Team member - Drug Substance

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.

Qualifications :

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.

Additional Information :

About the Department
Biologics
Currently operates in the Global Biosimilars business - a segment that is poised for attractive and sustained growth over the next 1015-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 900000 patients having benefited from our products till date.

Benefits Offered
At Dr. Reddys we actively help to catalyse your career growth and professional development through personalised learning programs.
The benefits you will enjoy at Dr. Reddys 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. Reddys why they come to work every day and theyll say because Good Health Cant 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 were 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

Remote Work :

No

Employment Type :

Full-time