Amar Dhule
Fermentation & Purification process development/ scale up / Tech transfer/ MSAT/ CMC support / Global Business Development (PI industries| Ex.Alteogen.inc|Ex.Biocon)
- Role
- Group Leader (Dgm) - Bioprocess Development & Commercialisation at PI Industries Ltd
- Location
- Udaipur, RJ, IN
- LinkedIn followers
- 500 followers
About Amar Dhule
PROCESS DEVELOPMENT: Group lead for upstream & Downstream process development Product: Biologics,Peptides, Small Molecules, Enzymes,ADCs & Therapeutic Proteins. Batch & Fed batch fermentation process development at 2 L, 10L, 30L & 500 L scales Application of DOE for optimization of media components & process parameters Optimization of feeding strategies based on the metabolites analysis Fermentation yield improvement. Additional experience on Adsorption, chromatography & Aqueous DownstreamPROCESS SCALE UP/MSAT: Fermentation process scale up: 10L→30L→500L→10 kl →30 kl & 100 kl Chromatography RP, Column Chromatography,(IEX) scale up: Column Diameter 10 mm→100 mm→800 mm column.PRODUCT LIFE CYCLE MANAGEMENT AND MANUFACTURING SUPPORT: Fermentation yield improvement for COGM reduction Media & filtration cost reduction Centrifugation and filtration recovery improvement Batch failure and OOS rate reduction Process time reduction by bottlenecking the critical steps Process validations & cleaning validations Equipment URS review & qualification support Facility expansion & Technology transfer support cGMP Experiences Experimental and validation batches at GMP plants Deviations investigation, root cause analysis, CCF & CAPA implementations Audit support (WHO, KFDA, PMDA, MHRA & US-FDA) Quality risk reduction and compliance improvementPROJECTS: Lead for yield improvement projects Key project member for several projects Team lead for many cross functional activities Exposure on project management tools Team budget preparation, long range planning & projectionsCMC: CMC support for all kind of Regulatory Activities. DMF preparations & Submission RND support for Regulatory queriesGlobal Business Development: Head for Asia & Latin America Business development Proposal preparations, one to one discussions & On-site visit / audit for CMO, CDMO plants. Decision making in Critical Bottle neck discussions. End to end support with Clients.
Experience
Group Leader (Dgm) - Bioprocess Development & Commercialisation
Feb 2023 — Present · Udaipur, IN
Education
Rajarshi Shahu Mahavidyalaya (Autonomous), Latur
Master of Science (M.Sc.), Biotechnology
2006 — 2008
Rajarshi Shahu Mahavidyalaya (Autonomous), Latur
Bachlor of science, chemistry,analytical chemistry & microbilogy
2003 — 2006
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