Quick overview
SeniorityMid Senior
Employment typeFull Time
Work modeOn Site
LocationIrvine, United States
ComplianceContinuous ImprovementProcess ImprovementProject Management
Job description
The Senior Scientist at Advanced Sterilization Products involves designing, conducting, and analyzing experiments to optimize processes, improve efficiency, and ensure high-quality biologic products. The successful candidate will work collaboratively with cross-functional teams to drive innovation and maintain our competitive edge in the biologics industry.
Responsibilities
Process Development:
- Develop and optimize processes for the production of biologic products.
- Scale-up processes from laboratory to pilot and production scales.
- Troubleshoot and resolve issues related to process development and optimization.
- Design and execute experiments to develop new biologic products and improve existing ones.
- Analyze experimental data, interpret results, and make recommendations for further research or process adjustments.
- Collaborate with R&D teams to innovate and implement new technologies and methodologies.
Process Improvement:
- Identify areas for process improvement and develop strategies to enhance efficiency and product quality
- Implement process improvements to reduce costs, increase yield, and improve overall productivity.
- Monitor and analyze process performance metrics to ensure continuous improvement.
Engineering:
- 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.
Biologics Expertise:
- Maintain a deep understanding of biologics, including cell culture, fermentation, purification, and formulation processes.
- Stay current with industry trends, advancements, and regulatory changes in biologics.
- Provide technical expertise and guidance to cross-functional teams.
Qualifications
Required:
- Master's degree in Biochemistry, Molecular Biology, Chemical Engineering, or a related field.
- 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 in conducting experiments, analyzing data, and making data-driven decisions.
- Excellent problem-solving skills and the ability to troubleshoot complex process issues.
- Strong project management skills and the ability to manage multiple projects simultaneously.
- Excellent communication and collaboration skills, with the ability to work effectively in cross-functional teams.
- Knowledge of regulatory requirements and industry standards for biologics production.
- May require occasional travel to attend conferences, training, or meetings with external partners.
Preferred:
- Knowledge of process control systems and automation.
- Experience with statistical analysis
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