Job Responsibilities: A) Project Management Undertake on-going referencing and literature reviews and provide strategic inputs to projects at all stages Evaluate methods under consideration by conducting literature survey (incl. regulatory guidelines, pharmacopeia guidelines, publicly available research, etc.) Identify initial cell-lines/ anti-body requirement based on method(s) identified Conduct lab experiments for bio-assay/ immuno-assay development and optimization Conduct lab experiments to qualify the method for reproducibility Prepare/provide inputs for the preparation of necessary documents like Method development report, Method qualification protocol and report. Method validation protocol and report, Standard Analytical Procedures (SAP), Method transfer protocol and report. Ensure tech-transfer by demonstrating process to plant operators (in lab premises) Observe process in plant and resolve any queries that may arise (post-transfer) B) Bio-assay/Impurity assay (HCP and HCDNA) /Binding ELISA assay/SPR assay/BET Method development, qualification and transfer Conduct regular analysis for non-GMP and non- release batches (not transferred to plant) - support other labs by stability testing samples provided by them Prepare and share detailed reports with the relevant labs upon completion of the tests Conduct Bioassay, HCP, HCDNA, Protein A ELISA, SPR, Binding assay and BET method development/qualification and routine analysis (C) Other tests and routine processes Conduct / guide RAs for conduct of regular analysis for non-GMP and non-release batches (not transferred to plant) - Support other labs by stability testing samples provided by them tests as requested. Prepare/review and share detailed reports with the relevant labs upon completion of the tests Conduct/ guide RAs for conduct of method development/qualification and routine analysis Review protocols and reports provided by CRO (based on expertise) Coordinate CRO with ADA assays, Antibody generation, purification and biotinylating activity for in-house HCP method. (D) Materials and equipment management Procure and maintain inventory of cell-lines/anti-bodies/ consumables/ equipment: Share details of requirements with purchase team Engage in technical discussions with vendors to identify and recommend suitable ones to lab head and Supply Chain Raise PR for purchase Oversee Check materials upon receipt and store them as per set-norms (freeze in case of cell-lines) Track and maintain inventory in order to control and manage short-falls and damage Maintain inventory-logs and intimate superiors in case of short-falls and damage Manage cell-culturing and sub-culturing process: Prepare cell-banks (by freezing cell-lines) for storage Passage cells (remove vials from these banks) as per testing need Calibrate select lab-equipment on regular basis to facilitate use Ensure scheduled and break-down maintenance by coordinating with vendors/ maintenance team ( E) Regulatory and compliance Accurately capture all lab experiments in raw- data and lab-notebooks (incl. electronic data- capture) in real-time on an on-going basis. Adhere to regulatory, SOPs and safety guidelines for all processes. Ensure timely closure of regulatory queries by conducting and documenting lab experiments. Ensure data integrity in all respects Compile and Review all project-related documents created during lab activity on a regular basis Prepare/ modify SOPs by gauging work ability of the processes/practices in timely manner (F ) Business (people & budgets) planning, continuity and improvement Conduct SOP and induction trainings for subordinates Provide timely and relevant inputs for the preparation of capex budget Identify and implement continuous improvement initiatives to enhance process efficiency Take initiative to provide time and inputs (based on expertise/interest) to other on-going projects (G) Learning and improvement Attend all mandatory trainings Take initiative to provide inputs (based on expertise/interest) to other on-going projects Take initiatives for self-development and update self on recent developments in own area of work Take initiative to train fresh RAs upon induction or guide them with select lab processes (basis expertise) (F) Quality Compliance Initiate change control for New instrument IQ/OQ/PQ/CSV of new instrument. GDP Compliance Compliance related to internal and external audits