Melanie Antolini

Production Manager, Reagent Manufacturing at Pacific Biosciences
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Contact Information
us****@****om
(386) 825-5501
Location
San Jose, California, United States, US
Languages
  • Spanish -

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Experience

    • United States
    • Biotechnology
    • 400 - 500 Employee
    • Production Manager, Reagent Manufacturing
      • Sep 2017 - Present

      • Oversee production of molecular biology-based commercial reagents and kits. • Review and approve completed batch records for final release. • Create production schedules • Train employees on production processes • Write and revise work instructions. • Work cross functionally with groups (Engineering, Production Planning, Purchasing, Materials & Logistics, Facilities, ERP administrators, Quality) to ensure effective execution of Work Orders and provide recommendations for process and systems improvements where needed •Interface with R&D for new product development and transfer. • Supply reports and metrics, including yearly budgets. •Write IQ/OQ for and integrate incoming equipment to the production floor. •SAP Solutions, Agile, Camstar, Salesforce interfaces. •Exercise working knowledge of cGMP, ISO13485, ISO9001. Show less

    • United States
    • Biotechnology Research
    • 700 & Above Employee
    • Supervisor, Monoclonal Antibody/ Formulation Manufacturing
      • May 2016 - Sep 2017

      *Oversee in-vivo and in-vitro antibody production*Interface with supply chain planners for production and R&D for new antibody development*Coordinate scheduling in Antibody manufacturing and purification*Review and approve completed batch records*Write, review, and edit SOP's and MPI's*Supply monthly financial reports and metrics*Deliver performance reviews *Write and execute IQ/OQ/PQ for incoming or transfer eqipment.*Agile Product Life Cycle Management, QAD, and Master Control interfaces.*Exercise working knowledge of cGMP, ISO, QSR, FDA regulated environment Show less

    • Scientist II, Antibody Research & Development
      • Jun 2014 - May 2016

      •Cell/Tissue Culture•PCR•Virus builds•Transformations•Plamid prep/digestion•IVT•Hybridoma Cell line development •Elisa testing•Fusions•Mouse harvesting •Antibody production•Antibody development •Antibody purification •SDS page protein analysis•HPLC protein analyis•Working in a cGMP, ISO, FDA regulated environment•Leading multiple projects•Immunizing / boosting, analyzing bleeds for response to an antigen

  • Santa Cruz Biotechnology
    • santa cruz, california
    • Research Assistant
      • Aug 2013 - Jun 2014

      •Western blotting •SDS-page •Experimental Design •Analysis of experimental results •Leading teams •Western blotting •SDS-page •Experimental Design •Analysis of experimental results •Leading teams

Education

  • San Jose State University
    Bachelor of Science (BS), Molecular Biology
    2006 - 2013

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