Senior Process Engineer, Downstream Bioprocess (E. coli)

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

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.