Asst. Manager/ Manager-Analytical Development Laboratory

Leben Life Sciences; Akola District; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Leben Life Sciences in India seeks an Assistant Manager/Manager in Analytical Development Laboratory to lead development activities for pharmaceutical products, ensuring robust, scientifically justified methods for regulated markets. The role emphasizes right-first-time development, validation, transfer to QC, and meticulous documentation to meet regulatory expectations.

You will oversee lifecycle management of analytical methods, support regulatory readiness, and guide the team in ensuring data

Qualifications

• Analytical development expertise required for regulated markets.
• Ability to ensure right-first-time development and data integrity.

Responsibilities

• Lead analytical development activities for pharmaceutical products across dosage forms.
• Ensure GLP/GDP and data integrity in development, validation and transfer to QC.
• Coordinate method development, validation, transfer and lifecycle management.
• Support CAPA, OOS/OOT investigations and regulatory readiness.

Education

B.Pharm/M.Pharm/M.Sc

Job description

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.