Team member - MSAT

Job 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. 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 Description We are seeking a detail-oriented and collaborative Team Member for our Manufacturing Science and Technology (MSAT) department in Pydibimavaram, India. This role is crucial in ensuring smooth execution of various batches, from confirmatory to validation, and supporting process optimization and scale-up activities. Execute and monitor confirmatory, trial, scale-up, exhibit, pre-validation, validation, and placebo batchesDemonstrate successful process scale-up for timely execution of confirmatory, exhibit, pre-validation, and validation batchesPrepare and review essential documents such as Master Formulation Records (MFR), Process Instructions Sheets (PIS), sampling plans, and master production recordsPerform scale-up correlations for all unit operations from lab to plant scaleAnalyze data and provide support in addressing process-related regulatory deficienciesPrepare and review protocols and reports for hold time studies, submission batches, Process Performance Qualification (PPQ), and stability studiesCoordinate with cross-functional teams to ensure timely completion of activitiesConduct investigations, prepare detailed reports, and recommend appropriate corrective and preventive actions (CAPA) for submission and validation batchesPlan and execute trials to identify probable root causes of issuesInitiate change control procedures as required for batch executionSupport cleaning verification and validation activities Qualifications Master's degree in Pharmacy3-7 years of experience in Process Development, Technology Transfer, or MSATProven expertise in process development, scale-up, and technology transfer of solid dosage formsStrong understanding of pharmaceutical process selection and optimizationProficiency in preparing technical protocols and reportsExperience with process engineering and risk assessment approachesIn-depth knowledge of ICH guidelines and other relevant regulatory requirementsFamiliarity with statistical software and data analysis techniquesSolid background in analytical research and data interpretationExcellent communication and interpersonal skillsStrong analytical and problem-solving abilitiesPerformance-oriented mindset with a focus on continuous improvementAbility to work collaboratively within a team and across functionsCommitment to learning and coaching team membersFamiliarity with Good Manufacturing Practices (GMP)Knowledge of regulatory requirements in pharmaceutical manufacturingWillingness to work in Pydibimavaram, India