Senior Scientist (Wednesday - Sunday)

Shift: Wednesday - Sunday

Location: Irvine, CA

Key Responsibilities

Operational & Manufacturing Leadership

• Support the BI Lab in managing day‑to‑day operations related to manufacturing, materials, facilities, scheduling, engineering, and maintenance to ensure smooth, continuous, cost‑effective, and controlled production

• Plan, prepare, issue, and control production schedules and material requirements to ensure timely availability of approved materials aligned with production forecasts and inventory goals

• Serve as shift or operational lead as required to maintain production execution, area readiness, and GMP compliance

Production Support

• Perform hands‑on production and testing activities as needed to support execution, training, troubleshooting, or elevated business demand

• Apply scientific techniques to culture and test spores used in the biological indicator manufacturing process

• Prepare, review, and technically assess batch records in accordance with cGDP

Technical Leadership & Troubleshooting

• Lead and support complex product deviations, process excursions, and production issues using scientific, technical, and statistical diagnostic methods

• Apply standard scientific principles, theories, and concepts to evaluate process performance and implement corrective and preventive actions

• Provide developmental and technical support for both new and existing products

Process Development, Optimization & Improvement

• Identify opportunities to improve existing processes, systems, and equipment to increase efficiency, improve quality, and reduce cost

• Design, execute, and interpret experiments to optimize manufacturing processes and reduce variability

• Lead or co‑lead Kaizens and other continuous improvement initiatives

• Monitor process performance metrics and ensure sustained improvements through data‑driven decision making

Education and Experience Requirements

• Bachelor’s Degree in Biology, Microbiology, Biochemistry, Chemical Engineering, or a related scientific discipline required

• Master’s Degree preferred

• 4–8+ years of experience in a regulated biologics or medical device manufacturing environment

• Demonstrated experience leading technical projects, investigations, or cross‑functional initiatives

• Experience with process development, process improvement, and operational support in manufacturing environments

Required Knowledge & Skills

• Advanced knowledge of cGMP and cGDP requirements

• Strong experience working in FDA‑regulated environments and Medical Device manufacturing

• Expertise in aseptic processing and biologics manufacturing

• Ability to design experiments, analyze data, and interpret results

• Strong written and verbal communication skills

• Proficiency with Excel and data analysis tools

• Preferred Qualifications

• Knowledge of SAP inventory management systems

• Experience with statistical tools (e.g., Minitab)

• Yellow Belt or Green Belt certification (Black Belt a plus)

• Train‑the‑Trainer or Training Within Industry (TWI) experience

• Knowledge of process control systems and automation

Work Environment & Physical Requirements

• Domestic travel up to approximately 10%

• On‑call or weekend support may be required

• Ability to lift 31–50 lbs

• Ability to wear required PPE

• Ability to work in a manufacturing laboratory environment

About Company

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