Specialist Manufacturing - Upstream DS (Biotech)

Location: On-site in Thousand Oaks, California, United States. Requires work in a clean room environment and availability for variable shifts, including weekends and holidays.

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

• 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 production issues, execute function tests and experiments, and optimize manufacturing processes.
• Write protocols, reports, SOPs, forms, and user requirements for validation, commissioning, qualification, and change management.
• Own quality records including CCMS, CAPA, and CAPA-EV, and present technical findings to inspectors and colleagues.
• Perform hands-on work on the plant floor, analyze data, document operations, and support equipment and process readiness.

Requirements

• Doctorate degree; or a master’s degree with 2 years of manufacturing or operations experience; or a bachelor’s degree with 4 years; or an associate degree with 8 years; or a high school diploma/GED with 10 years.
• Three or more years of experience in drug substance GMP technical support, GMP manufacturing, engineering, process development, or an equivalent area.
• Technical knowledge of drug substance processing, GMP compliance, single-use technologies, and related disciplines.
• Experience leading projects and cross-functional teams, with strong troubleshooting, communication, technical writing, and data analysis skills.
• Ability to work on-site, follow GMP documents and safety procedures, and wear full clean-room gowning and required protective equipment.
• Proficiency with Smartsheet, Excel, TrackWise, Visio, PI, SAP, and Spotfire.

Culture & Benefits

• Collaborative, innovative, science-based work environment focused on serving patients.
• Health, dental, vision, life, disability, and flexible spending benefits for eligible employees and dependents.
• Retirement and savings plan with company contributions, stock-based long-term incentives, and an annual bonus program.
• Paid time-off plans and career development opportunities.
• Sponsorship for this role is not guaranteed.