Manager-MSAT

Roles & Responsibilities
• Support upstream manufacturing processes including data acquisition, monitoring, and trend analysis
• Perform statistical analysis of manufacturing batch data using tools such as Minitab
• Lead troubleshooting activities and process deviation investigations with root cause analysis and CAPA implementation
• Plan, evaluate, and manage technology transfer of new and existing products from R&D to Manufacturing
• Collaborate with R&D teams to execute experimental runs and scale-down studies supporting process improvements
• Plan and implement upstream process changes with cross-functional team alignment
• Conduct risk assessments and prepare validation protocols, validation reports, and facility fit assessments
• Review manufacturing batch records, SOPs, study protocols, study reports, and cleaning validation documents
• Coach, mentor, and train upstream team members to enhance technical capabilities

Qualification
• Master’s degree in Biotechnology or Pharmaceutical Technology
• Doctorate (PhD) in Biotechnology or Pharmaceutical Technology preferred

Experience
• 8–15 years of relevant experience in upstream manufacturing within biotech or pharmaceutical industries

Skills
• Strong expertise in upstream bioprocessing and manufacturing operations
• Hands-on experience with statistical tools and data-driven process optimization
• Knowledge of technology transfer, deviation management, CAPA, and validation activities
• Excellent collaboration and communication skills across cross-functional teams
• Proven leadership and mentoring abilities

About the Organization
Lupin Biotech is a part of the Lupin Group, focused on biopharmaceutical innovation and manufacturing excellence. The organization offers a collaborative environment driven by science, quality, and continuous improvement.