Niranjan Bisoi

Pharmaceutical operations leader with 18+ years of expertise in Oral Solid Dosage (OSD) manufacturing, specializing in high-potency oncology and general OSD (tablets, capsules). Skilled in SAP-based material planning, process execution, and end-to-end production lifecycle management including dispensing, granulation, compression, capsule filling, and coating. Proficient in Lean Six Sigma (SMED, KAIZEN, DMAIC, VSM) to optimize yield, reduce variability, and enhance OEE.

Strong track record in global regulatory compliance, audit readiness, CAPA, and change control. Delivered digital transformation initiatives (MES, e-Validation, SAP upgrades) achieving measurable improvements in cycle time, data integrity, and workflow efficiency.

Senior Production Manager (Team Leader, I-2) - Dr. Reddy's Lab, FT07, Leading Pharmaceutical Organizations

(2020-01)

• Directed audit readiness for global agencies, achieving zero major observations.
• Oversaw production planning, scheduling, and workforce allocation across oncology OSD units.
• Led Greenfield project setup and commercialization of regulatory-compliant facilities.
• Championed digital transformation projects (MES, SAP integration, DOCHUB), reducing cycle times by 40% and simplifying processes by 30%.
• Applied Lean tools to improve equipment reliability, reduce downtime, and enhance operational efficiency.
• Conducted risk assessments, managed deviations, and implemented CAPA for continuous improvement.
• Ensured 100% plan vs. actual delivery (RFT, OTIF) with strict compliance to safety and quality standards.
• Mentored and coached teams, fostering collaboration and resolving performance issues.

Production In-Charge – OSD Unit-2 (Executive-5) - Laurus Labs Ltd. - Visakhapatnam

(2015-07 - 2020-03)

Commissioned and stabilized a Greenfield OSD block and scaled operations up to 200+ batches per month, supporting tech transfer and commercial manufacturing of ARV products. Ensured strong compliance execution, supported global audit readiness, improved yield, and reduced variability through parameter-driven process control and operational discipline.

Senior Executive – OSD Manufacturing (Executive-3) - Aurobindo Pharma Ltd. - Hyderabad

(2013-11 - 2015-06)

Managed compression and coating operations for regulated markets, ensuring RFT execution, documentation compliance, and support for validation and process improvement initiatives.

Officer – Production (OSD Manufacturing) - Ipca / Glenmark / Unichem / Lupin ltd.

(2008-01 - 2013-12)

Gained hands-on experience across the complete OSD manufacturing lifecycle, including granulation, compression, coating, and packing, in SAP-based GMP environments.

Bachelor of Pharmacy - Pharmacy - Jeypore College of Pharmacy, BPUT (2002-01 - 2006-01)