Analytical Development Laboratory (ADL) For Pharmaceutical Company

Job Description:

Key Responsibilities:

1. Method Development & Validation

• Develop analytical methods for assay, dissolution, related substances, and stability testing.

• Conduct method validation as per ICH guidelines (accuracy, precision, specificity, linearity, robustness).

• Optimize and troubleshoot existing analytical methods.

2. Instrument Handling

• Operate analytical instruments such as HPLC, GC, UV, FTIR, KF, Dissolution Apparatus, etc.

• Perform daily calibration and ensure instrument readiness.

3. Stability Studies

• Analyze stability samples as per stability protocols.

• Prepare stability reports and data interpretation.

4. Documentation & Reporting

• Prepare and maintain method development reports, validation protocols, COAs, raw data.

• Ensure compliance with cGMP, GLP, ALCOA+ and regulatory guidelines.

5. Support to Formulation Development

• Provide analytical support during R&D trials, scale-up, exhibit batches, and technology transfer.

• Evaluate prototype formulations using analytical parameters.

6. Regulatory Support

• Prepare analytical documents for ANDA, DMF, CTD submissions.

• Support responses to regulatory queries related to analytical methods.

7. Lab Compliance

• Maintain lab safety, instrument calibration, reagent management, and SOP adherence.

• Participate in internal audits and ensure continual improvement.

Desired Profile / Criteria / Skills :

Required Skills & Qualifications

• B.Sc / M.Sc (Chemistry) or B.Pharm / M.Pharm

• 1–8 years experience in ADL (Formulation)

• Strong knowledge of HPLC/GC method development, ICH guidelines, R&D support

• Good understanding of analytical chemistry and pharma regulations

• Proficiency in documentation and data integrity practices