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.
