Ai Lead Architect

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Protocol Development & Method Validation Design and review analytical protocols for pharmaceutical products. Validate methods in accordance with ICH, USP, EP, and other regulatory guidelines. Regulatory Compliance Validation Ensure adherence to global regulatory standards for analytical methods. Conduct compliance checks and maintain documentation for audits. Method Optimization & Logic Development Develop optimization logic for analytical methods to improve efficiency and accuracy.

Implement risk-based approaches for method selection and validation. Technical Leadership Act as a domain expert for cross-functional teams in R&D and Quality Assurance. Provide guidance on regulatory submissions and technical dossiers. Knowledge Management Maintain up-to-date knowledge of pharmacopeial standards and regulatory changes. Train teams on best practices for compliance and method development.

Required Skills & Qualifications Strong expertise in protocol generation, method validation, and regulatory compliance. In-depth knowledge of USP, EP, ICH guidelines, and global pharmacopeial standards. Experience in method optimization logic and analytical risk assessment. Excellent documentation and audit readiness skills. Strong communication and stakeholder management abilities.

Preferred Qualifications Hands‑on experience with regulatory submissions and compliance audits. Familiarity with automation tools for method validation and optimization. Advanced degree in Pharmaceutical Sciences, Analytical Chemistry, or related field.

• Mid‑Senior level

• Full‑time

• Design, Art/Creative, and Information Technology

• IT Services and IT Consulting

New York, NY $-$