Sr. Engineer, Process Development (Biotech)

Location: Cambridge, Massachusetts, or Thousand Oaks, California, United States. Domestic and international travel of up to 20% is required.

Salary: $115,494.60–$156,257.40 annual base salary.

Company

hirify.global is a biotechnology company developing, manufacturing, and delivering medicines for serious illnesses across oncology, inflammation, general medicine, and rare disease.

What you will do

• Develop, optimize, and scale synthetic and hybrid processes through bench- and kilogram-scale experimentation, process modeling, and simulation.
• Design and deploy models covering reaction kinetics, mass transfer, separations, distillation, isolation, drying, and hydrodynamic operations.
• Lead technology transfer activities, including process fit assessments, transfer documentation, manufacturing support, risk analysis, and process validation documentation.
• Evaluate manufacturing performance, troubleshoot process issues, and provide on-the-floor support during scale-up and commercialization.
• Apply engineering principles, design of experiments, statistical analysis, and economic and environmental assessment to identify process improvements.
• Collaborate with process development chemists, formulation scientists, and analytical chemists, while contributing to regulatory and quality activities.

Requirements

• Doctorate degree; or a master's degree and 2 years of engineering experience; or a bachelor's degree and 4 years of engineering experience; or equivalent experience through an associate's degree or high school diploma/GED.
• Experience with technology transfer, scale-up, and manufacturing of synthetic molecules in a regulated environment.
• Knowledge of engineering models, process improvement methods, data science, and advanced statistical analysis.
• Understanding of regulatory and cGMP requirements, laboratory and plant operations, and associated safety practices.
• Experience with bioprocessing unit operations for ADCs or oligonucleotides, HPAPI processing and containment, or linker-payload chemistry is preferred.
• Strong communication and presentation skills.

Nice to have

• Experience authoring CMC Module 3, RTQs, annual reports, and other regulatory documents.
• Knowledge of analytical and solid-state characterization techniques, including HPLC, GC, MS, NMR, FTIR, LOD, TOC, FBRM, and particle size determination.
• Proficiency with multiple first-principles modeling platforms.

Culture & Benefits

• Collaborative, innovative, and science-based work environment.
• Health, dental, vision, life, disability, and flexible spending benefits.
• Retirement and savings plan with company contributions.
• Annual bonus program and stock-based long-term incentives.
• Paid time off and career development opportunities.