Associate Director Process Development (Pharmaceutical)

Location: US - California - Thousand Oaks; ability to travel domestically and internationally up to 10% of the time.

Expected annual salary: $164,021.95–$221,912.05 USD.

Company

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

What you will do

• Lead commercial drug product programs as the technical accountability owner for formulation, aseptic process design and validation, combination product development, process improvements, lifecycle changes, and regulatory submissions.
• Plan, execute, and document laboratory studies supporting commercialization and lifecycle management of parenteral and oral solid dosage products.
• Lead and coach scientists focused on late-stage drug product process development and technology transfer.
• Support clinical and commercial fill/finish operations through process capability analysis, troubleshooting, root cause analysis, and product impact assessments.
• Lead global cross-functional teams, drive continuous improvement, and prepare technical protocols, reports, regulatory submissions, and responses to regulatory questions.
• Use advanced information systems, historical data, large-scale datasets, and statistical analysis to improve drug product design.

Requirements

• Doctorate with 3 years of engineering or science experience; or master’s degree with 7 years; bachelor’s degree with 9 years; associate’s degree with 12 years; or high school diploma/GED with 14 years.
• At least 3 years of direct people management or leadership experience directing teams, projects, programs, or resource allocation.
• Experience in pharmaceutical development, formulation, process development, commercialization, and lifecycle management.
• Knowledge of process transfers, validation support, regulatory submissions, regulatory responses, cGMPs, ICH guidelines, and aseptic processing.
• Experience with liquid, lyophilized, and/or oral solid dosage products, single-use manufacturing equipment, process characterization, equipment implementation, and statistical design and analysis of experiments.
• Strong problem-solving, communication, rapid learning, and cross-functional leadership skills in a matrixed environment.

Nice to have

• PhD in biotechnology, pharmaceutical sciences, pharmaceutical chemistry, chemical engineering, biomedical engineering, or a related scientific field.
• 8+ years of pharmaceutical development and management experience.
• Experience with protein stability, freezing and drying effects, statistical process control, and technical transfers to global manufacturing sites.

Culture & Benefits

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