Department: Manufacturing Science and Technology (MSAT)
Location: Bengaluru
Experience: 12–18 years

Role Purpose

Lead MSAT activities for Oral Solid Dosage products, including technology transfer, scale-up, process validation, commercialization, troubleshooting, continuous process verification, and lifecycle management for regulated markets.

Key Responsibilities

* Lead technology transfer of OSD products from R&D;, other manufacturing sites, or external partners to commercial manufacturing.
* Manage scale-up, exhibit, registration, process performance qualification (PPQ), and commercial validation batches.
* Conduct manufacturing process assessments covering dispensing, blending, wet and dry granulation, fluid-bed processing, compression, coating, capsule filling, and packing.
* Establish critical quality attributes, critical process parameters, material attributes, process controls, and proven acceptable ranges.
* Prepare and review technology-transfer documents, risk assessments, process validation protocols/reports, batch manufacturing records, SOPs, and technical reports.




* Perform equipment and facility-fit assessments and identify requirements for new equipment, modifications, or capacity enhancement.
* Lead troubleshooting of manufacturing deviations, OOS/OOT results, yield losses, process variability, product complaints, and recurring failures.
* Apply structured root-cause analysis and statistical tools such as DOE, trend analysis, FMEA, Minitab, or JMP.
* Develop and implement CAPAs and verify their effectiveness.
* Lead continuous process verification and periodic product/process performance reviews.
* Drive improvements in yield, cycle time, batch size, capacity utilization, right-first-time performance, productivity, and cost of goods.
* Support current product launches, alternate-source qualifications, process changes, raw-material changes, and site-transfer projects.
* Work closely with Formulation R&D;, Manufacturing, Quality Assurance, Quality Control

📌 Lead MSAT OSD (Bengaluru)
🏢 Biocon
📍 Bengaluru