Principal Scientist, Process Analytical Technology Industrialisation

Role Summary

Principal Scientist in Process Analytical Technology Industrialisation, Global Product Development. Join the Operations team in Durham, NC, to drive enhanced control strategies for commercial manufacturing and to contribute to cutting-edge analytical sciences across PAT, chemometrics, and data-driven approaches.

Responsibilities

• Drive design, development, and validation of high-quality enhanced control strategies using PAT, chemometrics, advanced process monitoring and control tools, quality systems, and global regulations.
• Collaborate with cross-functional teams, contribute to regulatory documentation, and lead projects implementing innovative monitoring and control tools across global commercial manufacturing platforms with a focus on continuous manufacturing.
• Drive standards and apply Lean in the validation and technical transfer of models and PAT tools supporting product control strategies across Operations.
• Deliver digitally oriented approaches, including data science, predictive modelling, simulation, and artificial intelligence.

Qualifications

• Required: Master's degree
• Required: Minimum of 10 years industrial experience (Analytical Chemistry, Pharmaceutical Sciences, or Engineering)
• Required: Demonstrated delivery in PAT, advanced process control or model predictive control in late phase/early commercial pharmaceutical manufacturing including technology transfer
• Required: Proficiency with ICH guidelines (Q2, Q8, Q9, Q10, Q13, Q14), Quality by Design, and development/implementation of enhanced control strategies
• Required: Experience in authoring NDA/MAA sections and supporting PPQ/CPV/PAI
• Required: Expert knowledge of pharmaceutical process equipment/technology for continuous processes
• Required: Demonstrated compliance with GMP, GAMP, Process Safety, Data integrity, Change Control
• Required: Understanding of Safety, Health & Environment (SHE)

Desirable

• PhD Degree
• Experience with contract manufacturing organisations delivering PAT solutions
• Strong publication/patent/conference record in PAT
• Demonstrated leadership with direct or matrix management of scientists
• Experience deploying PAT in manufacturing technologies for multiple formulations (oral, inhaled, injectables)
• Knowledge of PAT in development or manufacturing of combination products