Lead MSAT OSD

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 new 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, Regulatory Affairs, Engineering, Supply Chain, and EHS.
* Provide technical support during regulatory submissions, customer audits, and inspections by USFDA, EMA, MHRA, and other regulatory agencies.
* Mentor MSAT team members and strengthen technical problem-solving capabilities across manufacturing operations.
Candidate Profile
* B.Pharm or M.Pharm, preferably with specialization in Pharmaceutics or Pharmaceutical Technology.
* 12–18 years of pharmaceutical experience, with significant exposure to OSD manufacturing, MSAT, technology transfer, scale-up, or process validation.
* Strong experience with tablets and capsules, including immediate-release and modified-release products.
* Demonstrated experience in transferring and commercializing products for regulated markets.
* Sound knowledge of cGMP, data integrity, ICH Q8/Q9/Q10, Quality by Design, process validation, change control, deviation investigation, and CAPA systems.
* Strong understanding of formulation–process–equipment interactions and scale-up principles.
* Experience handling multiple projects and working with cross-functional and multi-site teams.
* Good leadership, stakeholder-management, documentation, presentation, and communication skills.
Preferred Experience
* Successful execution of multiple product transfers, PPQ campaigns, and commercial launches.
* Exposure to high-potent products, containment systems, or complex/modified-release formulations.
* Knowledge of statistical process control, Lean Six Sigma, Minitab, or JMP.
* Experience supporting regulatory inspections and responding to technical regulatory queries.
* Previous responsibility for managing or mentoring an MSAT or technology-transfer team.
Key Performance Indicators
* On-time completion of technology-transfer and validation projects.
* Right-first-time success of scale-up and PPQ batches.
* Reduction in deviations, process variability, cycle time, and manufacturing cost.
* Improvement in yield, productivity, capacity utilization, and process robustness.
* Timely closure and effectiveness of investigations and CAPAs.
* Successful regulatory inspections and commercial product launches.

Work arrangement
No