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.              

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.