Senior Scientist (Wednesday Saturday)

Shift: Wednesday - Saturday

Location: Irvine CA

Key Responsibilities

Operational & Manufacturing Leadership

• Support the BI Lab in managing daytoday operations related to manufacturing materials facilities scheduling engineering and maintenance to ensure smooth continuous costeffective 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 handson 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 colead Kaizens and other continuous improvement initiatives

• Monitor process performance metrics and ensure sustained improvements through datadriven decision making

Education and Experience Requirements

• Bachelors Degree in Biology Microbiology Biochemistry Chemical Engineering or a related scientific discipline required

• Masters Degree preferred

• 48 years of experience in a regulated biologics or medical device manufacturing environment

• Demonstrated experience leading technical projects investigations or crossfunctional 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 FDAregulated 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)

• TraintheTrainer or Training Within Industry (TWI) experience

• Knowledge of process control systems and automation

Work Environment & Physical Requirements

• Domestic travel up to approximately 10%

• Oncall or weekend support may be required

• Ability to lift 3150 lbs

• Ability to wear required PPE

• Ability to work in a manufacturing laboratory environment