The S&T Toxins group within Operations Science & Technology - Biologics organization supports manufacturing, process validation, regulatory submission, and continuous improvement for late-stage and commercial manufacturing of biological toxins products in AbbVie. We have an exciting opportunity for a Senior Scientist I/II position based in Irvine, CA. The scientist will apply scientific, engineering principles and statistical process design/analysis to develop robust toxin manufacturing process hands-on. The candidate must have in-depth knowledge and 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.
§ Support late stage and commercial biologics manufacturing, technology transfer, process validation, investigations, troubleshooting, scale-up, and continuous improvement.
§ Design, execute and analyze experiments using a robust scale-down model for continued process improvement of commercial biologics products.
§ Identify and implement technical innovations to improve product quality, improve yield, qualify new material suppliers, reduce cost and/or enhance the intellectual property landscape.
§ Support CMC life cycle management and post-approval continued process validation for commercial DS.
§ 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 S&T Toxins group in CMC program teams. Interacts effectively with diverse groups within function and maintains strong working relationships with internal, global, and external collaborators.
§ Responsible for compliance with applicable Corporate and Divisional policies and procedures.
- Sr Scientist I: 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.
- Sr Scientist II: 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, 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.
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 range may be modified in the future.
· 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.
· This job is eligible to participate in our long-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.