Dr Reddy’s Labs Microbiology Associate Job Opening – Apply Online
Microbiology Associate (CAR-T)
Location: Bengaluru, Karnataka, India
About the Job
Company Description
Dr. Reddy’s Laboratories Ltd. is a leading multinational pharmaceutical company based across global locations. Each of our 24,000+ employees comes to work every day for one collective purpose: to accelerate access to affordable and innovative medicines because Good Health Can’t Wait.
Job Description
We are currently seeking an experienced Microbiologist who can assist in establishing our CAR-T manufacturing GMP facility and managing and supervising production and QC microbiology activities. The ideal candidate should have prior experience in producing biologics and cell therapy products in a cleanroom environment under cGMP regulations.
- Set up the overall microbiology operations of site GMP manufacturing operations and ensure the laboratory performs optimally while complying with all regulatory agencies and aiming for continuous improvement.
- Prepare lab layout, procure and qualify lab equipment, and validate software to meet regulatory standards.
- Prepare and execute microbiology method validation protocols (e.g., sterility, mycoplasma, endotoxin), equipment qualification, CSV, etc.
- Plan and execute clean room qualification, aseptic process simulation qualification, clean room maintenance, and risk assessments as per corporate QMS/regulatory requirements.
- Serve as an internal subject matter expert and support regulatory audits.
- Develop EMP for cleanroom monitoring and ensure sterile operation compliance.
- Perform laboratory investigations such as OOS/OOT/OOL and conduct root cause analysis.
- Prepare SOPs and documents to comply with regulatory requirements.
- Develop a disinfectant program/maintenance strategy for the clean room.
- Implement safe working conditions and practices in the laboratory.
- Support in preparing CAPEX and OPEX budgets for the laboratory and adhere to the budget.
Qualifications
- Master’s or Bachelor’s degree in Biology, Microbiology, Biotechnology with 2–6 years of industrial experience in regulated markets and Cell and Gene Therapy.
- Experience in environmental monitoring and bacterial endotoxin testing.
- Familiarity and understanding of FDA, EU, and local industrial requirements.
- Evidence of a solid background in technical knowledge and experience, plus successful direction of significant projects.
- Ability to work independently and as a member of a team in a dynamic, fast-paced environment is essential.
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Completed Msc Biotechnology
Want job.