Asst. Manager/ Manager-Analytical Development Laboratory

Department: Analytical Development Laboratory

Designation: Assistant Manager / Manager

Roles & Responsibilities:

To lead Analytical Development activities for pharmaceutical products with focus on development of robust, scientifically justified and regulatory-compliant analytical methods suitable for regulated markets.

The role shall ensure right-first-time analytical development, effective method validation and transfer to QC, strong technical documentation, data integrity, timely troubleshooting and prevention of avoidable analytical errors through appropriate scientific and experience-based review.

1. Analytical Method Development & Lifecycle Management

• Plan, develop, optimize and oversee analytical methods for Raw Materials, In-Process samples, Finished Products, Cleaning Validation and other development requirements.

• Manage the complete analytical method lifecycle including:

• Method Development

• Method Optimization

• Method Validation / Verification

• Analytical Method Transfer (AMT)

• Method changes and lifecycle improvements

• Ensure methods are robust, reproducible, stability-indicating where required, and practically transferable to QC.

• Provide hands-on technical support for analytical development of Tablets, Capsules, Ointments, Creams, Gels and other applicable dosage forms.

• Review analytical challenges early and select appropriate techniques, columns, sample preparation, standards and method conditions to minimize development failures and repeat work.

2. Regulatory & Scientific Compliance

• Ensure analytical development and validation activities meet applicable ICH, pharmacopoeial and regulatory market requirements, including expectations for regulated markets such as the EU.
• Ensure appropriate scientific justification is available for method parameters, specifications, validation strategy and analytical decisions.
• Review pharmacopoeial requirements such as Ph. Eur., BP, USP and other applicable compendia during analytical development.
• Maintain awareness of evolving regulatory expectations and incorporate relevant requirements into ADL practices.
• Ensure Good Laboratory Practices (GLP), Good Documentation Practices (GDP) and applicable data-integrity requirements are followed throughout the laboratory.

3. Validation, Verification & Technical Documentation

• Prepare, review and approve protocols, specifications, STPs, worksheets and reports related to:

• Analytical Method Validation

• Method Verification

• Analytical Method Transfer

• Cleaning Validation

• Stability and development studies

• Ensure validation parameters and acceptance criteria are scientifically appropriate and adequately justified.

• Review ADL technical documents for accuracy, completeness, traceability and regulatory acceptability before approval.

• Ensure raw data, calculations, chromatograms, audit trails and supporting records are properly reviewed and documented.

4. Analytical Troubleshooting & Error Prevention

• Provide technical guidance for analytical problems including method failures, inconsistent results, system suitability failures and atypical chromatographic behaviour.
• Review recurring analytical issues and identify root causes rather than relying on repeated testing or temporary corrections.
• Participate in investigations related to OOS, OOT, deviations, laboratory incidents and analytical errors, wherever applicable.
• Ensure appropriate CAPA and preventive actions are implemented for significant or recurring laboratory issues.
• Apply prior experience and risk-based technical review to identify potential errors during development, validation and transfer before they affect regulatory batches or stability studies.
• Promote a right-first-time and scientifically driven approach within ADL.

5. Stability & Development Support

• Plan and monitor analytical activities related to development, exhibit / registration and stability batches.
• Review stability results, trends, chromatographic data and analytical observations for potential concerns.
• Support investigation of stability-related OOS, OOT or unusual trends.
• Coordinate closely with Formulation R&D, Regulatory Affairs, QA and QC to ensure analytical requirements are completed as per development and submission timelines.

6. Analytical Method Transfer to QC

• Plan and coordinate Analytical Method Transfer from ADL to QC.
• Ensure QC analysts are adequately trained on new analytical methods before transfer execution.
• Ensure methods developed by ADL are practical, reproducible and capable of routine execution in QC.
• Provide technical support during transfer, validation and initial commercial / process-validation batch analysis.
• Investigate transfer failures and ensure appropriate corrective actions before final method handover.
• Ensure learnings during transfer are incorporated into methods, STPs and training wherever required.

7. Laboratory Operations, Instruments & Data Integrity

• Oversee day-to-day activities of ADL and ensure proper planning and prioritization of analytical work.
• Ensure analytical instruments and equipment are appropriately qualified, calibrated and maintained.
• Review calibration records, equipment logbooks, instrument usage and other critical laboratory documentation.
• Ensure proper handling and control of reference standards, working standards, columns, reagents and laboratory solutions.
• Ensure laboratory data is generated, reviewed and maintained in accordance with ALCOA+ and applicable data-integrity principles.
• Ensure proper utilization and compliance of computerized analytical systems and chromatography software.

8. QMS, Audits & Regulatory Readiness

• Support and handle ADL-related:

• Deviations

• OOS / OOT investigations

• CAPA

• Change Controls

• Risk Assessments

• Participate in internal audits, customer audits and regulatory inspections.

• Ensure ADL documentation and systems remain continuously audit-ready.

• Provide technical explanations and supporting documents during regulatory and customer audits.

• Ensure timely closure of ADL-related audit observations and compliance actions.

9. Team Management & Development

• Plan and allocate work to ADL team members based on project priorities and timelines.
• Review analytical work performed by team members and provide technical guidance wherever required.
• Identify competency gaps and provide training in method development, validation, troubleshooting, documentation and regulatory expectations.
• Develop analysts to understand the scientific reasoning behind methods, rather than following procedures mechanically.
• Promote accuracy, accountability, data integrity, timely execution and continuous learning within the team.

10. General Responsibilities

• Coordinate effectively with Formulation R&D, QC, QA, Regulatory Affairs and other concerned departments.
• Support regulatory submissions by providing analytical data, reports and technical clarifications.
• Drive continuous improvement in analytical practices, systems and laboratory productivity.

Perform any other ADL / R&D responsibilities assigned by Management from time to time.

Highest Qualification: B.Pharm/M.Pharm/M.Sc

Skills Required: Experience in a pharmaceutical formulation company handling regulated-market products, particularly EU / UK / other regulated markets, will be strongly preferred.