Debjyoti Maiti
M.Pharm in Pharmaceutics & Diploma in Supply Chain Management
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About
Results driven Professional with 14 years plus of extensive experience across FMCG & Pharmaceutical R&D, Technical Transfer, Manufacturing Operations & Quality Management. Proven track record in optimizing factory line efficiency, building robust alternate vendor supply chains and executing risk mitigation plans that prevent supply chain disruptions. Expert at managing product lifecycles from lab-scale procurement to commercial market launch for global markets (WHO, ROW, US, Europe).
Strong cross-functional leader skilled in optimizing departmental inventory, driving down manufacturing waste and coordinating 3rd party contract manufacturing operations to meet tight demand planning timelines.
Experience
Senior Professional - R&D, Technical Transfer, Manufacturing Operations & Quality Management - Dey's Medical Stores (Manufacturing) Limited, Emami Ltd & Ipca Laboratories Ltd
Work experienced in Dey's Medical Stores (Manufacturing) Limited, Emami Ltd & Ipca Laboratories Ltd
- Led cross-functional teams across procurement, compliance, and plant operations to seamlessly transition products from R&D to commercial market delivery.
- Directed alternate vendor development initiatives, reducing material sourcing dependencies for Ayurvedic, Cosmetic, and Pharmaceutical portfolios.
- Manage end-to-end process development, optimization, and scale-up activities to maximize manufacturing line output and minimize batch cycle times.
- Led facility-equipment feasibility studies, gap analyses, and site readiness evaluations to ensure zero-delay transitions during technology transfers.
- Oversee departmental inventory management.
- Supervise 3rd Party Manufacturing coordination, providing technical guidance and operational timelines to external manufacturing partners to on-time delivery of products.
- Established operational Design Space and Critical Control Points (CCPs), eliminating production hazards and reducing batch deviation rates to ensure high product consistency.
- Formulated manufacturing process to significantly lowering out-of-specification (OOS) & material waste.
- Directed pilot-scale and bioequivalence (BE) batch executions targeted for stringent US and European markets under tight supply timelines.
- Managed the authoring, review, and tracking of master operational documents including BMRs, BPRs, and PDRs to standardize production floor workflows.
- Acted as Lead Internal Quality Auditor, enforcing GMP, GDP, and GLP standards to eliminate compliance risks within the warehouse and distribution pipeline.
- Evaluated stability and analytical data to monitor raw material & finished products life cycle management.
Professional - R&D & Manufacturing Operations - Zuventus Healthcare Ltd
Work experienced in Zuventus Healthcare Ltd
- Setup and operational design of a new R&D laboratory facility, ensuring optimal workflow layout.
- Direct end-to-end technology transfer and commercialization logistics, coordinating cross-functional teams (R&D, Production, Engineering, QA, QC, and RA) to transition products from lab to high-volume market delivery.
- Lead heavy-machinery Factory Acceptance Testing (FAT) for critical high-speed lines, including compression, roller compaction, blister packing, and dry powder filling equipment, securing production readiness.
- Establish post-validation commercial process parameters and author comprehensive technology transfer reports to standardize plant workflows.
- Manage departmental procurement and inventory.
Training Professional - Zydus Healthcare Ltd To impart job training to the workmen in order to eliminate errors and get consistency in results.
- On the job training and off the job training of all granulation area machine to all technician along with respective SOPs.
- Handling Pam glatt & ACG top spray & bottom spray granulation.
Professional - Process Development & Manufacturing - Shreya Life Sciences & Plethico Pharmaceuticals
Work experienced in Shreya Life Sciences & Plethico Pharmaceuticals
- Worked on ROW & Domestic market for different dosage form.
- Worked on enzyme & antifungal preparation for CIS country, antimalarial preparation for African country & antihypertensive, multivitamin, Iron preparation for Domestic market.
- Proficiency in process development, scale-ups to commercial production, its standardization as per QBD approach & documentation of all activities.
- Understanding dissolution profiles and various regulatory requirements.
- Preparation of stability protocols as per Standards and monitoring the same as per ICH guidelines.
- Literature search & preformulation study.
- Preparation of Bill of material (BOM), MFR & PDR.
- Exposed to CRO audits of Merck Ltd.
Education
M. Pharm - Pharmaceutics - Gupta College of Technological Sciences (2011)
B. Pharm - M.M.U College of Pharmacy, Ramanagaram (2009)
D. Pharm - Institute of Pharmacy, Kalyani (2005)
Intermediate (10+2) - Champadanga High School (2002)
Matriculation (10th) - Champadanga High School (2000)
