Senior Scientist, Engineering II Full-time

Job Title

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.

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.

Qualifications

• 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.

Additional Information

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 long-term incentive programs.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.