Senior Executive, Analytical Development

Amneal India; Ahmedabad District; On-site; INR 700,000 - 1,100,000; Full time

Job summary

Amneal India is seeking a Senior Executive, Analytical Development in Ahmedabad to lead physicochemical characterization and method development for biosimilar programs. You will support upstream, downstream, and formulation development, and ensure GMP/GLP compliance through robust data integrity and documentation.

The successful candidate will have a Master's in life sciences and 3–5 years of hands-on experience with HPLC/UPLC, CE, UV, and protein analytics, along with strong technical writing

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 physicochemical characterization using 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.

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 & 1

HPLC Method Validation

HPLC Troubleshooting

Technical Writing

UPLC Instrumentation Expertise

Education

Master's degree in Biotechnology/Biochemistry/Analytical Chemistry

Tools

HPLC

UPLC

CE

UV

Protein Analytics

Job description

Senior Executive, Analytical Development

Ahmedabad City, Gujarat, India

Trending

Job Description

Job Overview

Job Title: Analytical Scientist

Experience Level: 3 to 5 Years

Department: Analytical Research & Development (ARD)

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.

Required Skills

• Analytical Method Development & Validation
• HPLC Method Validation
• HPLC Troubleshooting
• Technical Writing
• UPLC Instrumentation Expertise