Research Associate - ADL

Kopran Limited; Khopoli; On-site; INR 900,000 - 1,200,000; Full time

Job summary

Kopran Limited in Khopoli, India seeks an Analytical Chemist to perform routine analysis of formulation development and stability samples while ensuring instrument calibration and method transfer to QC labs.

The role requires hands-on work with HPLC, Dissolution, UV-VIS, and Karl-Fischer equipment, with emphasis on GLP, documentation, and cross-functional collaboration with R&D, Tech Transfer, and QA teams.

Qualifications

• Experience in Analytical Method Development with practical execution
• Knowledge of GLP, data integrity and documentation systems
• Ability to prepare and review Specifications and STP as per pharma standards

Responsibilities

• Plan and execute analysis of formulation development and stability samples within predefined timelines
• Ensure routine calibration and operation of HPLC, Dissolution, UV-VIS, and KF instruments
• Assist in developing stable analytical methods and transfer them to plant QC labs
• Prepare, review and finalize Specifications, STPs, and analytical reports
• Review and submit analytical reports promptly to minimize project lag times
• Guide junior analysts and troubleshoot during analysis for 4–5 years experience
• Collaborate with Formulation R&D, Tech Transfer, and Quality Assurance teams to ensure seamless progression

Skills

Method Development

Method Validation

Method Transfer

GLP Compliance

Documentation Management

Tools

HPLC

Dissolution

UV-VIS

Karl-Fischer

Job description

Role & responsibilities

• Routine Analysis: Plan and execute the analysis of formulation Development and Stability samples within predefined timelines.
• Instrument Upkeep: Ensure routine calibration and smooth operation of critical laboratory instruments (HPLC, Dissolution, UV-VIS, KF).
• Method Execution: Assist in developing stable analytical methods and completing their validation and subsequent transfer to plant QC labs.
• Documentation Compliance: Prepare, review, and finalize precise technical documents, including Specifications, STPs, and analytical reports.
• Timely Delivery: Review and submit accurate analytical reports promptly to minimize project lag times.
• Supervisory Oversight (For 4-5 Years Exp): Guide junior analysts, troubleshoot technical issues during analysis, and take responsibility for primary data review.
• Cross-Functional Coordination: Collaborate closely with Formulation R&D, Tech Transfer, and Quality Assurance teams to ensure seamless project progression.

Preferred candidate profile

• Equipment Operation & Calibration: Robust hands-on experience in operating and calibrating high-end instruments like HPLC, Dissolution Testers, UV-VIS Spectrophotometer, and Karl-Fischer (KF) titrators.
• Method Development & Validation: Strong foundational knowledge and practical execution of Analytical Method Development followed by Method Validation.
• Method Transfer: Experience in executing analytical method transfers to Receiving Laboratories (commercial manufacturing sites/QC).
• Compliance & Documentation: Thorough knowledge of Good Laboratory Practices (GLP), data integrity, and strict documentation management systems.
• Review & Reporting: Ability to prepare and review Specifications and Standard Testing Procedures (STP) in compliance with In-house and various Pharmacopoeias.