Executive - Formulation Development

Role & responsibilities

Formulation Analytical Research & Development (AR&D) Executive

Department: Formulation AR&D
Designation: Executive – AR&D
Function: Analytical Development / Formulation Research & Development

1. Job Purpose

To perform analytical method development, method optimization, method validation, and analytical testing of pharmaceutical formulations in accordance with applicable regulatory requirements, approved specifications, and Good Laboratory Practices (GLP).

2. Key Responsibilities

• Develop, optimize, and validate analytical methods for pharmaceutical formulations using HPLC, UPLC, UV-Visible spectrophotometry, and other relevant analytical instruments.
• Perform analytical testing of formulation development batches, pilot batches, exhibit batches, stability samples, and finished products.
• Execute analytical method transfer activities and support technology transfer from R&D to Quality Control (QC).
• Perform forced degradation studies and support the establishment of stability-indicating analytical methods.
• Conduct stability sample analysis as per ICH guidelines and approved stability protocols.
• Perform related substances, assay, dissolution, content uniformity, and other applicable pharmaceutical analytical tests.
• Prepare and review analytical method development reports, method validation protocols and reports, analytical method transfer documents, and stability reports.
• Maintain laboratory records, raw data, chromatograms, calculations, and documentation in compliance with ALCOA+ data integrity principles.
• Investigate analytical deviations, atypical results, and out-of-specification (OOS) or out-of-trend (OOT) results, as applicable.
• Ensure proper calibration, maintenance, and routine performance checks of analytical instruments.
• Coordinate with Formulation Development, Quality Control, Quality Assurance, and Regulatory Affairs teams for project execution and documentation.
• Follow laboratory safety procedures, SOPs, GLP, GMP requirements, and applicable regulatory guidelines.

3. Technical Skills

• Hands-on experience in HPLC/UPLC and UV-Visible spectrophotometry.
• Knowledge of analytical method development, optimization, validation, and verification.
• Understanding of ICH guidelines, particularly Q1, Q2, and Q14, as applicable.
• Knowledge of pharmaceutical formulation analysis, dissolution testing, and stability studies.
• Familiarity with chromatography data systems, laboratory instruments, and electronic data integrity requirements.
• Ability to prepare technical reports, protocols, SOPs, and other analytical documentation.

4. Educational Qualification

M.Sc. in Analytical Chemistry, Organic Chemistry, Pharmaceutical Chemistry, or an equivalent relevant qualification.

5. Experience

Typically, 2–5 years of relevant experience in Analytical R&D or Formulation Development support in a pharmaceutical R&D center. The required experience may vary depending on organizational requirements.

6. Key Competencies

• Analytical thinking and problem-solving skills.
• Attention to detail and data integrity.
• Good documentation and report-writing skills.
• Effective communication and cross-functional coordination.
• Ability to manage multiple analytical activities and meet project timelines.