Senior Scientist I, Upstream Process
About The Position
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.
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.
- 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
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.
Benefits
- paid time off (vacation, holidays, sick)
- medical/dental/vision insurance
- 401(k)
- short-term incentive programs
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Senior
