Scientist/Senior Engineer – Commercial Drug Product (Biotech)

Location: Thousand Oaks, California, United States

Annual salary: $111,940.75–$151,449.25 USD

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

• Lead assigned commercial or late-stage drug product SKUs across formulation, fill/finish, presentation, and lifecycle management.
• Lead or support technology transfers, facility-fit assessments, process gap analyses, risk assessments, process characterization, and on-site manufacturing activities.
• Provide technical leadership for parenteral operations including formulation, mixing, sterile filtration, filling, capping, lyophilization, and visual inspection.
• Design, execute, and document laboratory, offline, and on-site studies for process development, scale-up, robustness, and lifecycle management.
• Support manufacturing through process capability analysis, troubleshooting, root cause analysis, non-conformance investigations, corrective and preventive actions, and product impact assessments.
• Author technical protocols, study reports, transfer documents, regulatory submission sections, and lifecycle management documentation while aligning global cross-functional stakeholders.

Requirements

• Doctorate degree, or a master’s degree with 4 years of relevant experience, or a bachelor’s degree with 6 years of relevant experience.
• 3+ years of experience in drug product process development, process engineering, commercialization, manufacturing sciences, or lifecycle management in the pharmaceutical or biotechnology industry.
• Experience with parenteral drug product development and manufacturing, including liquid or lyophilized presentations and fill/finish operations.
• Experience with process characterization, scale-up, technology transfer, process validation support, commercial manufacturing, and aseptic processing.
• Knowledge of cGMPs, ICH guidelines, regulatory filings, non-conformance investigations, statistical process control, design of experiments, and risk assessment.
• Ability to analyze complex datasets, use statistical or digital tools, communicate technical information, influence cross-functional teams, and travel domestically and internationally as required.

Nice to have

• M.S. or Ph.D. in chemical engineering, biomedical engineering, pharmaceutical sciences, pharmaceutics, chemistry, biochemistry, biotechnology, material science, or a related technical discipline.
• Experience with AI-enabled tools or advanced analytics for process characterization, process monitoring, knowledge management, and data-driven decision-making.

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, stock-based long-term incentives, and award-winning time-off plans.
• Career development opportunities and flexible work models where applicable.