Svoboda Ben - Resume 16-0411
- 1. Benjamin R. Svoboda 21055th Ave - Apt 705, Seattle,WA98121 (303) 746-9901 svo913@gmail.com OBJECTIVE My objective is to obtain a laboratory position supporting the testing, development, validation, transfer, and automation of analytical methods in support of therapeutic drug development. QUALIFICATION SUMMARY I have over 10 years of experience in pharmaceutical Quality Control (QC) and Process and Product Engineering (P&PE) laboratories assisting in the development, validation, transfer, and automation of Bioassay and ELISA methods used to analyze In-Process, CIP, and Drug SubstanceProduct samples under cGMP regulations. During this time, I have achieved a technical knowledge of the performance and maintenance of cell- based and immunochemistry assays, and an understanding of the drug development and commercialization processes. I am comfortable with cell culture techniques, and the use of Ready-to- Plate (RTP) cells in performing bioassays. Additionally, I have actively taken a leadership role in training analysts across multiple Amgen sites, including Amgen Colorado (ACO), Amgen Rhode Island (ARI), Amgen Puerto Rico (AML), and Amgen Dun Laoghaire (ADL). Over the past 8 years, I have been automating bioassay and immunoassay methods using the Tecan Freedom EVO automated liquid handling platform. In addition to implementing bioassay and immunoassay automation at the Amgen Colorado (ACO) site, I have developed innovate techniques for transferring scripts between Tecan robots within and across global laboratories. I remain critical of the tasks I perform and continually seek to improve the quality of the science and processes by which they are executed. I enjoy expanding my scientific knowledge and look forward to continuing this pursuit in a development environment. PROFESSIONALSKILLS Bioassay (Cell-Based Assays) Development, validation, transfer, and automation of proliferation, reporter gene, and AlphaLISA methods for relative potency determination of active pharmaceutical ingredients (Amgen, Inc.) Cell culture and use of Ready-to-Plate (RTP) cells in performing bioassays (Amgen, Inc.) Assist in the maintenance and trending of assays and reagents Leadership role in training analysts on bioassays at multiple Amgen sites (ACO, ARI, AML, ADL) HTRF (Homogeneous Time Resolved Fluorescence) Performance of HTRF method for relative potency determination of active pharmaceutical ingredients (Amgen, Inc.).
- 2. BioELISA Excellence in Operations Award (2012) for aid in developing, validating, and automating a BioELISA for the detection of anti-IL-17 receptor monoclonal antibody, AMG 827 (Amgen, Inc.). ELISA (Enzyme Linked Immunosorbent Assays) Development, validation, transfer, and automation of ELISA methods for detection of active pharmaceutical ingredients, impurities, and contaminants (Amgen, Inc., Lancaster Laboratories). Development and performance of ELISA methods for meat speciation and allergen detection in food products (ELISA Technologies). Performance of ELISA method for detection of blood components during FDA 510(k) validation of a novel medical device and protein purification kit for wound healing (COBE Cardiovascular). LPLC (Low Pressure Liquid Chromatography) Use of gel filtration (G200) and ion-exchange (DEAE, CM23) columns for purification of IgG for use in ELISA methods (ELISA Technologies). Laboratory Automation (Tecan Freedom EVO) Script development, qualification, and performance of Bioassay and Immunoassay methods on the Tecan Freedom EVO automated liquid handling platform using Freedom EVOware software (Amgen, Inc.). Leadership role in training analysts on Tecans at multiple Amgen sites (ACO, ARI, ADL) Author of global SOP for qualification of Tecan automation in cGMP labs (Amgen, Inc.) Innovative techniques for transferring scripts between Tecan robots within and across global laboratories. (Amgen, Inc.) cGMP (Current Good Manufacturing Practice) Development, validation, transfer, and automation of analytical methods in a cGMP environment for a major pharmaceutical company (Amgen, Inc., Lancaster Laboratories). Laboratory Efficiency (LEAN Initiatives) Creation and implementation of process boards in lab using six sigma methodology (Amgen, Inc). Creation and implementation of kanban inventory system to organize requests and ordering of lab reagents and materials (Amgen, Inc.). Creation of controlled worksheets for calculation of assay dilutions and assay performance for use with Tecan Freedom EVO platform (Amgen, Inc.). EMPLOYMENTHISTORY The DiLisi Group, Inc. Feb 2016 – Current Quality Consultant Consulting support for Amgen, Inc. (Thousand Oaks, CA). Manage projects for creation of a global automation program across multiple network sites. Automation of bioassay analytical methods using the Tecan Freedom EVO platform. Training of Subject Matter Experts (SME) to support global automation program.
- 3. Amgen, Inc. – LongmontBoulder, CO Oct 2005 – May 2015 Specialist, Quality Control, QC (Jul 2012 – May 2015) Performance, development, validation, and transfer of immunoassay and bioassay analytical methods for Quality Control (QC) under current Good Manufacturing Practices (cGMP). Automation of bioassay and immunoassay methods using the Tecan Freedom EVO platform. Associate Scientist, Process and Product Engineering, P&PE (Jan 2010 – Jul 2012) Performance and transfer of immunoassay and bioassay analytical methods in a development laboratory responsible for method remediation. Automation of immunoassay and bioassay analytical methods using the Tecan Freedom EVO platform. Implementation of monthly maintenance plan and guidance document for Tecan systems. Senior Associate, Quality Control, QC (Oct 2005 – Dec 2009) Performance, development, validation, and transfer of immunoassay and bioassay analytical methods for Quality Control (QC) under current Good Manufacturing Practices (cGMP). Automation of immunoassay analytical methods using the Tecan Freedom EVO platform. Creation and implementation of kanban inventory system to organize requests and ordering of lab reagents and materials. Lancaster Laboratories – Longmont, CO Jun 2004 – Oct 2005 Lab Analyst (contracted to Amgen, Inc. in Longmont, CO) Performance, validation, and transfer of analytical methods for Quality Control (QC) using cGMP. COBE Cardiovascular – Arvada, CO Nov 2003 – Jun 2004 Laboratory Technician (contracted by Kelly Scientific Services) Aided in testing and FDA 510(k) validation of a novel medical device and protein purification kit for use in wound healing. ELISA Technologies – Gainesville, FL Jan 2001 – Jul 2003 Laboratory Analyst, Production Supervisor Performance, development and customer support for ELISA kits intended for meat speciation and allergen detection in food products. Production supervision of kits and components. EDUCATION B.S., Microbiology and Cell Science – May 2003 University of Florida – Gainesville, FL PROFESSIONALREFERENCES Available upon request.