer exchange. Understanding of how upstream, harvest, and feed-stream conditions affect downstream recovery, impurity clearance, filtration, chromatography, and overall manufacturability. Expertise with preparative protein chromatography, including affinity, ion exchange, mixed-mode, hydrophobic interaction, or other relevant separation approaches. Experience developing control strategies for host-cell proteins, residual DNA, endotoxin, aggregates, process additives, and product-related variants. Experience connecting process conditions and product quality attributes with protein or enzyme activity, recovery, purity, and stability. Experience with Design of Experiments, JMP, multivariate analysis, QbD, process characterization, robustness studies, scale-up, and scale-down modeling. Experience transferring bioprocesses into clinical or commercial manufacturing and supporting investigations or process improvements. Familiarity with downstream processing of DNA, RNA, oligonucleotides, or other biomolecules is beneficial. Demonstrated ability to independently lead technical workstreams, influence cross-functional strategy, and mentor less experienced colleagues. A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative. Our Working Model As we build our company, we have always believed that an in-person culture is critical to our success. This role is 100% onsite, reflecting the importance of being physically present to support the work, collaborate closely with colleagues, and contribute to our site-based operations. Working onsite enables real-time collaboration, strong team connections, direct mentorship, and the hands-on partnership needed to deliver our mission. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact. Moderna is a smoke-free, alcohol-free, and drug-free work environment. Pay & Benefits At Moderna, we believe that when you feel your best, you can do your best work. That’s why our benefits and well-being resources are designed to support you—at work, at home, and everywhere in between. 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 The salary range for this role is $130,800.00 - $209,400.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual’s position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, cert