Team member - MSAT

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 manufacturing