Role & responsibilities
Perform routine and advanced analytical testing of Drug Substances, including ADC drug substances and Amino Acid products.
Support analytical method development, optimization, qualification, transfer, and validation activities.
Execute analytical testing for:
Protein purity and identity
Payload and linker characterization
Drug-to-Antibody Ratio (DAR)
Aggregation and fragmentation analysis
Charge variant analysis
Perform routine analysis, method development, troubleshooting, and validation using HPLC, IC, UPLC, GC, LC-MS, and HRMS.
Support analytical activities related to stability studies, comparability studies, and process changes.
Techniques & Instrumentation
Operate and maintain analytical instruments including:
HPLC/UHPLC (SEC, RP, IEX, HIC)
IC
GC
CE-SDS
UV/Visible Spectrophotometer
LC-MS / LC-MS/MS
HRMS
Capillary Electrophoresis
Perform protein characterization using chromatographic and electrophoretic techniques.
Support peptide mapping, intact mass analysis, and mass spectrometry-based characterization (preferred).
Prepare, qualify,
and maintain reference standards, reagents, and analytical solutions.
Ensure calibration, maintenance, and qualification of laboratory instruments.
Documentation & Compliance
Maintain accurate laboratory documentation, notebooks, and electronic records.
Prepare analytical reports, protocols, validation reports, technical summaries, and investigation reports.
Ensure compliance with GMP, GLP, Data Integrity, and internal SOP requirements.
Participate in deviation investigations, OOS/OOT handling, CAPA implementation, and change control activities.
Support regulatory documentation and audit readiness activities.
Laboratory Safety
Maintain a clean, organized, and secure laboratory work setting.
Follow EHS, laboratory safety, and chemical handling procedures.
Ensure proper storage, labeling, and disposal of chemicals, reagents, and samples.
Adhere to Valuable Laboratory Practices and housekeeping standards at all times
📌 Associate Scientist Adl Pune (India)
🏢 LUPIN
📍 India