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.