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 the company’s competitive edge in the biologics industry. The position develops and optimizes biologics production processes, scales processes from laboratory to pilot and production scales, and addresses process development and optimization issues. It also identifies and implements process improvements to reduce costs, increase yield, improve productivity, and enhance product quality. The Senior Scientist applies engineering principles to biologics production equipment and processes, collaborates on process control systems, ensures compliance with applicable standards and regulations, and provides technical expertise on biologics to cross-functional teams. The role requires a master’s degree in a related scientific or engineering field and at least four years of experience in biologics R&D, process development, and process improvement. 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.
  • Experience conducting experiments, analyzing data, and making data-driven decisions.
  • Strong 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 the production of biologic products.
  • Scale up 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 opportunities for process improvement 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 current 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.
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