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.