Analytical Method Development Scientist | GLP/GDP Lab

Lupin Ltd; Indiana; On-site; USD 60,000 - 80,000; Full time

Job summary

Lupin Ltd in the United States is seeking a skilled analytical chemist to develop analytical methods for drug products, including assay, dissolution, and degradation studies using HPLC, GC, UV, and KF techniques.

You will document workflows in BIOVIA, ensure data integrity and traceability, and prepare method development protocols, reports, COAs, and GLP/GDP-compliant records while maintaining safety standards.

Qualifications

• Masters in Pharmacy or Analytical Chemistry required.
• Experience in analytical method development preferred.
• Knowledge of GLP and data integrity a plus.

Responsibilities

• Develop analytical methods for drug products (assay, dissolution, degradation, residual solvents, water content) using HPLC/GC/UV/KF.
• Document workflows in BIOVIA ensuring data integrity, traceability, audit trail compliance, and secure electronic record management.

Skills

Analytical method development

Quality systems awareness

Education

Master's in Pharmacy or Analytical Chemistry

Tools

HPLC

GC

UV

Karl Fischer (KF)

Job description

Lupin Ltd in the United States is seeking a skilled analytical chemist to develop analytical methods for drug products, including assay, dissolution, and degradation studies using HPLC, GC, UV, and KF techniques.

You will document workflows in BIOVIA, ensure data integrity and traceability, and prepare method development protocols, reports, COAs, and GLP/GDP-compliant records while maintaining safety standards.