Specialist, Manufacturing Production Process Owner (Biotech Manufacturing)

Location: Thousand Oaks, California, United States; onsite manufacturing site

Company

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

What you will do

• Support investigations and resolution of major manufacturing deviations, including root cause analyses and human performance evaluations.
• Develop, implement, and monitor corrective and preventive actions.
• Create, revise, review, and approve controlled manufacturing documents in the electronic document management system.
• Support implementation of new processes, equipment, SOPs, batch records, training, validation, and automation configurations.
• Analyze manufacturing data with Enterprise Data Lake and Spotfire to improve yield, reliability, and GMP compliance.
• Support process validation, change control, process monitoring, and continuous improvement initiatives in Drug Product operations.

Requirements

• Doctorate degree; or a master’s degree and 2 years of manufacturing experience; or a bachelor’s degree and 4 years of manufacturing experience; or an associate degree and 8 years of manufacturing experience; or a high school diploma/GED and 10 years of manufacturing experience.
• Experience in aseptic Drug Product or biologics manufacturing.
• Experience with root cause analysis and major deviations.
• Knowledge of process validation, deviation management, change control, GMP, and regulatory compliance.
• Strong analytical, problem-solving, project coordination, communication, and cross-functional collaboration skills.
• Experience with data visualization and analytics tools such as Spotfire, JMP, and Excel.

Culture & Benefits

• Collaborative, innovative, and science-based work environment.
• Health, dental, vision, life, disability, and flexible spending benefits for eligible employees and dependents.
• Retirement and savings plan with company contributions.
• Discretionary annual bonus program and stock-based long-term incentives.
• Paid time-off plans and career development opportunities.
• Flexible work models where applicable to the role.

Hiring process

• Applications are accepted until a sufficient number of candidates are received or a candidate is selected.
• Sponsorship for the role is not guaranteed.