Senior Scientist I, Upstream Process Full-time NEW

Senior Scientist I, Upstream Toxin Process

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.

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 I, Upstream Toxin Process 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 and optimize upstream process conditions, including cell bank generation, fermentation culture and harvest strategies, to improve productivity, product quality, and process robustness.
• Design, execute and analyze experiments using a robust scale-down model for upstream process characterization and continuous improvement of commercial biologics products.
• Provide microbiology support for new product introduction, including contamination risk assessment, environmental monitoring strategy support, and coordination of microbiological activities as needed for manufacturing readiness.
• Evaluate system biology tool to enhance understanding on cellular metabolism.
• Leverage data science and advanced modeling to build digital platforms for data visualization and analysis.
• 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 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.
• Hands-on experience with upstream process development, microbiology, scale-down model development/qualification, and upstream process optimization.
• 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

Pay Range: $ 96500 – 183500 USD