Head Drug Substance Operations , MSAT , Planning & Transformation

About Biologics

At Dr. Reddys we constantly strive to bring the most advanced medicines within the reach of millions around the world. The efforts at our Biologics division working on high quality global biosimilars for the last twenty years are a testament to that commitment.

Our decades-long experience in the generics business coupled with our world-class capabilities and best-in-class team allow us to create high quality equally effective but significantly more affordable generic biosimilars.

Our product development capabilities and our global reach have quickly made us a leader in this relatively small but fast-growing biosimilars segment. Dr. Reddys Laboratories leads the industry with 6 biosimilar products marketed in several countries and with an extensive development pipeline.

The biosimilar business is pegged to grow by 8X n the next 3-4  years. There is a significant ask on scale and this role will be critical to setting up and driving the transformation and scale up agenda for the Biologics organization to be able to cater to the following asks

• Scale up capacity to address 8X increase of demand through Opex and productivity interventions
• Ensure facility readiness to serve regulated markets
• Digitize the core  and implement Digital 4.0 in operations
• Streamlining Production Planning & Scheduling to provide unconstrained service to front end markets (OTIF-100%)
• Capacity augmentation by new facility set up and acquisition
• Strengthen the MSAT & ASAT organizations to scale to 10X manufacturing outpu

We are seeking an experienced and dynamic Manufacturing Head to lead our biosimilars drug substance manufacturing manufacturing services and technology teams. The ideal candidate will have a strong background in biologics manufacturing with a focus on biosimilars and a proven track record of managing large-scale manufacturing operations.

Qualifications :

In this role you will be responsible for:

•  Conduct a comprehensive evaluation of the organizations preparedness for scaling operations.
•   Design a strategic roadmap for expansion focusing on capacity capability technology and infrastructure development.
•  Lead cross-functional teams in executing transformation initiatives effectively.
•  Strengthen manufacturing and R&D capabilities to support biosimilar scale-up ensuring timely product delivery and audit compliance.
•  Drive the adoption of innovative technologies and process enhancements to optimize performance at scale.
•  Track project milestones analyze key performance indicators (KPIs) and ensure progress aligns with objectives.
•  Implement change management strategies to enable seamless transitions to new processes and systems.
• Leverage data analytics and insights to improve decision-making streamline operations and enhance overall efficiency.
•  Identify evaluate and mitigate risks to ensure business continuity while maintaining regulatory compliance.
• Oversee all aspects of biosimilars drug substance manufacturing ensuring compliance with GMP and regulatory standards.
• Lead and manage the manufacturing services and technology teams to optimize production processes and improve efficiency.
• Develop and implement manufacturing strategies to meet production goals and timelines.
• Drive transformation initiatives to enable scale-up to 8X achieving best-in-class productivity.
• Ensure all manufacturing plants are audit-ready and capable of supplying products without constraints.
• Ensure the highest standards of quality control and assurance throughout the manufacturing process.
• Collaborate with cross-functional teams including R&D Quality and Regulatory Affairs to support product development and commercialization.
• Drive continuous improvement initiatives to enhance manufacturing capabilities and reduce costs.
• Manage the technology transfer process for new products and processes.
• Ensure compliance with all safety health and environmental regulations.
• Develop and manage the manufacturing budget including capital expenditures and operational costs.
• Mentor and develop team members fostering a culture of innovation and excellence.
• Develop the scale up transformation roadmap with respect to capacity capability technology and infrastructure. Introduce new technologies and process improvements that will significantly scale the performance

Qualifications Experience Skills & Attributes

• Bachelors degree in Biochemistry Biotechnology Chemical Engineering or a related field. Advanced degree preferred.
• Minimum of 15 years of experience in biologics manufacturing with at least 5 years in a leadership role
• Extensive knowledge of biosimilars manufacturing processes including upstream and downstream processing.
• Strong understanding of GMP regulatory requirements and quality control standards

Experiences:

• Proven experience in managing large-scale manufacturing operations and leading cross-functional teams
• Track record of clearing FDA audits and scaling manufacturing operations
• Past experience in introducing new technologies and interventions for improving performance
• Experience of leading teams 400
• Experience with single-use bioreactor technology and continuous manufacturing processes.
• Knowledge of process development and technology transfer.
• Familiarity with regulatory submissions and inspections.

Remote Work :

No

Employment Type :

Full-time