Jonathan Romero Email and Phone Number
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Leading aspects of Late Stage Process Development and Commercialization of Celgene's Biologics product Portfolio. Leading Build and Internalization of early Stage Biologics technology transfer and cGMP operations.Provides leadership and oversight of Technology Development, Product comparability, technology transfer of mammalian-based processess Supports Business process improvement initiatives to improve the operation of the biologics
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Distinguished Scientist, Bioprocess Research And DevelopmentMerckSummit, Nj, Us
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Distinguished Scientist, Bioprocess Research & DevelopmentMerck Jun 2024 - PresentProvides scientific direction and leadership within the Biologics Process Research & Development Organization partnering with the early and late stage Biologics research labs, Enabling Technology Teams, and Manufacturing Divisions.Provide leadership to drive Biologics Technology innovations across All biologics modalities from early phase clinical to Commercial LCM
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Head Of Global Process Technology Service- Manufacturing Sciences & CommercializationBristol Myers Squibb Feb 2023 - Aug 2024Lawrence Township, Nj, UsLead efforts to prioritize global investigations for commercial cell therapy products, Lead the network for key process equipment LCM and identify network Process Initiatives to enhance program reliability and throughput. -
Senior Director - Internal Biologics/Cell Therapy Development & MfgBristol Myers Squibb Jan 2021 - Mar 2023Lawrence Township, Nj, UsResponsible for leading technical and operational oversight of Pilot development, tech-transfer and early phase clinical manufacturing activities for Biologics and Cell therapy Biologics entities for the BMS networkProvide strategic leadership for the operational aspects of the clinical drug substance manufacturing so that a full continuum of services exists to respond to the clinical development needs.
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DirectorCelgene Apr 2016 - Jan 2021Summit, New Jersey, UsLate Stage Biologics Development: and Commercialization of Celgene's Biologics product Portfolio (Luspatercept). Provides leadership and oversight of Technology Development, Product comparability, technology transfer of mammalian-based processesPioneered efforts to establish strategy and execute build and operation design of a new internal FIH cGMP Biologics capabilities at New Jersey location – enabling end-End supply of early phase clinical biologics and Cell therapy reagents -
Senior Cmc LeaderBiogen Jul 2015 - Apr 2016Cambridge, Ma, UsLead a multiple cross-functional, matrix team with overall responsibility for late stage biologics program, process life cycle, change control management, and global regulatory strategy and filings. -
Associate DirectorBiogen Aug 2011 - Jul 2015Cambridge, Ma, UsManage cGMP Process Engineering activities to support Clinical and Commercial Manufacturing. focusing on Cell Culture, Dispensary & Purification Operations. Expert in the process development, scale-up and transfer to Large-Scale Biologics manufacturing or Separation Operations including separation steps(MF, disc-stack Centrifugation, Depth filtration; UF, VF Membrane Adsorbers) and Purification Unit operations
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Senior Engineer IiiBiogen Jan 2008 - Jul 2011Cambridge, Ma, UsResponsibility for Managing and Leading both the Engineering Development and Process Technology and Pilot Groups.Led the strategic introduction of new ‘disruptive’ technologies into downstream purification MFG facilities globally.Led the Development and Technology Transfer to MS/MFG/QA of 8 programs spanning early Phase I to Commercial. Strategically championing Platform Process (AD, CCD, PUR) Strategies for early Phase programs currently being adopted across TD teams for new incoming early phase programsInvolved in Internal Regulatory biannual Inspections (FDA, EMEA, Canada, Brazil, Japan). BIIB CMC representative for Pre-IND mtg discussions w/ FDA
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Senior Engineer I - IiBiogen Sep 2004 - Dec 2007Cambridge, Ma, UsManage the Engineering Purification Development within the Process Biochemistry Department. The position also involves leading the small-scale development of Separation unit operations into for clincal and commercial programsLed the Development of Downstream process train for 6 internal BIIB programsExpert in Membrane separations operations (microfiltration, ultrafiltration, dialysis) using cross-flow (CF) Tangential Flow Filtration (TFF) - lab scale -->Large Scale
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Process Engineer IiiBiogen Aug 2002 - Sep 2004Cambridge, Ma, UsResponsibility for direct Technical Support and Leadership of all Downstream Process Investigations occurring in BioProcess and Purification Unit Operations Manufacturing in Cambridge
Jonathan Romero Skills
Jonathan Romero Education Details
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University Of DelawareChemical Engineering -
Rensselaer Polytechnic InstituteChemical Engineering
Frequently Asked Questions about Jonathan Romero
What company does Jonathan Romero work for?
Jonathan Romero works for Merck
What is Jonathan Romero's role at the current company?
Jonathan Romero's current role is Distinguished Scientist, BioProcess Research and Development.
What is Jonathan Romero's email address?
Jonathan Romero's email address is jo****@****dec.com
What is Jonathan Romero's direct phone number?
Jonathan Romero's direct phone number is +120140*****
What schools did Jonathan Romero attend?
Jonathan Romero attended University Of Delaware, Rensselaer Polytechnic Institute.
What skills is Jonathan Romero known for?
Jonathan Romero has skills like Technology Transfer, Purification, Biotechnology, Gmp, Biopharmaceuticals, Cell Culture, Chromatography, Ultrafiltration, Filtration, Protein Chemistry, Pharmaceutical Industry, Validation.
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