Research Associate
2 days ago
Job description - Research Associate (Protein Chemistry laboratory)
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
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
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
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)
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
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