Senior Executive, Analytical Development

Amneal Pharmaceuticals; Ahmedabad District; On-site; INR 800,000 - 1,200,000; Full time

Job summary

Amneal Pharmaceuticals in Ahmedabad invites an Analytical Scientist for the ARD department. The role requires 3–5 years of biosimilar analytical development experience and hands-on physicochemical characterization using HPLC/UPLC, CE, UV, and protein analytics.

You will develop/qualify methods, support upstream/downstream/formulation activities, and ensure GMP/GLP compliance. Strong technical writing, data interpretation, and cross-functional collaboration are essential for success in this

Qualifications

• Master's degree in biotechnology, biochemistry, analytical chemistry, or a related life sciences field.
• 3–5 years of biosimilar/ biologics analytical development experience.
• Hands-on experience with physicochemical characterization techniques.

Responsibilities

• Perform physicochemical characterization of biosimilar products using state-of-the-art analytical techniques.
• Develop, optimize, qualify, and troubleshoot analytical methods for product characterization and comparability assessment.
• Provide analytical and in-process support for upstream, downstream, and formulation development activities.
• Execute routine and non-routine analytical testing, data analysis, and technical report preparation.
• Ensure compliance with GMP, GLP, data integrity, and regulatory requirements.

Skills

Analytical method development

Data interpretation

Technical writing

Cross-functional collaboration

Education

MSc/MTech in Biotechnology/Biochemistry/Analytical Chemistry or related life sciences

Tools

HPLC/UPLC

CE

UV

Protein analytics

Job description

• Department: Analytical Research & Development (ARD)
• No. of Positions: 20

Job Description

Job Overview

• Job Title: Analytical Scientist
• Experience Level: 3 to 5 Years
• Department: Analytical Research & Development (ARD)
• Location: Ahmedabad
• No. of Positions: 20

Key Responsibilities

• Perform physicochemical characterization of biosimilar products using state-of-the-art analytical techniques.
• Develop, optimize, qualify, and troubleshoot analytical methods for product characterization and comparability assessment.
• Provide analytical and in-process support for upstream, downstream, and formulation development activities.
• Execute routine and non-routine analytical testing, data analysis, and technical report preparation.
• Ensure compliance with GMP, GLP, data integrity, and regulatory requirements.

Qualifications

• Master's degree (M.Sc./M.Tech) in Biotechnology, Biochemistry, Analytical Chemistry, or a related life sciences field.
• 3 to 5 years of experience in biosimilar/biologics analytical development.
• Hands-on experience in physicochemical characterization techniques such as HPLC/UPLC, CE, UV, and protein analytics.
• Strong understanding of analytical method development, qualification, and troubleshooting.
• Good technical writing, data interpretation, and cross-functional collaboration skills.