Associate Scientist - ADL

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 safe 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