Senior Scientist I, Downstream Purification, PDS&T

Role Summary

The Senior Scientist I, Downstream Purification, PDS&T is based in Irvine, CA. The role applies scientific and engineering principles, modeling and statistical process design/analysis to develop robust manufacturing processes hands-on. The candidate should have in-depth knowledge and hands-on experience in bioprocess development, scale-down model qualification, protein characterization, and related areas, with excellent communication skills for cross-functional collaboration.

Responsibilities

• Support late stage and commercial biologics manufacturing, technology transfer, process validation, investigations, troubleshooting, scale-up, and continuous improvement.
• Develop protein recovery and purification processes utilizing clarification, chromatography, and membrane filtration technologies; quantify process performance using experimental and modeling tools.
• Design, execute, and analyze experiments using a scale-down model for process characterization and continued improvement of commercial biologics products.
• Leverage data science and advanced modeling to build digital platforms for data visualization and analysis.
• Support or lead new product introductions into manufacturing, ensuring successful tech transfer, scale-up, and validation.
• Support product investigations and non-conformances; identify root causes and provide scientific recommendations on product lot quality.
• Author and review relevant CMC sections of submissions and support agency inspections, inquiries, and audits.
• Represent the PDS&T group in CMC program teams; collaborate effectively with diverse internal and external partners.

Qualifications

• BS, MS, or PhD in Chemical Engineering, Biochemistry, Chemistry or closely related field with typically 10+ (BS), 8+ (MS) or 0+ (PhD) years of postdoc or industry experience.
• Experience in bioprocess development, process characterization, modeling, validation, regulatory submissions, and manufacturing support.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Excellent communication, writing and presentation skills.
• Results-oriented work ethic with a positive, proactive attitude and sense of urgency.
• Demonstrated knowledge of GMP and experience providing technical support in a GMP manufacturing environment.
• Demonstrated ability to collaborate effectively in a dynamic, cross-functional matrix environment.

Education

• BS, MS, or PhD in Chemical Engineering, Biochemistry, Chemistry or closely related field as specified above.