Jason

Analytical CMC and Nitrosamine Specialist

Summary

Jason is an analytical CMC and impurity control specialist with extensive experience supporting development, regulatory submissions, technology transfer, and commercial manufacturing programs. He is widely recognized for his expertise in nitrosamine risk assessment, mitigation, analytical strategy, and control programs, helping organizations navigate complex regulatory expectations while minimizing development delays and lifecycle risk. Jason is known for developing practical, science-driven solutions that strengthen product quality, accelerate submissions, and support long-term commercial success.

Core Expertise

  • Nitrosamine Risk Assessment & Control Strategies
  • Analytical CMC Development & Regulatory Support
  • Method Development, Validation & Stability Programs
  • ICH Q3 Impurity Assessments
  • Technology Transfer & Quality Control Oversight

Career Highlights

  • Senior Consultant, Analytical CMC & Nitrosamines: Advised more than 20 manufacturers and marketing authorization holders on nitrosamine risk assessments, reformulation strategies, analytical challenges, and long-term control approaches.
  • Director, Analytical Sciences: Led analytical support for more than 20 development programs and established nitrosamine evaluation processes for multiple commercial products, delivering significant cost savings through proactive risk management and study design.
  • Analytical & Quality Leader: Directed analytical development, quality systems, method validation, stability testing, and regulatory support across clinical and commercial programs, including IND, NDA, and ANDA submissions.
  • Quality Control & Laboratory Operations Leader: Oversaw laboratory compliance initiatives, investigation procedures, method validation programs, and continuous improvement efforts supporting regulatory readiness and operational growth.

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