What are the responsibilities and job description for the Global PAT Lead position at Proclinical Staffing?
Global PAT Lead - Permanent - North Carolina
Help bring science to life and join a leading pharmaceutical company to play a key role in delivering impactful research that drives healthcare innovation!
Proclinical is seeking a Global PAT Lead to support the development and implementation of advanced control strategies in commercial pharmaceutical manufacturing.
Primary Responsibilities:
This role focuses on leveraging expertise in Process Analytical Technology (PAT), chemometrics, and advanced monitoring tools to drive innovation and ensure compliance with global regulations. You will collaborate across teams, contribute to regulatory documentation, and lead projects aimed at enhancing manufacturing platforms, with a strong emphasis on continuous manufacturing.
Skills & Requirements:
- Advanced degree in Analytical Chemistry, Pharmaceutical Sciences, or Engineering.
- Expertise in PAT, advanced process control, and model predictive control in pharmaceutical manufacturing.
- Familiarity with ICH guidelines (Q2, Q8, Q9, Q10, Q13, Q14) and Quality by Design principles.
- Experience authoring regulatory documentation and supporting PPQ, CPV, and PAI processes.
- Knowledge of pharmaceutical process equipment and technologies for continuous manufacturing.
- Strong understanding of GMP, GAMP, process safety, data integrity, and change control.
- Innovative mindset with experience in data science, predictive modeling, and AI applications.
- Desirable: PhD degree, experience with contract manufacturing organizations, and knowledge of combination product development.
The Global PAT Lead's responsibilities will be:
- Design, develop, and validate high-quality enhanced control strategies using PAT and advanced process monitoring tools.
- Collaborate with cross-functional teams to implement innovative monitoring and control tools globally.
- Drive standards and apply Lean principles in the validation and technical transfer of models or PAT tools supporting product control strategies.
- Contribute to regulatory documentation and ensure compliance with GMP, GAMP, process safety, data integrity, and change control requirements.
- Lead projects focused on continuous manufacturing and digitally oriented approaches, including predictive modeling, simulation, and artificial intelligence.
- Provide expert advice on ICH guidelines and Quality by Design principles.
- Support technology transfer and ensure operational compliance during late-phase and early commercial pharmaceutical manufacturing.
If you are having difficulty in applying or if you have any questions, please contact Ed Little at e.little@proclinical.com
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
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