Research Associate - Protein Purification

Job description - Research Associate (Protein Chemistry laboratory)

1. Process development, scale-up and transfer: (Downstream) 

• Undertake on-going referencing and literature reviews and provide strategic inputs to projects at all stages

• Conduct lab experiments as per the shortlisted methodologies in order to develop & finalize purification processes for various recombinant therapeutic products. Provide own inputs and insights to optimize/improve process

• Provide samples to analytical labs for testing, collect and file reports of analysis, compile the data and do data analysis for conclusion of experiments

• Support plant activities as per need

• Present data in project review meetings

• Prepare process development report and technology transfer documents

• Participate in at-scale demo batches and handover as part of technology transfer

• Jointly monitor purification process at production facility and resolve any queries that may arise during production

2. Materials and equipment management:

• Oversee installation of new equipment and attend demos

• Maintain all IQ/OQ/PQ documents

• Ensure scheduled and breakdown maintenance by coordinating with maintenance team

• Create and maintain all maintenance/ repair logs

• Support management of chemical, consumables:

o Transfer/store as per set norms

o Engage in technical discussions with vendors in order to suggest suitable vendors

o Maintain material logs and calculate shortfalls (for order placement)

o Post materials required onto SAP

3. Regulatory and compliance:

• Accurately capture all lab experiments in laboratory notebooks in real-time

• Adhere to regulatory, SOPs and safety guidelines for all processes

• Modify SOPs in own area of work

• Ensure timely closure of regulatory queries by conducting and documenting lab experiments

• Ensure data integrity in all respects

4. 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)

5. Compliance management

• Ensuring GDP compliance

• Ensuring CC/ IQ/OQ/PQ/CSV of new instrument

• Ensuring calibration/PM/AMC of equipment

• Be audit ready and prepare audit responses as per audit points
• Lab cleanliness, lab maintenance