Sr. Executive/AM - ADL (R&D).

Job Description (JD)Sr. Executive / Assistant Manager – ADL (R&D)

Department: Research & Development (R&D) – Analytical Development Laboratory (ADL)
Qualification: M.Sc. / M. Pharma
Industry: Pharmaceutical / Formulation Development
Experience: Relevant experience in Analytical Development Laboratory (ADL) within pharmaceutical R&D

Job Summary

We are looking for a skilled and detail-oriented Sr. Executive / Assistant Manager – ADL (R&D) to develop, validate, and execute analytical methods for raw materials, intermediates, and finished Oral Solid Dosage (OSD) products. The ideal candidate should have hands-on experience in analytical method development, method validation, stability studies, and regulatory compliance within the pharmaceutical industry.

Key Responsibilities

• Develop, optimize, and validate analytical methods for raw materials, intermediates, and finished pharmaceutical products, particularly OSD formulations.
• Perform routine and developmental analysis, including assay, dissolution, impurity profiling, and stability testing.
• Operate and troubleshoot analytical instruments such as HPLC, GC, UV-Visible spectrophotometers, and dissolution apparatus.
• Prepare and review analytical method development reports, method validation protocols, validation reports, and stability study documentation.
• Generate, review, and maintain accurate analytical data for regulatory submissions and technical documentation.
• Provide analytical support to formulation development, scale-up activities, and technology transfer.
• Ensure compliance with Good Laboratory Practices (GLP), ICH guidelines, applicable pharmacopoeial standards, and regulatory requirements.
• Maintain laboratory instruments and equipment, ensuring timely calibration, qualification, and preventive maintenance.
• Investigate out-of-specification (OOS) and out-of-trend (OOT) results, analytical deviations, and laboratory discrepancies.
• Maintain laboratory documentation, data integrity, and standard operating procedures (SOPs).
• Coordinate with formulation development, quality assurance, quality control, and other cross-functional teams to support project timelines.

Required Skills and Competencies

• Strong knowledge of analytical method development and validation for pharmaceutical formulations.
• Hands-on experience with HPLC, GC, UV-Visible spectroscopy, and dissolution testing.
• Understanding of assay, related substances, impurity profiling, and stability studies.
• Knowledge of ICH guidelines, GLP, pharmacopoeial requirements, and regulatory documentation.
• Familiarity with OOS/OOT investigations, troubleshooting, and laboratory compliance.
• Strong analytical, problem-solving, documentation, and communication skills.
• Ability to manage multiple analytical activities while maintaining accuracy and quality standards.

Educational Qualification

• M.Sc. in Chemistry / Analytical Chemistry or a relevant discipline, or
• M. Pharma in a relevant specialization.

Preferred Candidate Profile

• Experience in pharmaceutical R&D, specifically Analytical Development Laboratory (ADL).
• Exposure to Oral Solid Dosage (OSD) formulations.
• Practical knowledge of analytical method development, validation, stability studies, and technology transfer.
• Candidates with relevant experience in regulated pharmaceutical environments will be preferred.

Pay: ₹700,000.00 - ₹800,000.00 per year

Work Location: In person