Senior Engineer - Drug Substance Technology & Engineering

Location: Thousand Oaks, California, United States

Salary: USD 115,494.60–156,257.40 per year

Company

hirify.global is a biotechnology company developing, manufacturing, and delivering medicines for serious illnesses.

What you will do

• Provide engineering and technical support for cGMP clinical and commercial downstream purification processes, including harvest and clarification, chromatography, viral filtration, UF/DF, and sterile filtration.
• Lead technology transfer, process and facility-fit assessments, risk analyses, manufacturing readiness activities, and process documentation.
• Support manufacturing execution through on-floor technical escalation, process monitoring, troubleshooting, investigations, and process improvement.
• Apply engineering principles, statistical analysis, and design of experiments to evaluate process performance, identify risks, and resolve technical issues.
• Collaborate with Manufacturing, Quality, Process Development, Validation, Regulatory, Supply Chain, Facilities and Engineering, and network drug substance teams.
• Manage, mentor, and develop downstream process engineers while providing technical leadership across cross-functional projects.

Requirements

• Doctorate degree; or a master’s degree with 2 years of engineering experience; or a bachelor’s degree with 4 years; or an associate’s degree with 8 years; or a high school diploma/GED with 10 years of engineering experience.
• 5+ years of experience in downstream purification and engineering support for pharmaceutical processes and product development.
• 2+ years of direct people management or leadership experience leading teams, projects, programs, or resource allocation.
• Expertise in downstream purification, commercial biologics manufacturing, process development, scale-up, technology transfer, process validation, PPQ, continued process verification, and manufacturing execution.
• Strong understanding of cGMP, regulatory, safety, and quality requirements, including regulatory filings, inspections, and product lifecycle activities.
• Ability to use engineering principles, statistical analysis, process data, process monitoring, modeling, Quality by Design, and data visualization to troubleshoot and improve biological processes.

Nice to have

• Experience with Process Analytical Technology and advanced biological process modeling or visualization tools.
• Experience evaluating scale-up considerations, technology transfer risks, and facility-fit requirements.

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.
• Discretionary annual bonus, stock-based long-term incentives, and paid time-off plans.
• Career development opportunities and flexible work models where applicable.
• Limited domestic and international travel may be required.

Hiring process

• Applications are accepted until a sufficient number of candidates is received or a candidate is selected.
• Visa sponsorship is not guaranteed.