Melanie Antolini
Production Manager, Reagent Manufacturing at Pacific Biosciences- Claim this Profile
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Bio
Experience
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PacBio
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United States
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Biotechnology
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400 - 500 Employee
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Production Manager, Reagent Manufacturing
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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
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Thermo Fisher Scientific
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United States
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Biotechnology Research
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700 & Above Employee
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Supervisor, Monoclonal Antibody/ Formulation Manufacturing
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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
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Scientist II, Antibody Research & Development
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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
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Santa Cruz Biotechnology
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santa cruz, california
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Research Assistant
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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
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Education
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San Jose State University
Bachelor of Science (BS), Molecular Biology