Senior Scientist I, Downstream Purification, PDS&T

AbbVie • Irvine, CA

15d

About The Position

The Product Development, Science and Technology (PDS&T) group supports manufacturing, process characterization, process validation, regulatory submission, and continuous improvement for late-stage and commercial manufacturing of biological products in AbbVie. We have an exciting opportunity for a Senior Scientist I, Downstream Purification position based in Irvine, CA. The scientist will apply scientific, engineering principles, modeling and statistical process design/analysis to develop robust manufacturing process hands-on. The candidate must have in-depth knowledge and hands-on experience including but not limited to bioprocess development, scale down model qualification, protein characterization, etc. Excellent communication skills and the ability to work within a multi-disciplinary and cross-functional teamwork environment are essential.

Requirements

• 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 related experience.
• Experience in areas of 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 are required.
• Must have a “results-oriented” work ethic and a positive “can-do” attitude with a strong sense of urgency and self-motivated desire to achieve.
• 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

Responsibilities

• Support late stage and commercial biologics manufacturing, technology transfer, process validation, investigations, troubleshooting, scale-up, and continuous improvement.
• Develop protein recovery and purification process that utilizes clarification, chromatography, and membrane filtration technologies.
• Provide deeper understanding of process performance using appropriate experimental and modeling tools.
• Design, execute and analyze experiments using a robust scale-down model for process characterization and continued process improvement of commercial biologics products.
• Leverage data science and advanced modeling to build digital platforms for data visualization and analysis.
• Support/ lead new product introduction into the manufacturing area, ensuring successful tech transfer, scale up and validation for the product.
• Support product investigations and non-conformances.
• Identify root causes and make scientific recommendations as to the acceptability and quality of affected product lots.
• Author and review relevant CMC sections of submissions and support agency inspections, inquiries and audits.
• Represent the PDS&T group in CMC program teams.
• Interact effectively with diverse groups within function and maintain strong working relationships with internal, global, and external collaborators.

Benefits

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our short-term incentive programs.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior