Senior Scientist, Engineering II

AbbVie•North Chicago, IL

3d•$109,500 - $208,500•Onsite

About The Position

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.

Requirements

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.

Responsibilities

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.