Team Lead - Drug Substance (Downstream)

Job summary

We are seeking an individual to lead the downstream manufacturing team and oversee the implementation of production schedules. The objective of this role is to produce products within defined volumes and timelines, ensuring compliance with quality standards, GMP (Good Manufacturing Practices), and other regulatory and statutory requirements, as per the schedule.

Roles & Responsibilities

• You will receive inputs from production planning, oversee daily operations on the production floor (including scheduling, staffing, monitoring, training, and troubleshooting), ensure compliance with applicable BPRs/EBRs (Batch Production Record/Electronic Batch Record ), SOPs (Standard Operating Procedures) and safety guidelines, and administer contract manpower.

• Your responsibilities include issuing discrepancies, collaborating with cross-functional departments to close discrepancies, implementing corrective actions, adhering to GMP, safety standards, and SOPs for designated manufacturing equipment, and completing batch documentation in compliance with GMP.

• You will maintain manufacturing equipment functionality and calibration compliance, operate equipment within validated process parameters, actively promote safety awareness and improvements, engage in continuous improvement activities, and report unsafe matters and near misses/accidents.

• You will actively promote safety awareness and improvements, be involved in goal setting and performance reviews, providing training and coaching to employees, effectively manage employee performance issues and corrective actions, and recognize employee contributions.

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

Minimum work experience: 12 years of experience in working on Biosimilar Products

Skills & attributes:

Technical Skills

• Comprehensive understanding of process manufacturing.

• Understanding of Quality Systems and the regulatory environment, with the ability to integrate quality standards into manufacturing processes.

• In-depth knowledge of Current Good Manufacturing Practices (cGMP) and safety regulations.

• Knowledge in mammalian cell culture techniques.

• Expertise in operating bioreactors, proficiency in using control systems, familiarity with data acquisition and storage systems.

Behavioural 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/#!/