Specialist Manufacturing - Upstream DS (Biotech Manufacturing)

Location: On-site in Thousand Oaks, California, United States. The role requires work in a clean room and availability for day, swing, graveyard, weekend, and holiday shifts according to the production schedule.

Company

hirify.global presents an opportunity with Amgen, a biotechnology company developing and manufacturing medicines for serious illnesses across oncology, inflammation, general medicine, and rare disease.

What you will do

• Support drug substance upstream manufacturing as a process owner and subject-matter expert.
• Lead cross-functional projects involving new products, technologies, equipment, process changes, and continual improvement.
• Troubleshoot manufacturing issues, execute function tests and experiments, and optimize processes using plant-floor data.
• Write protocols, reports, SOPs, forms, user requirements, and other GMP documentation for validation, commissioning, qualification, and change management.
• Own quality records including CCMS, CAPA, and CAPA-EV, and present technical information to inspectors, auditors, and leadership.
• Mentor junior staff and support operational readiness for new technologies, equipment, and processes.

Requirements

• Doctorate degree; or a master's degree plus 2 years of manufacturing or operations experience; or a bachelor's degree plus 4 years; or an associate's degree plus 8 years; or a high school diploma/GED plus 10 years.
• Experience in drug substance GMP technical support, GMP manufacturing, engineering, process development, or an equivalent area; 3 or more years is preferred.
• Knowledge of drug substance processing, GMP compliance, single-use technologies, technical troubleshooting, and process improvement.
• Experience leading projects and cross-functional teams, with strong technical writing, presentation, data analysis, and problem-solving skills.
• Proficiency in Smartsheet, Excel, TrackWise, Visio, PI, SAP, and Spotfire is preferred.
• Must be able to work on-site in a clean room, follow GMP procedures, wear required protective equipment, and work variable shifts.

Culture & Benefits

• Collaborative, innovative, science-based work environment focused on serving patients.
• Comprehensive 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.
• Award-winning time-off plans and career development opportunities.
• Sponsorship is not guaranteed for this role.