Process Development Sr Principal Scientist (Biotechnology)

Location: Thousand Oaks, California, United States; domestic and international travel up to 10%.

Company

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

What you will do

• Lead drug product commercialization teams responsible for laboratory studies in formulation, product design, and process development.
• Support clinical and commercial fill/finish operations through process capability analysis, troubleshooting, root cause analysis, and product impact assessments.
• Drive continuous improvement through process engineering, technological innovation, historical data, large-scale data analysis, and statistical methods.
• Lead global cross-functional teams and influence technical decisions in a matrixed environment.
• Author and review technical protocols, reports, regulatory submissions, and responses to regulatory questions.
• Deliver progress reports and presentations covering program status, risks, and functional needs.

Requirements

• Advanced degree in Pharmaceutics, Biotechnology, Engineering, Material Science, or a related field.
• At least 5 years of post-doctoral or industry experience in pharmaceuticals, biotechnology, or a related field.
• Experience developing liquid, lyophilized, and/or oral solid dosage drug products and parenteral biologics.
• Experience with process characterization, scale-up, commercial manufacturing, equipment implementation, technical transfers, and statistical process control.
• Knowledge of combination product regulations, cGMPs, ICH guidelines, pre-approval inspections, and audits.
• Experience with protein stability, freezing and drying impacts, aseptic processing, investigations, regulatory filings, and design and analysis of experiments.

Culture & Benefits

• Comprehensive employee benefits including medical, dental, vision, life, disability, and flexible spending plans.
• Retirement and savings plan with company contributions.
• Annual bonus program and stock-based long-term incentives.
• Award-winning time-off plans and flexible work models where applicable.
• Collaborative, inclusive, science-based environment focused on improving patient outcomes.