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 environment.
- Follow EHS, laboratory safety, and chemical handling procedures.
- Ensure proper storage, labeling, and disposal of chemicals, reagents, and samples.
- Adhere to Good Laboratory Practices and housekeeping standards at all times

📌 Associate Scientist - ADL (Pune)
🏢 LUPIN
📍 Pune