Senior Scientist (Wednesday - Sunday)

Fortive•Irvine, CA

7h•Onsite

About The Position

The Senior Scientist will 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. This role involves planning, preparing, issuing, and controlling production schedules and material requirements. The Senior Scientist will also perform hands-on production and testing activities, apply scientific techniques to culture and test spores, and prepare, review, and technically assess batch records. Additionally, the position requires leading and supporting complex product deviations, process excursions, and production issues, applying standard scientific principles to evaluate process performance, and providing developmental and technical support for products. The role also focuses on identifying opportunities to improve existing processes, designing and interpreting experiments for process optimization, leading continuous improvement initiatives, and monitoring process performance metrics.

Requirements

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

Nice To Haves

Master’s Degree preferred.
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.

Responsibilities

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.
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.
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.
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.