Principal PAT Scientist

In this role, the incumbent is responsible for developing Process Analytical Technology (PAT) methods and off-line Analytical Development/Validation methods to support process chemistry development and manufacturing related to active pharmaceutical ingredients (APIs) including continuous and flow processes. This work includes collecting data, building chemo metric models, and integrating PAT and analytical method development/validation at the bench scale to monitor and characterize continuous flow processes.

The incumbent may execute 60% - 80% of their work at the bench level.

• Work with a group of innovative scientists to support process development and manufacturing activities for APIs, as well as analytical troubleshooting.
• Interact closely with manufacturing and external partners in identifying, implementing, and troubleshooting test methods and workflows for ensuring compliant, robust API manufacturing process.
• Develop and validate analytical methods through collaboration to develop at‑line and in‑line PAT methods and models for assessing the quality of batch and continuous manufacturing processes.
• Provide analytical support to process development groups.
• Perform analyses and method development using a variety of analytical methods such as spectroscopy, chromatography, and mass spectrometry.
• Perform peer‑reviews of analytical data and reports.
• Write final reports and prepare slides for presentations.
• Document project progresses, track and report the status of assignments to management on a regular basis.
• Work with cross‑functional teams within the organization to solve both technical and process‑related issues.
• Serve as technical expert and champion for PAT and/or process model building.
• Recommend and implement new approaches or processes to improve laboratory operations.
• Assist lab head in planning, implementing, and evaluating laboratory procedures/systems.
• Attend scientific seminars and conferences and make presentations.
• Help in establishing Quality systems in the laboratory.
• Lead or assist in technology transfer activities.

• Principal Analytical Chemist:
  • Ph.D. in chemistry or related field with at least five (5) years of relevant laboratory experience, or an MS in chemistry or related field with ten (10) years of experience or a BS in chemistry or related field with fifteen (15) years of experience
• Sr. Principal Analytical Chemist:
  • Ph.D. in chemistry or related field with at least ten (10) years of relevant laboratory experience, or an MS in chemistry or related field with fifteen (15) years of experience or a BS in chemistry or related field with twenty (20) years of experience