Brandon Pastore

Experience

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  Bayer Corporation

  Jan 1998 - Jan 1998

  Chemistry Intern

  Prepared polymer samples for analytical testing utilizing wet ashing and Parr aparatus techniques. In addition, performed analyses using capillary electrophoresis, inductively coupled plasma and flame atomic absorption methodologies. Furthermore, developed methods for analyzing carbonyl compounds and amines using the capillary electrophoresis instrument.

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  Pharmacia Corporation

  Jan 1999 - Jan 2002

  Assistant Scientist

  Analyzed a variety of line-extension and early exploratory drug candidates using HPLC, Karl Fischer, and atomic absorption methodologies while acting as the unit IQ/OQ coordinator, Change Control Request Project Leader, and Karl Fischer specialist. In addition, developed/validated methods for Karl Fischer titrations and atomic absorption trace metal analysis as well as implemented transfer methods for HPLC.Special Projects Act as a consultant to the Analytical Development labs on the qualification of instrumentation for the GMP environmentLed a team that designed the equipment installation and operation qualification process Show less

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  2005 Pfizer Corporation

  Jan 2002 - Jan 2005

  Method Development/Validation Chemist

  Develop and validate HPLC, AA, GC/MS methods on a variety of line-extension and early exploratory drug candidates. In addition, act as a consultant to the Pharmaceutical Sciences R&D division on laboratory equipment qualifications as well as act as a consultant to the Support Laboratory areas on Karl Fischer titrations.Special Projects Led a team that developed and implemented an automated gradient pump calibration programCo-Lead a team that developed and implemented a harmonized training program for AR&DProvide regulatory assistance to the R&D laboratories to establish and maintain compliance Show less

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  Bausch and Lomb (Global R&D)

  Jan 2006 - Aug 2006

  Method Development/Validation Chemist (Research Scientist)

  Develop, validate and transfer HPLC methods for a variety of medical device products and pharmaceutical candidates. Represent the role of Analytical Development on various project teams to ensure appropriate testing and analysis of results to support team decisions. Special Projects Led a team that developed a training program for Analytical DevelopmentAct as the project team leader for the movement of analytical development labs to a new R&D facilityDeveloped a high throughput potency screening method for early phase formulations on a micro-plate reader and implement this technique as an orthogonal method to HPLC. Show less

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  Lomb (Global R&D)

  Aug 2006 - Jun 2008

  Co-Manager of Analytical Lab Operations (Research Scientist)

  Co-lead the Analytical Laboratory Operations group and perform a GAP analysis/Remediation with respect to lab compliance. Act as project leader of teams created to perform remediation in key areas in need of improvement with respect to established FDA guidelines for pharmaceutical analyses. Implement the enhancements produced by the aforementioned project teams. Special Projects Develop and implement an upgraded Training Program for Global R&D to support Bausch and Lomb's internal Quality DirectivesDesign, establish, and maintain the clinical trial materials process and testing to support speed of execution for the R&D supply chain Show less

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  Bausch and Lomb (Manufacturing)

  Jun 2008 - Jun 2015

  Technical Services Team Leader (Senior Process Engineer)

  Design, establish and lead the QA Chemistry, Microbiology, Monomer Mixing, and Solutions Preparation laboratories whose purpose is to provide analytical services to internal customers with respect to raw materials, environmental monitoring, and plant purified water. Develop, establish and maintain laboratory compliance with respect to FDA and ISO regulations for medical devices while utilizing Six Sigma principles to increase the speed of testing execution. Special Projects Streamline the chemistry and microbiology testing to increase the efficiency of the manufacturing operations supply chainDesign and implement the chemistry laboratory to reduce the cost of quality in Rochester manufacturingBuild and maintain a collaborative atmosphere between Rochester manufacturing and R&DBring the Six Sigma approach to the laboratories Head of Analytical Services and Reference Standards Show less

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  Catalent Pharma Solutions

  Jul 2015 - Oct 2020

  Six Sigma Black Belt: Continually improving processes from a department level ensuring engagement and adherence.

  • QA Compliance Training Manager

    Jun 2019 - Oct 2020

  • Continuous Improvement, Process Leader

    Mar 2016 - Oct 2020

  • Data Auditor

    Jul 2015 - Oct 2020
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  ISPE

  Oct 2020 - now

  Sr. Director, Professional Development