An MSAT (Manufacturing Science and Technology) Lead for small molecules bridges pharmaceutical development and commercial production, ensuring chemical manufacturing processes are safe, efficient, and compliant. Core Purpose The MSAT Lead manages the technical lifecycle, technology transfers, process validation, and continuous optimization of Active Pharmaceutical Ingredients (APIs) and small-molecule oral or sterile drug products. Key Responsibilities Process Troubleshooting: Lead complex investigations into manufacturing deviations, identify root causes, and implement corrective actions. Technology Transfer: Manage the scale-up and transfer of chemical synthesis or formulation processes from R&D; to commercial manufacturing sites. CDMO Oversight: Provide technical governance and oversight for external Contract Development and Manufacturing Organizations. Validation & Lifecycle: Author and approve process validation protocols, reports, and continuous process verification plans. Regulatory Support:



Draft and review technical sections for regulatory filings and act as the subject matter expert during health authority audits. Required Qualifications Education: Advanced degree (master’s preferred) in Chemical Engineering, Chemistry, or Pharmacy. Experience: 15 years in pharmaceutical development or technical operations, with a solid background in Good Manufacturing Practices (GMP). Technical Knowledge: Expertise in small-molecule synthesis, crystallization, powder blending, granulation, and analytical data analysis. Detailed JD: 1 Compliance to laboratory procedures. 2 Technology transfer activities for new projects form RND and execution of development and validation batches. Participate in the meeting during the technology transfer and provide solutions to resolve the scalability parameters during the execution. 3 Debottleneck projects for capacity enhancement, process improvements through operational efficiency 4 Listing the Capex requirements along with review with

📌 API MSAT Lead (Telangana)
🏢 Biocon
📍 Telangana