Team member - Drug Substance

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.

Job summary
We are looking for an individual to execute downstream/upstream MES (E BPR) unit operations, ensuring documentation and compliance within GMP (Good Manufacturing Practices), regulatory, and organizational guidelines. The objective is to produce products within defined volumes and timelines while maintaining compliance with quality standards, GMP, and other regulatory and statutory requirements, as per the schedule.

Roles & Responsibilities
• You will execute unit operations within Upstream according to the BPR (Batch Production Record), conduct activities to support production schedules, obtain and stock supplies as required, prepare media, buffers, and solutions necessary for unit operations, and perform routine cleaning and support activities in GMP Manufacturing areas.
• You will perform routine process area cleaning, autoclave operation, manual cleaning and sterilization of components and parts, monitoring processes and results, suggesting methods to ensure process success, and interfacing with process automation systems.
• You will issue discrepancies, collaborate with cross-functional departments to close them, implement corrective actions, and comply with GMP and safety standards, for designated manufacturing equipment.
• You will complete batch documentation in alignment with GMP, ensuring data collection and maintenance meet cGMPs (Current GMP), company standards, policies, and regulatory requirements, and supporting timely root cause investigations and CAPA (Corrective and Preventive Actions) completion.
• Your other responsibilities include maintaining manufacturing equipment for correct functionality and calibration compliance, operating within validated process parameters, and supporting qualification and validation activities.
• Emphasizing safety awareness and continuous improvement, you will actively adhere to safety rules and promptly report unsafe matters and near misses/accidents.

Educational qualification: A Graduation in Chemical Engineering or Biotechnology, or a Post-Graduation in Science

Minimum work experience: 3 years of experience in working on Biosimilar/Vaccine Products

Skills & attributes:

Technical Skills
• Comprehensive understanding of process manufacturing.
• Expertise in quality systems implementation and adherence to safety norms, ensuring compliance with industry standards.
• Practical experience and hands-on knowledge of Upstream operations.
• Knowledge of equipment and processes, and proficiency in cleaning validation in the pharmaceutical manufacturing context.
• Understanding and knowledge of Clean-in-Place (CIP) and Sterilize-in-Place (SIP) systems.

Behavioral skills
• Possesses effective listening abilities, fostering clear communication and understanding.
• Pays meticulous attention to detail, ensuring precision in tasks and work.
• Prioritizes and is aware of deadlines, ensuring timely completion of tasks.
• Demonstrates analytical skills and the ability to troubleshoot effectively.
• Possesses strong interpersonal skills and collaborates effectively within a team.

About the Department
Biologics
Currently operates in the Global Biosimilars business - a segment that is poised for attractive and sustained growth over the next 10–15-year time horizon.
With a robust portfolio of biosimilar products across key therapeutic areas, covering ~US$80+ Bn in innovator sales – future business pipeline covers a variety of product classes and therapy areas, and new modalities. Fully integrated organization with over two decades of experience in developing, manufacturing and commercializing multiple biosimilar products.
With a Product Development engine that has end-to-end capabilities – in-house clone development, upstream and downstream process development, bioanalytical development and proprietary formulation.
Supported by a Clinical and Regulatory team with experience in executing complex biosimilar programs with innovative global trial designs.
We have a proven experience in commercial-scale manufacturing across a variety of technology platforms with global quality standards and a highly competitive cost structure
Rich experience of commercializing high-quality biosimilars in multiple markets with over 900,000 patients having benefited from our products till date.

Benefits Offered
At Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs.
The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself.

Our Work Culture
Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic.
For more details, please visit our career website at https://careers.drreddys.com/#!/