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Analytical Method Validation Specialist

1 month ago

St Louis, Missouri, United States Mallinckrodt Pharmaceuticals Full time
Job Title

Analytical Method Validation Specialist

Job Summary

The analytical method validation review specialist is responsible for conducting comprehensive reviews of analytical methods to ensure compliance with regulatory standards and suitability for intended use.

Key Responsibilities
  • Conduct in-depth reviews of analytical method validation protocols, procedures, and associated data.
  • Assess method performance against established acceptance criteria for parameters such as accuracy, precision, specificity, linearity, range, limit of detection, and limit of quantification.
  • Evaluate method robustness and ensure compliance with relevant regulatory guidelines (e.g., USP, Ph. Eur., ICH).
  • Prepare detailed reviewed reports summarizing findings, conclusions, and recommendations.
  • Participate in closure meetings with stakeholders to discuss review outcomes and gain approval.
  • Maintain accurate and organized documentation of review activities and findings.
  • Collaborate with cross-functional teams to address validation-related issues and implement corrective actions.
  • Stay updated on relevant regulatory requirements and industry best practices.
  • Independently develop project plans and timelines to achieve desired results with minimal oversight.
Requirements
  • BS in Chemistry, Chemical Engineering, or related science.
  • Minimum of 5 years' of pharmaceutical experience required with prior experience in analytical method validation and quality assurance experience.
  • Strong understanding of analytical chemistry principles and techniques.
  • Knowledge of pharmaceutical regulations including current GxP, GAMP5, Part 11, and Data Integrity requirements.
  • Knowledge of ICH Q7 and Q11 is required.
Preferred Skills
  • Excellent written and oral communication skills.
  • Proficiency in data analysis and interpretation.
  • Ability to work independently and as part of a team.
  • Understanding of basic statistical principles.
  • Complete understanding and application of principles, concepts, practices, and standards within discipline.
  • Knowledge of US and International pharmaceutical manufacturing regulations.
  • Moderate computer skills and familiarity with Microsoft Office Suite.
Competencies
  • Comfort Around Higher Management.
  • Organizational Agility.
  • Customer Focus.
  • Drive for Results.
  • Presentation Skills.
  • Managing through Systems.
  • Written Communication.
  • Decision Quality.
Organizational Relationship/Scope

Reports to the Principal Compliance Chemist. Must be self-directed to manage strategic/compliance projects and complaint investigations. Operates independently under limited supervision. Leads technical, cross-functional teams. Plans, schedules, and arranges own and other's activities in accomplishing objectives. Contacts involve matters of high importance to the organization and includes Customers, Commercial, Manufacturing, Quality, HSE, Engineering, and R&D.

Working Conditions