Gary Silver

Gary Silver Email and Phone Number

Analytical Development and Quality Control Professional @ Veolia Water Technologies & Solutions
Gary Silver's Location
Lafayette, Colorado, United States, United States
Gary Silver's Contact Details

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About Gary Silver

Biochemist specializing in Product Development, Quality Control and Regulatory Compliance in a global marketplace. Recognized for technical acumen, leadership, accountability, communication, and collaboration. Authored papers and awarded numerous patents. Expertise includes: Analytical method development, LAL, bioburden, protein purification, HPLC, electrophoresis, molecular biology, cGMP, quality control, product and device stability, validation, regulatory, LIMS, technical writing, environmental health and safety, and program management.

Gary Silver's Current Company Details
Veolia Water Technologies & Solutions

Veolia Water Technologies & Solutions

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Analytical Development and Quality Control Professional
Gary Silver Work Experience Details
  • Veolia Water Technologies & Solutions
    Advanced Lead Engineer
    Veolia Water Technologies & Solutions Apr 2017 - Present
    Boulder, Co
    Lead biochemical engineer focusing on the development and commercialization of leading edge rapid bioburden and endotoxin detection systems, including the Sievers Soleil Rapid Bioburden Analyzer and the Eclipse microfluidic Bacterial Endotoxin Test Platform. Responsibilities include product formulation development, analytical testing, troubleshooting, stability program management, data analysis, and product validation, as well as working directly with CMO to create efficient, robust, and consistent manufacturing processes following cGMP principles.
  • Flatiron Scientific Llc
    Principal Consultant
    Flatiron Scientific Llc Mar 2017 - Present
    Boulder, Colorado
    Specializing in Quality Control, cGMP compliance, Product Stability, and Analytical Method Development
  • Ophthotech
    Senior Scientist, Quality Control And Analytical Development
    Ophthotech May 2016 - Mar 2017
    Boulder, Colorado
    Senior scientist overseeing Quality Control and Analytical Development activities at contract research organizations (CROs). Responsibilities include oversight of method optimization, transfers, and validation, testing coordination, design and monitoring of stability studies, batch record review, CMC section authoring and review, and cGMP compliance auditing.
  • Pfizer
    Technical Manager, Global Biologics R&D
    Pfizer Oct 2015 - Apr 2016
    Lake Forest, Illinois
    Technical Manager (contractor), overseeing testing at CROs and Pfizer sites for projects in the pre-commercial phase of development. This includes oversight of stability studies, assay trending, and writing exception reports and CAPAs.  Liaison between research scientists and CROs and responsible for preparation of scientific reports, protocols, procedures and manuscripts.
  • Amgen
    Product Quality Specialist
    Amgen Sep 2005 - May 2015
    Longmont, Co
    Product Quality Specialist, responsible for the stability programs for several commercial and clinical products, supporting product storage and expiry, regulatory filings, and investigations. As a QC Specialist, my primary focus was on method transfers, validations, and remediation in a cGMP environment. In addition, I have had several roles in Health and Safety, including ergonomic evaluations, managing the building evacuation program, leading the employee safety team, and hazardous material response.
  • Ceptyr, Inc.
    Scientist
    Ceptyr, Inc. Dec 2000 - Nov 2004
    Bothell, Wa
    CEPTYR's research focused on Protein Tyrosine Phosphatases, or PTPs. Many PTPs control metabolism and celluar growth, and thus are important in diseases such as cancer and diabetes. I primarily cultured and purified recombinant PTPs. I also developed high-throughput screening assays to find drugs that would target the PTPs and potentially treat certain diseases. In addition, I was the leader of the company Safety Committee and HazMat Emergency Response Team.
  • Mds Pharma Services
    Scientist (Contract)
    Mds Pharma Services Jul 2000 - Dec 2000
    Bothell, Wa
    Purified a variety of proteins as a contract researcher. Brought new technology and approaches to sample purification and analysis.
  • Heska Corporation
    Senior Scientist
    Heska Corporation Jan 1995 - Jul 2000
    Fort Collins, Co
    Lead biochemist in the Pharmaceutical Discovery Group. My main research was focused on preventing fleas and ticks from biting dogs and cats through the development of novel vaccines and drugs. In addition, I was focused on developing a new anti-inflammatory/pain reliever for dogs.

Gary Silver Skills

Gmp Biotechnology Validation Biopharmaceuticals Lims Protein Chemistry Fda Assay Development Laboratory Pharmaceutical Industry Technology Transfer Sop Purification Quality Control Life Sciences Capa Hplc Biochemistry Chromatography Protein Purification Aseptic Processing U.s. Food And Drug Administration Vaccines High Throughput Screening Cancer Lifesciences Glp Pharmaceutics Elisa Standard Operating Procedure 21 Cfr Part 11 Drug Discovery Regulatory Submissions Uv/vis Mass Spectrometry Trackwise Gas Chromatography Drug Development Sds Page R Gel Electrophoresis Analytical Method Validation Regulatory Requirements Western Blotting Fda Gmp Molecular Biology Analytical Chemistry Research And Development Change Control

Gary Silver Education Details

Frequently Asked Questions about Gary Silver

What company does Gary Silver work for?

Gary Silver works for Veolia Water Technologies & Solutions

What is Gary Silver's role at the current company?

Gary Silver's current role is Analytical Development and Quality Control Professional.

What is Gary Silver's email address?

Gary Silver's email address is ga****@****uez.com

What is Gary Silver's direct phone number?

Gary Silver's direct phone number is 130333*****

What schools did Gary Silver attend?

Gary Silver attended University Of Colorado Boulder, University Of California, Santa Cruz.

What skills is Gary Silver known for?

Gary Silver has skills like Gmp, Biotechnology, Validation, Biopharmaceuticals, Lims, Protein Chemistry, Fda, Assay Development, Laboratory, Pharmaceutical Industry, Technology Transfer, Sop.

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