Dhananjay Tripathi
Medical Devices Professional || Plant Head || Lead Auditor || Lean Six Sigma Black Belt ||
- Role
- Factory Manager at Nextgen In-Vitro Diagnostics Pvt. Ltd
- Location
- Gurugram, HR, IN
- LinkedIn followers
- 500 followers
About Dhananjay Tripathi
14+ years’ experience in In-vitro Diagnostic (IVD) medical devices.• Strong technical knowledge across Molecular Diagnostics, FIA, ELISA, Rapid Tests, Biochemistry, Serology & Haematology.• Expertise in turnkey projects, factory setup, project management, technology transfer, scale-up & process improvement.• Experienced in handling Plant P&L, Capex and Opex planning, budgeting, and optimisation.• FDA-approved QC Chemist with multi-domain experience in QC, QA, Regulatory, Manufacturing, PPIC, & Supply Chain.• Subject Matter Expert (SME) for MDR 2017, IVDR, WHO PQ, certifications, factory compliance & manufacturing licenses.• Certified Lead Auditor for ISO 13485 & ISO 9001; Six Sigma Black Belt certified.• Excellent communication, problem-solving, interpersonal & team-building capabilities.• Quick learner with strong ability to grasp and apply new concepts effectively.
Experience
Factory Manager
Nextgen In-Vitro Diagnostics Pvt. Ltd
Nov 2023 — Present · Gurugram, IN
Providing strategic leadership for in-vitro diagnostics manufacturing plant, with full accountability for operations, quality systems, regulatory compliance and P&L performance. Oversee operational excellence, audit readiness, risk management, and continuous improvement and aligning plant strategy with business objectives.
Education
Gautam Buddha University
Master of Technology (M.Tech.), Biotechnology (Genetic Engineering)
2012
Skills
- Rna Isolation
- Technology Transfer
- Genomics
- Life Sciences
- Cell
- Western Blotting
- Drug Discovery
- Cell Culture
- Bioinformatics
- U.s. Food and Drug Administration (Fda)
- Lifesciences
- Purification
- Microscopy
- Validation
- Biochemistry
- Hplc
- Chromatography
- Cell Biology
- R&D
- Microbiology
- Dna
- Dna Extraction
- Research
- Biotechnology
- Protein Purification
- Research and Development (R&D)
- Sds-Page
- Immunoassays
- Protein Chemistry
- Genetics
- Proteomics
- Immunodiagnostics
- Medical Devices
- Hematology
- Gel Electrophoresis
- Pcr
- Qpcr
- Molecular Biology
- Rapid Card Test
- Rt-Pcr
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