8949759_187006_Eva Reinante Resume Biotechnology Quality

Eva K. Reinante, MBA
10540 Dresden St., Firestone, CO 80504
(303) 995-3047, [email protected]
Extensive experience in the biotechnology industry. Recognized as a top performer for organizing, planning and
executing complex projects within stringent time and budget constraints and under minimal supervision.
Business professional with focus on process improvements and finding logical solutions to manage business
processes. Skilled in communication, collaboration, training/mentoring, lean operational excellence, and
customer service. Expertise includes:
Quality Assurance
Quality Control
Audit and Inspection Support
Regulatory Compliance
Process Improvement
Project Management
Technical Writing
Data Management and Analysis
Database Management
CAPA and Change Control
Data Review and Approval
Global and Cross-Functional Team
AMGEN, INC., Longmont, CO
Product Quality Senior Stability Associate (2012-2015)
Served as a Project Manager for cross-functional stability projects for over 50 commercial, biosimilar, and
clinical stability programs while following regulatory guidelines and timelines. Led and supported process
improvement, CAPA and change control projects. Provided stability study management, stability data
management, data analysis and trending, stability investigation, and audit support. Reviewed, approved, and
data verified regulatory submissions and technical documents including comparability protocols, annual
product review reports, specification technical reports, master data spreadsheets, investigation reports, and
stability documents. Provided training for multiple team members and new hires. Laboratory Information
Management System (LIMS) templator and troubleshooter and iStudy Reporter expert.
Regulatory - Accountable for the stability annual lots program at Amgen and contract sites globally.
Procured over 60 lots from 13 Amgen and contract manufacturing sites for 12 commercial products to
fulfill Amgen’s stability annual lot program for 2015. Coordinated the annual lot stability testing across
eight Amgen sites and five time zones to satisfy FDA/ICH/ISO regulatory requirements.
Technical Writing - Owned, authored and revised SOPs, technical reports, protocols and regulatory
documents to ensure compliance with regulatory guidelines.
Change Control - Managed the site transfer of 200 commercial stability studies for five Amgen products
to two sites and was responsible for timelines and transfer reports generation.
Study Management - Created, managed and finalized over 400 stability studies for commercial and
clinical products to ensure timely achievement of regulatory and corporate goals.
Data Management - Migrated over 8000 stability tests for 120 studies for four Amgen commercial
products. Managed four resources to accomplish project goals and timelines.
Process Improvement - Reduced temperature excursion assessment turnaround time from five days to
one day by implementing a new product quality assessment program.
Resource Planning and Scheduling – Coordinated short term and long term scheduling of stability
technical support activities with an average of 150 tasks per month for 37 molecules utilizing seven
Eva Reinante, MBA (303-995-3047)
Database Management - Designed, implemented and maintained SharePoint sites for a 30-person
multinational team which increased the communication efficiency, enhanced collaboration, balanced
the workload among team members and established headcount requirements.
Product Quality - Provided temperature excursion assessment support for commercially distributed
Amgen products, out of specification result investigations, and change control assessments.
QA - Reviewed/approved over 200 documents and regulatory filings in excess of half million data
Quality Control Technical Product Support Senior Associate (2010-2012)
Oversaw critical reagent management to support international expansion strategy. Managed inventory, created
and maintained reagent database, procured reagents, monitored and analyzed reagent forecasting.
Database Management - Reorganized the global critical reagent tracking system across Amgen that
improved document retrieval and expiration tracking.
Technical Writing - Contributed to the writing of Global Operating Procedures that governed critical
reagent use. Authored and owned certificates of analysis documents, reports and release memos to
support method transfer for commercial products between sites and internationally.
Process Improvement - Designed and implemented a new process for shipping QC materials for
international jurisdictional regulatory requirements for registration and import testing. Between 2011
and 2014, the site processed 1,400 shipments across 53 countries for over 30 Amgen products.
Quality Control Bioanalytical Sciences Senior Associate (2006-2010)
Executed bioassays, including cell proliferation, receptor-ligand binding and reporter gene to determine relative
potency. Performed immunoassays for stability and lot release testing of commercial products. Provided method
development, method transfers, method validation, laboratory investigation and audit support. Analyzed and
interpreted results. Maintained cell cultures of adherent and suspension cell lines to support biological activity
using aseptic techniques. Quality approver of stability and lot release results, cell and solution preps. Trained
analysts to support testing and quality review. Equipment used: TECAN, Vi-CELL, Envision, PowerWave,
Sample Forecast and Coordination – Translated stability and manufacturing schedules into a sample
load forecast for the labs. Coordinated sample testing for a team of 10 analysts for over 450 samples per
month for six commercial products ensuring quality, efficiency and meeting timelines.
Process Improvement – Implemented review checklists and job aides to standardize work and increase
first pass quality. Reduced result turnaround time from 20 days to three days.
QA - Reviewed/approved over 7,000 assays following SOPs.
Research Associate III
Performed research and development in the Eppendorf 5 Prime Proteomics group. Characterized polymerases
for novel PCR applications. Techniques used: protein expression, protein purification and SDS PAGE for
qualitative determination of protein identity and purity.
Molecular Biology - Optimized gene expression and protein purification conditions of thermophilic
polymerases for taq polymerase replacement in commercial PCR kits.
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Eva Reinante, MBA (303-995-3047)
Research Technician III
Performed research in a biomedical research group. Hands on laboratory experience included bacterial cloning
of human proteins, PCR, DNA gel electrophoresis, SDS-PAGE, digestion, ligation, and transformation of cells,
gene expression and purification using ion exchange, affinity and size exclusion chromatographies. Maintained
cell cultures of adherent and suspension cell lines.
 Molecular Biology - Designed plasmid constructs and optimized gene expression of indoleamine 2,3 –
dioxygenase (IDO) for immunoprotection of insulin producing  cells.
 Training/Mentoring - Served as a molecular biology advisor for the lab, supervised undergraduate
 Lab Supply Management - managed ordering and organizing lab supplies to ensured functionality of
the laboratory.
UNIVERSITY OF COLORADO, Department of Chemistry and Biochemistry, Boulder, CO
UNIVERSITY OF COLORADO, Department of Mechanical Engineering, Boulder, CO
CZECH ACADEMY OF SCIENCES, Laboratory of Thermodynamics, Prague, Czech Republic
UNIVERSITY OF CHEMISTRY AND TECHNOLOGY, Laboratory of Chrystal Chemistry, Prague,
Czech Republic
Professional Research Assistant
Research Associate
Master of Business Administration, MBA
University of Phoenix, Phoenix, AZ
Master of Science in Chemical Engineering, MS
University of Chemistry and Technology, Prague, Czech Republic
Bachelor of Arts in Molecular and Cellular Biology, BA
University of Colorado, Boulder, CO
Top Performer Designation – Annual and Mid-Year Reviews -2006 - 2015
Amgen Acclaim Awards – 14 awards recognizing excellence in the workplace – 2007 - 2015
Colorado BioScience Association
Project Management Institute – Certified Associate in Project Management (CAPM) – In Progress
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Eva Reinante, MBA (303-995-3047)
Numerous classes in the area of project management, collaboration services and data analysis. Highlights
include: Project Management Professional (PMP) Certification Preparation (2015), Advanced Microsoft Project
(2014), Six Sigma Green Belt Specialist (2011), Visio Professional, Level 1 and Level 2 (2015), Advanced Excel
(2014), and SharePoint Services, Level 1 and Level 2 (2010).
TerWee, J., Watrin, S., Tello, R., Chin, C., Womack, C., Rieder, N., Lowell , J., Birks, B., Dahl, K.,
Kovacs, E., Waheed, K., Yett, J., Sonnenberg, M: “Utilization of Frozen Cells for Routine Potency
Testing by Bioassay.” AAPS National Biotechnology Conference, June 21-24, Seattle, Washington,
Kovacs E., Zelinskaia N., Wolfson, A. (2005). High-throughput assays of editing by aminoacyl-tRNA
synthetases. Nucleic Acid Research
Kovacs E., Zelinskaia N., Wolfson, A. (2004). High-throughput assays of editing by aminoacyl-tRNA
synthetases. 9th Annual Meeting of the RNA Society, Madison, Wisconsin, June 1-6, 2004.
Kovacs E., Zelinskaia N., Wolfson, A. (2005). Arginyltransferase activity is limiting in degradation of
N-end rule substrates in HeLa cells. FEBS Letters
Kovacs E. and Linek J. (2001). Excess Molar Volumes of an Alkane + 1-Chloroalkane at T = 298.15 K.
J. Chem. Thermodyn. 33 (1) 33-45.
Kovacs E. and Linek J. Excess Molar Volumes of an Alkane + 1-Chloroalkane. 26th International
Conference of Slovak Society of Chemical Engineering, Jasna, Slovakia, May 24-28, 1999.
Linek J. and Kovacs E. and (1999). Densities and Excess Volumes in Binary Mixtures of Heptane with
1-Chloropropane, 1-Chlorobutane, 1-Chloropentane, or 1-Chlorohexane at 298.15 K . Collect. Czech.
Chem. Commun. 64 (3) 495-501.
Kovanda, F., Kovacsova, E. and Kolousek, D. (1999). Removal of Anions from Solutions by Calcinated
Hydrotalcite and Regeneration of Used Sorbent in Repeat Calcination-Rehydration-Anion Exchange
Processes. Collect. Czech. Chem. Commun. 64 1517-1528.
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