Quality Control Data

HERMELINDA M. EVANS

***************@*****.***

QUALIFICATIONS

Dynamic, Research Associate with diverse, progressive experience in Biotechnology. Departmental specialties include Bioanalytical, Preclinical, Quality Control, Hematology, Microbiology and Process Development.

PROFESSIONAL EXPERIENCE

BIOMARIN, Novato, California 07/2011-Present

Research Associate, BioAnalytical R&D

• Provide support by testing preclinical and clinical samples for detection of drug, antibodies to protein therapeutics, and biomarkers in biological matrices from non-human and human subjects through multiple stages of development at BioMarin programs.

• Perform ELISA, RIA and ECLA assays to test preclinical samples.

• Perform data analysis.

• Present results and experimental information to supervisor and in departmental meetings.

• Maintain excellent documentation of all work including laboratory notebooks, test methods and other appropriate documentation

DYNAVAX, Berkeley, California 2007 – 2010

Research Associate, Preclinical Research Department

• Maintains comprehensive responsibility for preclinical study coordination, facilitating fulfillment of National Institute of Health (NIH) contract on quarterly basis while executing key testing activities as tissue processing, ELISA, TNA, ICS, Western Blots and ELISPOTS.

• Contribute with verification and validation activities; continually develops new and enhances existing laboratory assays, providing effective training to staff from multiple departments on new or modified assays to assure company-wide consistency.

• Develops and characterizes immunological and cell base assays in support of Dynavax vaccines and therapeutic programs, define and execute experiments to support product research.

• Coordinate in vivo studies including: animal acquisition, protocol writing, immunization preparation and test samples for antibody and cytokine production. Monitor cell lines for preclinical studies.

• Prepare summaries of experimental results by analyzing data using statistical software programs and present data on departmental meetings.

• Perform assays on stability, clinical and preclinical samples. Perform assay validation and sample purification on selected samples.

• Write or update standard operating procedures (SOPs) on new assays and new laboratory protocols. Collaborate with other research associates and senior scientist in various activities to fulfill departmental goals.

• Proficient with Softmax software, Excel and Prism.

• Perform monthly maintenance of GLP plate washer and microplate reader.

CERUS CORPORATION, Concord, California 2000 – 2007

Research Associate, Quality Control/Hematology/Process Development/Microbiology

• Support QC and Microbiology department performing stability studies on various vaccine products, executing real-time and accelerated tests including stress testing, potency, characterization,

degradation, and container and closure inspections. Monitored pH in vials, verified colony forming units in vials and monitor seed-stock stability.

• Executed bacteria growth promotion, early stationary stage and performance of growth curves; analyze for live/dead bacteria via flow methodology. Support sterility test in vaccine vehicle and vials. Maintain data integrity and ensure compliance with SOP Company and FDA specifications.

• Prepare immunizations, collect serum, spleens and tested for hemolysis, antibody and cytokine production with the following methods: ELISA, ICS, ELISPOT, MCP-1, PCR, and Western Blots.

• Transfer studies from research to Quality Control following company and guidelines for proper documentation

• Supported Hematology programs, utilizing Helinix technology including Platelet, Plasma and Red cell projects. Performed in vitro function testing on platelets, and RBC’s measuring HSR, ESC, GMP 140(P-Selectin), counts, morphology, pH, pO2, pCO2 and HCO3, LDH, Glucose, electronic film scoring and aggregates. RBC’s hb, ht, ATP, RBC acridine ab, HgD antigen and morphology.

• Perform IOQ in new equipment; execute verification and validation on new instruments.

• Perform inventory of hematology products in control room under GMP/GLP.

• Use computer system to collect and record data on studies; tabulate data, write summaries and present data. Maintenance in GLP equipment.

BLOOD CENTER OF THE PACIFIC, San Francisco, California 1999 – 2000

Laboratory Technician, Component Laboratory

• Performed a variety of tasks in the laboratory, managed labeling, weighing, and entry of blood products according to categories using LIMS software.

• Prepare blood components as red blood cells, plasma, platelets and other blood components.

• Maintain laboratory equipment; keep clear and accurate laboratory records.

• Follow Federal, State, AABB, BCP policies, procedures and QC standards, GMP and SOP’s.

EDUCATION

GUADALAJARA WOMEN UNIVERSITY.

Bachelor of Science in Medical Laboratory Technology.

LICENSURE AND CONTINUNING EDUCATION

Medical Laboratory Technologist Trainee License, California

IBC USA Conference, 2006-2010

American Association of Blood Banks (AABB) Conferences, 2000, 2001, 2003

American Society of Hematology (ASH), 2002

International Union of Microbiological Societies (IUMS) – Bacteriology and Applied Microbiology, 2002

LABORATORY AND COMPUTERSKILLS

TNA assay, ELISA, PCR, mammalian cell culture,bacteriology, Western Blots, ELISPOT, ICS, LLO hemolysin, MCP-1, protein and antibody purification, platelet and red cells assays, bacterial shaker flask growth, general clinical laboratory analysis, QMS, GLP, GMP, ISO 13485, CFR 21, CLIA adherence, BSL2, BSL3, IQ,OQ,PQ, equipment calibration and maintenance.

Microsoft Office Word, Excel, Prism, PowerPoint, Outlook and Softmax.

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