Senior Research Associate - ADL

Kopran; Khopoli; On-site; INR 600,000 - 800,000; Full time

Job summary

Kopran in India seeks a competent Analyst with hands-on experience in analytical method development and stability studies. You will plan and perform analyses on formulation development samples, operate HPLC, UV-VIS, dissolution testers, and Karl Fischer instruments, and ensure timely data delivery.

You will document specifications, STPs, and analytical reports, support method validation and transfer to QC labs, and mentor junior analysts while coordinating with Formulation R&D, Tech Transfer,

Qualifications

• GLP/GxP knowledge and data integrity practices.
• Experience with instrument calibration and maintenance.
• Ability to review and prepare analytical documentation.

Responsibilities

• Plan and execute analysis of formulation development and stability samples.
• Calibrate and operate HPLC, Dissolution, UV-VIS, and KF instruments.
• Develop stable analytical methods, validate them, and transfer to QC labs.
• Prepare, review, and finalize specifications, STPs, and analytical reports.

Skills

HPLC operation

Dissolution testing

UV-Vis spectrophotometry

Karl Fischer (KF)

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.