Manager - Analytical

Position Title: Manager - Analytical
Department: Analytical
Location: Vadodara
Reports To:

Job Overview:

The Manager - Analytical is responsible for overseeing the transfer of analytical methods from R&D or third-party laboratories to manufacturing or testing environments. The role ensures that analytical methods are validated, standardized, and transferred successfully while meeting regulatory standards and ensuring reliable testing results. This position also involves team leadership, cross-functional collaboration, and continuous improvement of analytical processes.

Key Responsibilities:

1. Review of Analytical Method Transfer Dossier (AMTD):
• Review and assess the Analytical Method Transfer Dossier, ensuring it includes all necessary documentation, protocols, validation reports, and method specifications.
• Verify compatibility of analytical methods with manufacturing site capabilities, equipment, and materials.
• Confirm that method transfer data adequately demonstrates performance metrics such as accuracy, precision, robustness, specificity, and sensitivity.
2. Assessment of Method Feasibility for Transfer:
• Evaluate the feasibility of transferring analytical methods from R&D to manufacturing or testing environments.
• Ensure appropriate equipment, instrumentation, and materials are available for method implementation.
• Assess reagent and standard suitability for consistent testing during transfer.
3. Collaboration with Cross-functional Teams:
• Collaborate with R&D, QC, QA, and Manufacturing teams to align method transfer requirements with regulatory standards and company objectives.
• Facilitate discussions and troubleshoot issues during method transfer to ensure progress.
4. Analytical Method Validation and Verification:
• Ensure proper validation and verification of analytical methods for accuracy and reliability.
• Review and confirm validation data to ensure consistency between R&D and manufacturing sites.
• Oversee the planning, execution, and documentation of validation and verification studies at the receiving site.
5. Documentation and Compliance:
• Ensure that all method transfer activities comply with GLP, GMP, and regulatory guidelines (e.g., FDA, EMA, ICH).
• Review and maintain thorough documentation, including protocols, reports, validation data, and training logs.
6. Risk Assessment and Troubleshooting:
• Conduct risk assessments to identify potential challenges during method transfer and propose mitigation strategies.
• Address and resolve issues related to method robustness, instrument compatibility, and reagent availability.
7. Training and Support:
• Train laboratory staff on new analytical methods to ensure accurate implementation.
• Provide ongoing support to address challenges and maintain consistency in method performance.
8. Continuous Improvement and Optimization:
• Identify opportunities to enhance analytical methods, streamline processes, or reduce costs without compromising quality.
• Stay updated on advances in analytical techniques and regulatory changes, integrating improvements as needed.
9. Reporting and Communication:
• Provide regular updates on method transfer progress, challenges, and milestones to stakeholders.
• Communicate effectively with cross-functional teams to ensure transparency and timely project completion.

Key Skills:

Technical Skills:

• Expertise in analytical techniques such as HPLC, GC, spectroscopy, and related methods.
• Strong understanding of method validation principles, statistical analysis, and troubleshooting of analytical methods.
• In-depth knowledge of regulatory requirements and industry standards for analytical testing.

Soft Skills:

• Excellent communication and interpersonal skills for effective collaboration with cross-functional teams.
• Attention to detail and organizational skills for managing method transfer documentation.
• Problem-solving abilities to address and resolve method transfer challenges.

Qualifications & Experience:

• Education: Masters degree in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or a related field.
• Experience:
• 10-15 years of experience in analytical chemistry, method development, and validation.
• Skills:
• Comprehensive knowledge of analytical techniques, equipment, and regulatory standards.
• Proven ability to lead and manage a team of approximately 10 members.