Sr. Engineer II, Process and Product Development - Clinical

Moderna; Norwood (MA); On-site; USD 140,000 - 210,000; Full time

Job summary

Moderna is seeking an experienced process development engineer to join the Clinical Process and Product Development organization at the Norwood, MA site. The Sr. Engineer II will shape downstream processes for recombinant enzymes produced in E.

coli, including lysis, clarification, filtration, chromatography, and ultrafiltration. You will design experiments, build process understanding, and support technology transfer to manufacturing.

Qualifications

• PhD in Chemical Engineering, Biochemical Engineering, Bioprocess Engineering, Biotechnology, Biochemistry, Protein Chemistry, Molecular Biology, or related field with at least 2 years of industry experience; or MS with at least 8 years; or BS/BA with at least 10 years of 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.

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 and scalable downstream processes.
• Develop and optimize integrated process trains using unit operations such as cell lysis, clarification, centrifugation, 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 and statistically rigorous experimentation.
• Develop process understanding and impurity-control strategies to achieve product quality, activity, recovery, stability, and manufacturability.
• Lead or support technology transfer to internal and external sites and provide technical support for readiness, investigations, and continuous improvement.
• Prepare and review development reports, assessments, process descriptions, protocols, comparability assessments, transfer documents, and regulatory-support documentation.
• Communicate findings to cross-functional stakeholders and mentor less experienced colleagues.

Skills

Communication skills

Analytical thinking

Statistical analysis

Engineering judgment

Experiment design

Education

PhD in Chemical/Biochemical/Bioprocess Engineering or related field

MS in related field with 8+ years experience

BS/BA with 10+ years experience

Tools

Design of Experiments

Multivariate analysis

Process transfer documentation

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. celli 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.