Sr. Engineer II, Process and Product Development - Clinical

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.

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.

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.