Sr. Engineer II, Process and Product Development - Clinical

ModernaTX • Norwood, MA

18d • $130,800 - $209,400 • Onsite

About The Position

Moderna is seeking an experienced process development engineer to join its Process and Product Development - Clinical organization. The team develops, scales, and transfers processes for recombinant enzymes, proteins, DNA, and RNA supporting Moderna’s clinical and commercial portfolio. Based at the Norwood, Massachusetts site, this role will initially focus on downstream process development for recombinant enzymes produced primarily in Escherichia coli (E. coli). The engineer will design, optimize, characterize, scale, and transfer robust downstream processes, applying engineering principles, biomolecule chemistry, statistical methods, and experimental judgment to build process understanding, improve product quality and recovery, establish operating ranges and control strategies, and support technology transfer. The work may later extend to additional protein, DNA, RNA, or related process-development programs.

The role leads and supports moderately complex process and product development initiatives with cross-functional CMC partners. It involves laboratory experimentation and documentation, development of integrated downstream process trains, process characterization and control-strategy development, technical problem-solving, and support for technology transfer and manufacturing readiness. The engineer also prepares and reviews technical and regulatory-support documents, communicates findings to stakeholders, and provides mentorship to less experienced colleagues. Laboratory work is performed onsite, and the role may occasionally require lifting up to 30 pounds.

The position is 100% onsite at Moderna’s Norwood, MA site. The work environment is smoke-free, alcohol-free, and drug-free. The stated salary range is $130,800 to $209,400. The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or an equity award, subject to plan eligibility and individual performance.

Requirements

• PhD in Chemical Engineering, Biochemical Engineering, Bioprocess Engineering, Biotechnology, Biochemistry, Protein Chemistry, Molecular Biology, or a related field and at least 2 years of relevant industry experience; or an MS and at least 8 years; or a BS/BA and 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.

Nice To Haves

• 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.
• Demonstrated ability to independently lead technical workstreams, influence cross-functional strategy, and mentor less experienced colleagues.
• Desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.

Responsibilities

• Lead the definition, development, and implementation of moderately complex process and product development initiatives with cross-functional CMC partners.
• Design, execute, analyze, and document laboratory studies to develop robust, scalable downstream processes, initially emphasizing recombinant enzymes produced in microbial systems.
• Develop and optimize integrated process trains involving 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 onsite environment and occasionally lift up to 30 pounds.
• Perform additional duties as needed.

Benefits

• Competitive healthcare and voluntary benefit programs.
• Fitness, mindfulness, and mental health support.
• Family planning benefits, including fertility, adoption, and surrogacy support.
• Paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown.
• Savings and investment programs.
• Location-specific perks and extras.
• Potential eligibility for an annual discretionary bonus, other incentive compensation, or an equity award, subject to company plan eligibility criteria and individual performance.

What This Job Offers

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