Research Associate - Bio Immunoassay

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

) 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