Dhananjay Kapale

Manager Msat @Lonza

Slough, GB
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Jan 2023 — Present

Manager Msat @Lonza

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Slough, GB

EDUCATION

1997 — 2001

Y.B. Chavan College of Pharmacy

B. Pharm, Pharmacy (Bachelor degree)

2001 — 2003

U.D.C.T. Mumbai

M. Tech, Bioprocess Technology

SKILLS

ValidationBiotechnologyProtein PurificationTechnology TransferRegulatory RequirementsCapaManufacturing21 Cfr Part 11MicrobiologyDownstream ProcessingProtein ChemistryHplcMonoclonal AntibodiesUv/VisChromatographyAndaQuality SystemV&VProcess SimulationChange ControlCellCell CultureAseptic ProcessingFermentationGlpAnalytical ChemistryBiopharmaceuticalsGmpLimsVaccinesPharmaceuticsDrug DiscoveryFiltrationPharmaceutical IndustrySopFdaGeneric ProgrammingCleaning ValidationRegulatory AffairsLifesciences

ABOUT DHANANJAY KAPALE

Currently working as Manager - MSAT at Lonza Biologics, United Kingdom. Lean Six Sigma Green Belt Certified.My previous assignment was Deputy General Manager - Mammalian Manufacturing & Fill Finish at Lupin Pharmaceuticals, Biotech Division, Pune, India. Worked in companies like Dr. Reddy\'s Laboratories and Wockhardt Pharmaceuticals in the past.21 years of development and bio-manufacturing experience of mammalian and microbial productsM. Tech. Bioprocess Technology from ICT (UDCT), Mumbai, Bachelor of Pharmacy.Focus areas- MSAT Manager CDMO Business focusing on customer technology transfer, GMP process support- Upstream process development & Scale-up – cell culture & bacterial cultures - Clinical and Commercial manufacturing of DS – Upstream and downstream tech-transfer, cGMP integration, manufacturing operations and execution excellence-Clinical and Commercial manufacturing of DP – Formulation and fill finish tech-transfer (in-house and CMO), cGMP integration, Fill finish operations which includes formulation, filling and packaging operations- Plant Process Engineering (projects) – plant capacity sizing & capacity expansion, concept & detailed design, cost analysis, commissioning, qualification and validation (Greenfield projects of DS and DP manufacturing)- Manufacturing Science and Technology to carry out technology transfer to internal and external customers, GMP Process Support.

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Dhananjay Kapale — Manager Msat at Lonza in Slough, GB | Unifers