Specialist - Process MSAT

Company Description

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
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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 seeking a dynamic and experienced Team Lead in Process Development to lead and guide the Injectable Process development team in areas of Quality by Design (QbD), Process selection, Scale Up and Technology transfer to Manufacturing, Science & Technologies (MSAT)/ Formulation Technology Organisation (FTO)/ Contract Manufacturing Organisation (CMO) and ensure product development leads to development of robust manufacturing process throughout the clinical phases and commercial product life cycle.

• Prepare, review, and approve technical protocols, reports, SOPs, and product impact assessments related to product lifecycle management (LCM).
• Initiate, review, and approve change controls, incidents, and risk assessments related to validation and qualification activities.
• Coordinate with cross-functional teams (Production, QA, QC) for execution and documentation of new products, scale-ups, and transfers.
• Lead technology transfer activities for new products, scale-ups, line transfers, and site-to-site commercial batches for injectable products.
• Support investigations for non-conformances (Incidents, OOS, OOT, Market Complaints) through root cause analysis and impact assessments.
• Provide technical support for process changes and improvements along with addressing regulatory deficiencies and support audits to ensure timely product approvals.
• Serve as a technical expert to resolve domain-specific issues and contribute to organizational problem-solving.
• Review Continued Process Verification (CPV) assessments and Product Quality Reports (PQRs).

Prepare and review cleaning validation documents including protocols, reports, master plans, and assessments.

• Provide technical support to the analytical team in designing and reviewing analytical methods for quality and compliance.
• Evaluate and introduce new analytical technologies to resolve technical issues, perform proof of concept, and support HPT initiatives.

Serve as the subject matter expert for fill-finish processes, ensuring robust and compliant operations.

Educational…