Principal Scientist - Process Analytical Technology

Role Summary

Role: Principal Scientist, Process Analytical Technology. You will implement process analytical technology (PAT) in a fast-paced, customer-oriented laboratory/production environment to support API and Drug Product manufacturing. Identify, develop, and deliver PAT applications for commercial manufacturing, support the PAT program and Operational Excellence using advanced analytical, chemometric, and data science skills to enhance process performance and knowledge. You will support product transfers, new product development, and cost improvement projects.

Responsibilities

• Implement technical solutions and analytical strategies using PAT.
• Lead adoption and use of PAT instruments and machine learning models.
• Assess feasibility and ensure technical soundness of instruments/models for process monitoring and control.
• Apply scientific concepts across chemistry, PAT, and data science with high learning agility.
• Support automation development between PAT tools and process data systems (e.g., AVEVA Pi).
• Mentor and develop scientific staff; promote growth and knowledge sharing.
• Plan and manage short- and long-term development activities, timelines, and resource allocation.
• Foster diverse perspectives to drive innovative solutions.
• Coordinate instrumentation usage across projects for equitable access.
• Contribute to technical documentation (SOPs, tech transfer, process diagrams, regulatory submissions).
• Ensure compliance with development quality, regulatory, HSE, GLP, and GMP requirements.

Qualifications

• Required: Bachelor’s degree with at least 4 years of experience; OR Master’s degree with at least 2 years of experience; OR PhD with 0+ years of experience; OR Associate’s degree with 8 years of experience; OR high school diploma (or equivalent) and 10 years of relevant experience.
• Preferred: Minimum 3 years of production-applicable PAT experience; broad spectroscopy background with multi-variate data analysis; demonstrated programming ability in R, Python, and/or MATLAB.

Skills

• Process Analytical Technology (PAT) application and strategy development
• Machine learning models and data science for process control
• Multi-variate data analysis and spectroscopy
• Programming in R, Python, and/or MATLAB
• Technical documentation and regulatory submission support

Education

• Bachelor’s degree with 4+ years of experience or equivalent; or Master’s degree with 2+ years; or PhD with 0+ years; or Associate’s degree with 8 years; or high school diploma with 10 years of relevant experience

Additional Requirements

• Physical/Mental: Work in a laboratory/production environment; standing for long periods and handling chemicals; ability to perform complex data calculations.
• Non-standard Schedule/Travel: May require off-hours, weekends, and/or holidays to meet business or customer needs.