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.
- Robust 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.

📌 Lead MSAT OSD (Bengaluru)
🏢 Biocon
📍 Bengaluru