Provide technical leadership for systematic assessment and deployment of in-line, on-line, and at-line PAT methods across small
and large-molecule programs
Design and develop standardized analytical platforms to enable PAT implementation, including real-time monitoring and rapid shop-floor analytics
Develop, validate, and implement PAT methods (in-line, on-line, at-line) to monitor and control process parameters and product quality attributes
Lead scale-up activities and technology transfer of PAT applications to commercial manufacturing
Partner with capital project and facility teams to design and establish integrated PAT infrastructure aligned with the Launch Preparedness strategy
Create integrated control strategies that leverage PAT platforms to enable robust, highly capable manufacturing processes across modalities (e.g., small molecule drug product, biologics, and vaccines)
Prepare and maintain scientific documentation and validation packages for PAT methods; contribute content for regulatory submissions
Interact with global regulatory agencies as needed to support acceptance of PAT-based process control and release strategies

B.S. in chemistry, biochemistry, biotechnology, bioengineering, chemical engineering, or a related discipline with a minimum of 12 years of relevant industry experience; or M.S. with at least 8 years; or Ph.D. with at least 4 years
Demonstrated experience in PAT
Strong technical background in spectroscopy (Raman, FTIR, NIR), chromatography, and chemometric/modeling approaches
Proven track record of scientific contributions (peer-reviewed publications or equivalent technical outputs)
Preferred Experience preparing PAT content for regulatory filings and interacting with regulatory agencies
Experience with PAT implementation in commercial manufacturing and technology transfer
Strong collaborative and interpersonal skills; ability to work across functions and with external partners
Project leadership and the ability to manage multiple priorities in a fast-paced environment

medical, dental, vision healthcare and other insurance benefits (for employee and family)
retirement benefits, including 401(k)
paid holidays
vacation
compassionate and sick days

Associate Principal Scientist, Process Analytical Technologies

Key skills