Scientist/Senior Engineer Commercial Drug Product (Biotechnology)

Location: Thousand Oaks, California, United States

Company

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

What you will do

• Lead assigned commercial and late-stage drug product SKUs across formulation, fill/finish, presentation, commercialization, and lifecycle management.
• Support technology transfers through facility-fit assessments, process gap and risk analyses, process characterization, technical documentation, and on-site manufacturing activities.
• Provide technical leadership for parenteral operations including formulation, mixing, sterile filtration, filling, capping, lyophilization, and visual inspection.
• Plan and execute laboratory, offline, and on-site studies covering scale-up, process robustness, process monitoring, and lifecycle management.
• Support troubleshooting, root cause analysis, non-conformance investigations, corrective and preventive actions, process capability analysis, and product impact assessments.
• Collaborate with Process Development, Manufacturing, Quality, Regulatory, Engineering, Supply Chain, Attribute Sciences, and manufacturing sites in a global matrixed environment.

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.
• Master’s or Ph.D. in Chemical Engineering, Biomedical Engineering, Pharmaceutical Sciences, Pharmaceutics, Chemistry, Biochemistry, Biotechnology, Materials Science, or a related technical discipline.
• At least 3 years of experience in drug product process development, process engineering, commercialization, manufacturing sciences, or lifecycle management within the pharmaceutical or biotechnology industry.
• Experience with parenteral drug product development and manufacturing, including liquid or lyophilized products, fill/finish operations, aseptic processing, cGMPs, ICH guidelines, and GMP documentation.
• Experience with process characterization, scale-up, technology transfer, process validation support, design of experiments, statistical process control, risk assessment, and commercial manufacturing support.
• Ability to analyze complex datasets, communicate technical recommendations, influence cross-functional stakeholders, and travel domestically and internationally as required.

Nice to have

• Experience serving as a technical, SKU, process, or commercialization lead for late-stage or commercial drug product programs.
• Familiarity with AI-enabled tools, advanced analytics, process monitoring, modeling, and digital systems for process characterization and knowledge management.

Culture & Benefits

• Comprehensive employee benefits including medical, dental, vision, life, disability, and flexible spending plans.
• Retirement and savings plan with company contributions and stock-based long-term incentives.
• Discretionary annual bonus program and award-winning time-off plans.
• Flexible work models where applicable to the work location type.
• Collaborative, inclusive, science-based environment with opportunities for professional development.