Lead MSAT OSD

Biocon; Bengaluru; On-site; INR 4,000,000 - 7,000,000; Full time

Job summary

Biocon in Bengaluru seeks an experienced MSAT Leader to drive technology transfer, scale-up, validation, and lifecycle management for Oral Solid Dosage products in regulated markets.

You will mentor the MSAT team, coordinate with QA, Regulatory, and Manufacturing, and deliver on KPIs like yield, cycle time, and successful PPQ campaigns.

Qualifications

• B.Pharm or M.Pharm with specialization in Pharmaceutics or Pharmaceutical Technology.
• 12–18 years of pharma experience with OSD, MSAT, technology transfer, scale-up or process validation.
• Strong experience with tablets and capsules, including IR and modified-release products.
• Demonstrated experience transferring and commercializing products for regulated markets.
• Sound knowledge of cGMP, data integrity, ICH Q8/Q9/Q10, Quality by Design, and CAPA systems.
• Strong understanding of formulation–process–equipment interactions and scale-up principles.
• Experience handling multiple projects with cross-functional, multi-site teams.
• Good leadership, stakeholder-management, documentation, presentation, and communication skills.

Responsibilities

• Lead technology transfer of OSD products from R&D, other sites, or partners to commercial manufacturing.
• Manage scale-up, exhibit, registration, PPQ, and commercial validation batches.
• Conduct manufacturing process assessments across dispensing, blending, granulation, coating, compression, filling, and packing.
• Establish critical quality attributes, CPPs, material attributes, process controls, and RO ranges.
• Prepare and review tech-transfer docs, risk assessments, validation protocols/reports, batch records, SOPs, and reports.
• Perform equipment and facility-fit assessments and identify requirements for new equipment or capacity.
• Lead troubleshooting of deviations, OOS/OOT, yield losses, and process variability.
• Apply root-cause analysis and statistical tools (DOE, trend analysis, FMEA, Minitab, JMP).
• Develop and implement CAPAs and verify effectiveness.
• Lead continuous process verification and periodic performance reviews.
• Drive improvements in yield, cycle time, capacity utilization, and cost of goods.
• Support new product launches, alternate-source qualifications, process changes, and site transfers.
• Work with Formulation R&D, Manufacturing, QA, QC, Regulatory, Engineering, Supply Chain, and EHS.
• Provide technical support during regulatory submissions, audits, and inspections by USFDA, EMA, MHRA.
• Mentor MSAT team members and strengthen problem-solving capabilities.

Skills

Technology transfer

Scale-up

Process validation

cGMP knowledge

Data integrity

DOE analysis

Quality by Design

Cross-functional leadership

Education

B.Pharm or M.Pharm

Tools

Minitab

JMP

Job description

Department: Manufacturing Science and Technology (MSAT)

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.