Executive - Analytical Development

Sun Pharmaceutical Industries, Inc.; Vadodara; On-site; INR 600,000 - 1,000,000; Full time

Job summary

Sun Pharmaceutical Industries, Inc. is looking for an Executive Analytical Development professional to develop and optimize analytical methods for various drug products. Key responsibilities include establishing methods for assay and dissolution, performing forced degradation studies, and executing method validation according to ICH Q2(R1) guidelines.

The ideal candidate will hold an M.Sc. or M.Pharm in a relevant field and should have hands-on experience with analytical instrumentation like HPLC and UV-Visible Spectrophotometry. Strong collaboration with formulation and QA teams is expected.

Qualifications

• Experience in developing and optimizing analytical methods for drug products.
• Familiar with ICH Q2(R1) guidelines for method validation.
• Ability to work collaboratively with formulation development and QA teams.

Responsibilities

• Develop and optimize analytical methods for APIs and drug products.
• Establish assays, dissolution, and related substance methods.
• Perform forced degradation studies and method validation.

Skills

Analytical methods development

Method validation

HPLC / UPLC

Instrument calibration

Impurity profiling

Education

M.Sc. in Analytical Chemistry / Organic Chemistry / Pharmaceutical Chemistry / M.Pharm (Pharmaceutics)

Tools

HPLC

UV-Visible Spectrophotometer

Dissolution apparatus

GC

Job description

Title

Executive Analytical Development Orals

Location

Tandalja - R&D

Company

Sun Pharmaceutical Industries Ltd

Business Unit

R&D1 Regulatory Affairs

Job Grade

G12A

Job Description

• Develop and optimize analytical methods for APIs and drug products (tablets, capsules, granules, suspensions etc).
• Establish methods for assay, dissolution, related substances, degradation products, and content uniformity.
• Perform forced degradation studies to establish stability‑indicating methods.
• Execute method validation as per ICH Q2(R1) guidelines.
• Prepare validation protocols and reports.
• Perform impurity profiling and method development for new products.
• Support formulation team with analytical inputs during product development.
• Operate and troubleshoot instruments such as:
  • HPLC / UPLC
  • Dissolution apparatus
  • UV-Visible Spectrophotometer
  • GC (if applicable)
• Instrument calibration and compliance.
• Work with formulation development, QA, regulatory affairs, and stability teams.

Educational Qualification

M.Sc. in Analytical Chemistry / Organic Chemistry / Pharmaceutical Chemistry / M.Pharm (Pharmaceutics) preferred

Disclaimer

The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).