Microbiology Specialist (CAR-T)

Dr. Reddy’s Laboratories Ltd. is a leading multinational pharmaceutical company based across global locations. Each of our 24,000 plus employees comes to work every day for one collective purpose: to accelerate access to affordable and innovative medicines because Good Health Can’t Wait.
We started in 1984 with a modest investment, 20 employees and a bold vision. Today, we have research and development centres, manufacturing facilities or a commercial presence in 66 countries. 
For nearly four decades, we have stood for access, affordability and innovation based on the bedrock of deep science, progressive people practices and robust corporate governance. As the pharmaceutical industry evolves and undergoes disruption, we see an opportunity – to strengthen our core further (the next steps) and to build the future (the new bets).
‘The Next and the New’ is how we aim to continue to be the partner of choice – purpose-driven, future-ready and sustainable.  Our aim is to reach over 1.5 Bn+ patients across the world by 2030 by growing our core businesses and building for the future with sustainability at the core of our purpose and strategy. Sustainability for us means operating in a manner that respects people, planet and purpose – helping us conserve precious resources, serve our patients, create value for stakeholders, give back to society, fulfil our potential and maintain our integrity and transparency
Dr Reddy’s maintains a work environment, free from discrimination and is an equal opportunity employer. We are committed to employ & nurture all qualified diverse workforce without regard to race, colour religion, nationality, sex, age, disability status, genetics, sexual orientation, gender expression, citizenship or any other characteristic or classification protected by applicable law(s) of the country we operate in. We treasure every talent, and recognize merit and diversity in our organization.

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, as well as ensure that the laboratory is performing to its best and in compliance with all regulatory agencies while aiming towards continuous improvement.
• Responsible for preparing lab layout, procuring and qualifying lab equipment, and validating software to comply with 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, etc.
• Serve as an Internal subject matter expert and support regulatory audits.
• To develop EMP for cleanroom monitoring and ensure sterile operation compliance.
• Perform laboratory investigations 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 a laboratory. 
• To support in preparing CAPEX and OPEX budget of the laboratory and adhere to the budget

• Master's degree or bachelor’s degree in biology, Microbiology, Biotechnology with 6 - 10 years of industrial experience in regulated markets and Cell and Gene Therapy.
• Experience of environmental monitoring and bacterial endotoxin testing
• Familiarity and understanding of FDA, EU, and local industrial requirements.
• Evidence of an acquired solid background of technical knowledge and experience, plus successful direction of significant projects
• An ability to work independently as well as a member of a team in a dynamic, fast-paced environment is essential