Senior Scientist, Engineering II

Company Description

About Abb Vie
Abb Vie'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 Abb Vie, please visit us at  Follow @abbvie on Linked In, Facebook, Instagram, X and You Tube.

Purpose
Lead late-stage development, scale-up, validation, and commercialization activities for oral solid dosage products. Apply scientific and engineering principles to develop robust manufacturing processes, establish control strategies, execute technology transfers, and support regulatory submissions. Serve as a technical leader within cross-functional teams to ensure successful product commercialization and lifecycle management.

• Demonstrate the ability to resolve key project hurdles and assumptions by effectively utilizing available information and technical expertise.
• Lead scale-up of oral solid dosage processes from pilot to commercial manufacturing.
• Develop and execute technology transfer strategies for internal and external manufacturing sites.
• Apply experimental design, mechanistic understanding, and modeling tools to support process development and scale-up.
• Establish scientifically sound process control strategies and critical process parameters.
• Lead process characterization, PPQ, and validation activities to support product commercialization.
• Author and review regulatory CMC documentation, including CTD Module 3.2.P.2.3 content.
• Proactively seek out new information in the literature and incorporate this into individual project(s) as well as the overall program.
• Collaborate effectively with Manufacturing, Quality, Regulatory Affairs, and Technical Operations to achieve project objectives.
• Understand and adhere to corporate standards regarding code of conduct, safety, appropriate handling of materials, and GxP compliance.

• Bachelor's Degree with typically 12 years, Master's Degree with typically 10 years, or PhD with typically 4 years of relevant experience.
• Possess thorough theoretical and practical understanding of pharmaceutical process engineering principles.
• Demonstrated experience in oral solid dosage form development and commercialization.
• Experience scaling manufacturing processes from laboratory and pilot scale to commercial production.
• Experience leading technology transfer activities across manufacturing sites.
• Working knowledge of process characterization, PPQ, and process validation principles.
• Experience applying Design of Experiments (DoE) and statistical approaches to process development.
• Knowledge of Quality by Design (QbD), risk assessment methodologies, and control strategy development.
• Effective writer and communicator of technical and regulatory documentation, including CTD submissions.
• Demonstrated ability to influence cross-functional teams and drive project execution.

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…