New Product Introduction Lead (Biotechnology Manufacturing)

Location: On site in Thousand Oaks, California, United States

Salary: $86,048.05–$116,417.95 per year

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 new product introduction and technology transfer planning for the Thousand Oaks drug product manufacturing facility.
• Develop, maintain, and implement NPI project plans covering scope, schedules, risks, and milestones.
• Coordinate matrixed teams across manufacturing, process development, supply chain, quality, and facilities and engineering.
• Resolve issues through root cause analysis and communicate recommendations and customer concerns to management.
• Own GMP-compliant change controls in TrackWise and NPI records in the Veeva CDOCS system.
• Lead cross-functional meetings, Gemba walks, lessons-learned activities, process improvements, and operational metrics reporting.

Requirements

• Master’s degree in engineering, biology, chemistry, or a life science field; or a relevant bachelor’s degree plus 2 years of biotechnology operations experience.
• Alternative qualification paths include an associate’s degree plus 4 years of biotechnology operations experience, or a high school diploma/GED plus 6 years of biotechnology operations experience.
• Knowledge of drug product technical manufacturing processes, manufacturing operations, scientific methods, regulatory compliance, and quantitative troubleshooting.
• Experience with drug product formulation and vial or syringe filling operations in a GMP environment is preferred.
• Strong organization, technical writing, communication, project management, flexibility, and ability to work independently in a fast-paced environment.

Culture & Benefits

• Collaborative, innovative, science-based work environment focused on serving patients.
• Health, dental, vision, life, disability, and flexible spending benefits.
• Retirement and savings plan with company contributions.
• Discretionary annual bonus and stock-based long-term incentives.
• Paid time off and career development opportunities.