Domain SME Lead

Domain SME: Key Responsibilities

• 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.