Section Manager, Technical
AbbVie's mission is to discover and deliver innovative medicines 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: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .
- Manage directly and through assigned staff the technical support (product and process expertise) of manufacturing operations for marketed products. This includes a range of activities, from day-to-day manufacturing problem solving, and excipient changes, to maintaining regulatory compliance and quality standards.
- Provide feedback on quality issues that are process and product related (e.g., product complaints from the market and stability investigations),
- Manage technology transfer from R&D or Third Party development organizations to or from facilities.
- Manage and execute major significant product investigations. Management and execution can include project reports, investigations and nonconformances. Make scientific recommendations with the support of management as to the acceptability and quality of affected product lots.
- Identify and implement process changes to improve product quality and/or reduce processing cost in the manufacturing of currently marketed products. Prepare and review scientific reports describing and supporting process changes and improvements for potential submission to governmental regulatory agencies.
- Be an active member of the plant and division level project/product improvement teams.
- Provide product and process expertise in the execution of plant projects (for example, installation of new manufacturing equipment).
- Responsible for managing activities of subordinates on his/her staff with respect to performance management, development plans, promotion recommendations and salary management.
- Participate as a member of the plant Validation Review Board (VRB) by providing technical expertise.Serve as the plant Technical Operations interface for the transition of R&D projects into the manufacturing facility.
- BS degree in a scientific or technical field preferably in life sciences, pharmacy or engineering.
- Knowledge of applicable regulations and standards affecting Pharmaceutical Products (e.g. CFR 210/211, cGMP)
- The following combinations of education and experience are required: BS and 8+ years of experience; or MS and 6+ years of experience; or PhD and 4+ years of experience.
- Must have 4+ years of experience in formulation and/or analytical chemistry with experience in technical support activities desirable. Must be recognized as a credible opinion on CMC issues. Must have a record of demonstrated successful development or commercialization of marketed products.
Significant Work Activities
Yes, 15 % of the Time
Job Level Code
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic.