Senior Scientist

Fortive•Irvine, CA

About The Position

The Senior Scientist at Advanced Sterilization Products designs, conducts, and analyzes experiments to optimize processes, improve efficiency, and ensure high-quality biologic products. The role works collaboratively with cross-functional teams to drive innovation and maintain competitiveness in the biologics industry. The position develops and optimizes biologic production processes; scales processes from laboratory to pilot and production scales; troubleshoots process issues; and designs and executes experiments for new and existing products. It analyzes experimental data, recommends further research or process adjustments, and collaborates with R&D teams to implement new technologies and methodologies. The role also identifies and implements process improvements, monitors performance metrics, applies engineering principles to equipment and process design, supports process control systems, and ensures compliance with industry standards and regulatory requirements. The Senior Scientist maintains expertise in biologics processes—including cell culture, fermentation, purification, and formulation—keeps current with industry and regulatory developments, and provides technical guidance to cross-functional teams. Occasional travel may be required for conferences, training, or meetings with external partners.

Requirements

Master's degree in Biochemistry, Molecular Biology, Chemical Engineering, or a related field.
At least 4 years of experience in biologics R&D, process development, and process improvement.
Strong background in biologic production processes, including cell culture, fermentation, purification, and formulation.
Proven experience conducting experiments, analyzing data, and making data-driven decisions.
Excellent problem-solving skills and ability to troubleshoot complex process issues.
Strong project management skills and ability to manage multiple projects simultaneously.
Excellent communication and collaboration skills, with ability to work effectively in cross-functional teams.
Knowledge of regulatory requirements and industry standards for biologics production.
May require occasional travel to conferences, training, or meetings with external partners.

Nice To Haves

Knowledge of process control systems and automation.
Experience with statistical analysis.

Responsibilities

Develop and optimize processes for producing biologic products.
Scale processes from laboratory to pilot and production scales.
Troubleshoot and resolve process development and optimization issues.
Design and execute experiments to develop new biologic products and improve existing products.
Analyze experimental data, interpret results, and recommend further research or process adjustments.
Collaborate with R&D teams to innovate and implement new technologies and methodologies.
Identify process improvement opportunities and develop strategies to enhance efficiency and product quality.
Implement process improvements to reduce costs, increase yield, and improve productivity.
Monitor and analyze process performance metrics to support continuous improvement.
Apply engineering principles to design and optimize equipment and processes for biologic production.
Work with engineering teams to design and implement process control systems.
Ensure compliance with industry standards and regulatory requirements.
Maintain expertise in biologics, including cell culture, fermentation, purification, and formulation.
Stay current with industry trends, advancements, and regulatory changes in biologics.
Provide technical expertise and guidance to cross-functional teams.