Head - Analytical Development Laboratory/Formulation R&D

Job Summary:

The Head of Analytical Development Laboratory (ADL) will lead a team of scientists and analysts in the development and validation of analytical methods to support formulation development of solid oral dosage forms (primarily tablets). The role includes oversight of analytical method development, validation, stability studies, regulatory documentation, and ensuring compliance with global quality standards (e.g., ICH and EMA).

Key Responsibilities:

1. Analytical Strategy & Execution

- Lead the development and validation of analytical methods (e.g., assay, dissolution, content uniformity, impurities).

- Oversee analytical support for formulation development, scale- up, and technology transfer activities.

- Guide characterization of drug substances and drug products using techniques such as HPLC, UPLC, GC, UV, FTIR, DSC, XRD, and particle size analysis.

2. Stability Studies

- Design and monitor stability protocols per ICH guidelines.

- Interpret stability data and provide support for shelf- life determination and formulation decisions.

3. Regulatory & Documentation

- Ensure timely generation of high- quality analytical documents for regulatory submissions.

- Review analytical method validation protocols, reports, and stability reports.

- Well versed with Regulatory query responses.

4. Quality & Compliance

- Ensure adherence to regulatory standards.

- Coordinate with Quality Assurance for audit readiness and data integrity practices.

5. Team Leadership & Development

- Lead and mentor a team of scientists/analysts (more than 20).

- Foster a culture of scientific rigor, innovation, and continuous improvement.

Key Requirements:

Education: M.Pharm / M.Sc / Ph.D. in Pharmaceutical Sciences, Analytical Chemistry, or related field.

Experience:

- 15+ years of experience in analytical development in the pharmaceutical industry.

- Significant experience with oral solid dosage forms (tablets) and regulatory submissions.

Skills & Competencies:

1. Strong understanding of analytical techniques and instrumentation.

2. Familiarity with global regulatory guidelines (EMA, ICH, etc.).

3. Excellent leadership, communication, and problem- solving skills.

4. Experience with Empower, Lab solutions, and data integrity tools.

Preferred:

- Experience with QbD principles in analytical development.

- Hands- on with characterization of complex generics (e.g., MR tablets, fixed- dose combinations).