Sr. Engineer II, Process and Product Development - Clinical (Biotech)

Location: 100% onsite at the Norwood, Massachusetts site, United States.

Salary: $130,800–$209,400 per year, plus potential annual bonus, incentive compensation, or equity.

Company

hirify.global develops an mRNA technology platform and medicines, with this role supporting clinical and commercial process development for recombinant enzymes, proteins, DNA, and RNA.

What you will do

• Lead moderately complex process and product development initiatives with cross-functional CMC partners.
• Design, execute, analyze, and document laboratory studies for robust and scalable downstream processes, initially focused on recombinant enzymes from microbial systems.
• Develop and optimize process trains covering 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 risk assessment and statistically rigorous experimentation.
• Develop impurity-control strategies to achieve required product quality, activity, recovery, stability, and manufacturability.
• Support technology transfer, manufacturing readiness, investigations, continuous improvement, technical documentation, regulatory support, stakeholder communication, and mentorship.

Requirements

• PhD in Chemical Engineering, Biochemical Engineering, Bioprocess Engineering, Biotechnology, Biochemistry, Protein Chemistry, Molecular Biology, or a related field plus at least 2 years of relevant industry experience; or MS plus at least 8 years; or BS/BA plus at least 10 years.
• 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 explaining complex technical information and collaborating across diverse teams.

Nice to have

• Advanced training in chemical, biochemical, or bioprocess engineering with substantial protein or enzyme process-development experience.
• Experience with recombinant proteins or enzymes produced in E. coli or other microbial expression systems.
• Broad expertise in 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 manufacturability.
• Expertise in preparative protein chromatography, including affinity, ion exchange, mixed-mode, hydrophobic interaction, or related separation approaches.
• Experience with 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; DNA, RNA, oligonucleotide, or other biomolecule processing experience is beneficial.
• Ability to independently lead technical workstreams, influence cross-functional strategy, and mentor less experienced colleagues.

Culture & Benefits

• 100% onsite work with hands-on laboratory collaboration, direct mentorship, and site-based operations.
• Smoke-free, alcohol-free, and drug-free work environment.
• Healthcare and voluntary benefits, fitness, mindfulness, and mental health resources.
• Family planning support, including fertility, adoption, and surrogacy benefits.
• Paid time off including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown.
• Savings and investment programs plus location-specific perks.