Senior Scientist II, Downstream Purification, Toxins

Company Description

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

The Product Development, Science and Technology (PDS&T), Toxins group supports manufacturing, process characterization, process validation, regulatory submission, and continuous improvement for late-stage and commercial manufacturing of biological toxin products in AbbVie. We have an exciting opportunity for a Senior Scientist II, Downstream Purification position based in Irvine, CA. The scientist will apply scientific, engineering principles, modeling and statistical process design/analysis to develop robust toxin 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.

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 mechanistic modeling to build digital platforms for data visualization, analysis and prediction.
• 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 Toxins group in CMC program teams. Interact effectively with diverse groups within function and maintain strong working relationships with internal, global, and external collaborators.

Qualifications

• BS, MS, or PhD in Chemical Engineering, Biochemistry, Chemistry or closely related field with typically 12+ (BS), 10+ (MS) or 4+ (PhD) years of postdoc or industry related experience.
• Experience in areas of bioprocess development, process characterization, modeling, validation, regulatory submissions, and manufacturing support.
• Demonstrate independence leadership and enterprise mindset
• 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

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This ran