Associate Director, Commercial Drug Products & Life Cycle Management

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 illnesses across oncology, inflammation, general medicine, and rare disease.

What you will do

• Lead commercial drug product programs as the technical accountable leader for formulation, aseptic process design and validation, combination products, lifecycle changes, and regulatory activities.
• Plan, execute, and document laboratory studies supporting formulation, drug product process development, commercialization, and lifecycle management.
• Lead and coach scientists working on late-stage process development and technology transfer.
• Support clinical and commercial fill-finish operations through process capability analysis, troubleshooting, root cause analysis, and product impact assessments.
• Drive process improvement through technological innovation, first-principles process engineering, advanced information systems, large-scale data analysis, and statistical methods.
• Prepare technical protocols, reports, regulatory submissions, responses to regulatory questions, and management progress presentations while coordinating global cross-functional teams.

Requirements

• Doctorate with 3 years, master’s degree with 7 years, bachelor’s degree with 9 years, associate degree with 12 years, or high school diploma/GED with 14 years of engineering or science experience.
• At least 3 years of direct people management or leadership experience involving teams, projects, programs, or resource allocation.
• Experience in pharmaceutical or biopharmaceutical development, formulation, process development, commercialization, and lifecycle management.
• Hands-on knowledge of liquid, lyophilized, and/or oral solid dosage products, process transfers, validation, control strategies, regulatory submissions, and commercial-site support.
• Experience with aseptic processing, cGMPs, ICH guidelines, single-use manufacturing equipment, process characterization, statistical process control, and design of experiments.
• Ability to lead global cross-functional teams and communicate effectively in a highly 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.
• Knowledge of protein physical and chemical stability, including the effects of freezing and drying on product quality.

Culture & Benefits

• Collaborative, innovative, science-based work environment with global cross-functional collaboration.
• Health, dental, vision, life, disability, and flexible spending benefits.
• Retirement and savings plan with company contributions, stock-based long-term incentives, and an annual bonus program.
• Paid time-off programs, work-life balance support, and career development opportunities.
• Flexible work models may be available where applicable; sponsorship is not guaranteed.