Research Associate - ADL Method Validation

Alkem Labs; Daman; On-site; INR 600,000 - 900,000; Full time

Job summary

Alkem Labs is seeking a skilled analytical chemist to join our cGMP laboratory in India. You will operate HPLC (Empower), GC, IC and dissolution equipment, and contribute to method validation and verification for drug products across multiple markets.

You will work with eLIMS, Trackwise and eDMS to document results, uphold data integrity, and ensure compliance with regulatory standards. Strong analytical skills and attention to detail are essential for success in this role.

Qualifications

• Experience in a cGMP laboratory.
• HPLC (Empower), GC, IC and dissolution equipment knowledge.
• Dissolution testing across media for different markets.
• Method validation/verification for drug products.
• Experience with electronic lab systems: eLIMS, Trackwise, eDMS.

Responsibilities

• Operate HPLC (Empower), GC, IC and dissolution apparatus; support PSD and titrimetric work.
• Work in a cGMP laboratory environment.
• Dissolution testing on different media for various markets.
• Perform method validation and verification for drug products.
• Work with eLIMS, Trackwise and eDMS to document results.
• Maintain good analytical skills and data integrity.

Skills

Analytical skills

Good analytical skills

Education

Master's degree in chemistry, Pharmacy, or related field

Tools

eLIMS

Trackwise

eDMS

Job description

Role Description

• HPLC (Empower software), GC, Ion Chromatography, Dissolution apparatus knowledge (desirable for PSD, Titrimetric analysis)
• Must be working in cGMP Laboratory.
• Dissolution on different media for Various market
• Method Validation/Verification for drug products
• Working on eLIMS, Trackwise, eDMS (compulsory)
• Good analytical skills

Qualifications

• Master's degree in chemistry, Pharmacy, or related field