James S. Bonner: Education Washington State University

James S.
Bonner
EDUCATION
Washington State University
Bachelor of Science, Biology
Bachelor of Science, Biotechnology
RELEVANT EXPERIENCE
Abzena (San Diego)

Downstream Manufacturing Associate II Nov 2020- Feb 2021
Manufacturing Associate Downstream Purification. AKTA skids, Lysis, Harvest. Pro A Cycles, UFDF, antibody
purification, protein purification, Column HPLC, DoE, some Method Development with Unicorn Software. De-
pyrogenation of columns, low flow kits, Familiar with PPD's, Anion Exchange, Cation Exchange, Hydrophobic,
Size Exclusion HPLC, viral filtration. Able to follow AKTA Unicorn Software. Flow cytometry, Authoring and
Revising SOP's. Batch Records, Autoclaving tubing assemblies, assembling Tubing assemblies from product
specs. Small and large batch Buffer Preparation, familiar with Zen QMS, gowning, Cleanroom Production
experience. Inventory Control within an ERP. Room, Area, and Line Clearances. Material Transfers, Filter
Integrity Tests. Familiar with Sartorius equipment.
Lot Traces for all released inventory. Pallet Tanks and mag mixers. Material Transfer through passthrough's.
Coordinating with QA and QC, manufactured products. CIP and TOC, endotoxin sampling. Assisted with process
development various experimental campaigns. Compliance with ISO 13485 regulations. Familiar with all
temperature sensitive pH and Conductivity meters. Floor Scales, BSL-2 Hood sampling methods. Sartorius
Filtration aseptic assembly in hoods, weekly safety meetings, Watson-Marlow pumps, keen understanding of all
bio-processing procedures Upstream and Downstream.
Thermofisher (Carlsbad,CA)
Contract Project Coordinator II Nov 2019- Oct 30 2020
Worked for the CSO group. Custom, Specialization, and OEM for Catalog Products with major biotech
companies internationally. Ensure that all projects are delivered on-time, within scope and within budget and
coordinate internal resources and third parties/vendors for the flawless execution of projects. Ensure resource
availability and allocation.
Coordinated internal resources and third parties/vendors for the flawless execution of projects and new SKU
creation for Oligonucleotide Synthesis, Peptides, HF cleavage.
Developed a detailed project plan to track progress, Solid knowledge of HIPPA within the medical field,
pharmaceutical, & Biotech industry.Ability to critically evaluate the quality of scientific assay data and results.
Excellent written and oral communication skills and attentiveness to detail while serving Customer needs.
Superb knowledge and skill in Microsoft Office applications (Word, Teams, Power Point, MS Project,and Excel)
as well as Oracle Enterprise Systems, Trackwise for PR's, Agile, CRM FreshSales, and Documentum. Ability to
interact effectively with nationally recognized experts in a field while coordinating new SKU projects with major
International Customers.
Knowledge of the scientific methods applied to clinical research and the current legislative/regulatory controls.
Demonstrated ability to trouble-shoot complex problems and to work effectively in a multi-disciplinary team.
Genopis Inc. (San Diego, CA)

Contract Manufacturing Assistant III
FDA Clinical Trials Phase III March 2019-Sep 2019
ISO Cleanroom 5. FDA Clinical Trials Phase III for Diabetic neuropathy and ALS disease. Plasmid Fermentation
600L, 400L, 250L Media Tanks, Vessels, clean in out of place, CIP/COP of all production parts, antibody
purification, new equipment validation work, Lysis, PSX Column Chromatography, some Unicorn software DoE,
UV-VIS, AKTA, HPLC, Manufacturing buffers, media, and reagents, cross-trained in MM, QC duties, inventory,
Upstream and Downstream. Unicorn Software for GE AKTA, knowledgeable about DoE/Monte Carlo. Braun
Fermentation equipment and interface. Ultra Filtration/Defiltrations UF/DF, QC records and, SOP's, and FRM's.
Worked in conjunction with QA Environmental monitoring, dispensing chemicals, following SOP's in an
ISO/FDA cleanroom 5, for injectable drugs. Writing SOP's, batch record processing. Assisted with data collection
for Validation of new equipment - IQ, OQ, and PQ's.
Biofluidica (San Diego, CA)

Manufacturing Assistant Contractor Dec/2018-Feb 2019
Microfluidic chip cleaning and thermal bonding, application of surface
molecules to microfluidic chips, quality control testing, optimization of assay performance, report
writing, preparation of SOPs. Antibody conjugation, stock solution preparation, oncology research, FISH.
National University/ UC Davis

Courses Nov/2017-Nov/2018
Organic Chemistry, Hematology, Pharmacology, Biochemistry
Roka BioScience (San Diego)

Production Chemist GMP Manufacturing Microbiology Lab
Aug/2012-
Nov/2017
 PCR, HPLC, GCMS, Purification, ELISA
 Production Chemistry Reagents, DNA/RNA extraction.
 In house Oligonucleotide Manufacturing, AE Probe Labeling, Peptides, HF cleavage.
 Aseptic Techniques, Gowning, PPE
 Microbiology BSL2 Laboratory Experience, SDS Page, Gel electrophoresis.
 Plating, Latex Agglutination PCR, Electrophoresis, working under the hood
 Listeria, Salmonella, E. coli, Mycobacterium Assay Development, Flow Cytometry
 GMP, ISO, GLP knowledgeable
 Follow SOP’s. UV spec, Lyophilization, Autoclave, Restriction digests
 Controls, Transfer Media, Bulk Solutions, Cleanroom Experience,
 Manufacture of Calibrators, Equipment operation, packaging, assembly
 Collaborated with Method Development Team for Mfg. schedule products
 Maintained updated inventories, documentation, and proper environmental storage of reference drug
compounds
 QC duties for Environmental monitoring, audits, document revisions
 Prepared stock solutions, working solutions, and QC samples per guidelines presented in bioanalytical
protocols (BPs)
 Established compound stability of stock solutions, working solutions, and QC samples
 Worked with QAU and Safety Officers to maintain a safe, compliant laboratory environment
 Reviewed standards paperwork, data tables, validated bioanalytical reports, and written laboratory SOPs
 Maintained appropriate documentation of all work as per Good Laboratory Practices (GLPs) and
regulatory guidelines
 Presented reports at company meetings.
Phamatech CLIA lab (San Diego)

Quality Control Analyst May/2011-Aug/2012
 Released produced Conjugate Pads in a busy CLIA lab for DOA assays for Methamphetamine,
Amphetamine, Benzodiazepines, Methadone metabolites.
 Worked closely with MFG for releasing Lots for Manufacture
 Produced controls for all other DOA assays at designated concentrations
 Confirmed controls via GCMS, released to Mfg.
 Established compound stability of stock solutions, working solutions, and QC samples
 Worked with QAU and Safety Officers to maintain a safe, compliant laboratory environment
 Reviewed standards paperwork, data tables, validated bioanalytical reports, and written laboratory SOPs
 Maintained appropriate documentation of all work as per Good Laboratory Practices (GLPs) and
regulatory guidelines
Eco Analysts, Moscow, ID July/2008-Oct/2009

Research Assistant
 Sorted soil and water samples for taxonomic classification
 Microscopy skills and prepared reports for Taxonomic Scientists
LABORATORY EXPERIENCE
Research Assistant
USDA Plant Transformation lab, WSU Pullman, WA
USDA Wheat Genetics lab, WSU Pullman, WA May/2007- July/2008
 In charge of Fusarium (stripe rust) inoculation project with Wheat

 Cleaned glassware and maintained general laboratory supplies and stock solutions
 Experienced with DNA extraction from wheat, peas, agrobacterium, PCR amplification, gel
electrophoresis, and bacterial plating, GFP labeling, SDS page, ELISA
 Sample prep/PCR wheat cultivars for future plant breeding and cold tolerance, drought resistance,
increased nutrient content, pathogen resistance
LEADERSHIP EXPERIENCE
English Teacher
Topia Canadian Language School Ansan-si, Seoul, South Korea Oct/2009-May/2011
 Lesson plans, grading, consult with textbook writing, school promotion events, cultural events
 Participated in weekly Korean Language Skill Classes
LABORATORY SKILLS
Apparatus  Preparation of working solutions for LCMS

 Balances (Analytical and microbalance)  Exposure to liquid-liquid extraction
 Pipettes (air/positive displacement, volumetric) Extraction Skills
 Filling Equipment, Torque Wrenches  Experience with light sensitive compounds, AE
 Volumetric glassware  Experience with low-stability compounds
 Autoclave  Experienced in handling various biological
Industry Skills matrices
 Current Good Laboratory Practices (cGLP)
 ISO:13485 & IS0: 9001 Additional Skills
 Current Good Manufacturing Practices (cGMP)  JD Edwards Inventory Management System
 Current Good Documentation Practices (cGDP)  FreshSales CRM, Agile, Scrum, 6S Lean Sigma
 Exposure to LEAN Manufacturing and Six
Sigma  Advanced understanding of Microsoft Office
 Kaizen/GEMBA Suite, Microsoft Teams,
 Experienced in the implementation of 6S  Webex
Optimization  Minitab/StatCrunch, TrackWise, GEMBA,
Analytical Skills DCW, OSCAR, Affeymetrix File Maker
 Precision pipetting of microliter samples  Online research tools/databases (SciFinder,
 Serial dilutions accurate to within 2% Pubmed)
 Precision weighing of 0.5 microgram powders
 Shimadzu HPLC, LabSolutions Software,
Unicorn Software for GE AKTA
 Nano-Drop, Concentration
 Korean Language, elementary level

 Project Management Professional Course, PMI
Study Group
 Human Anatomy and Physiology Courses I and
II, Medical Surgical Nursing I,II,
Pharmacology, Hematology, Biochemistry,
Analytical Chemistry, Statistics for Life
Scientists, within the last 2 years.
PROFESSIONAL REFERENCES:
Russ Genaro, HR Abzena (619)-826-6483
Kayla Diaz, Supervisor of Manufacturing, Abzena

(760)-430-9375
Laura Nieman, Sr. Human Resources Manager,
Genopis, 858-622-1681 Ext. 103
Michael Gore, Previous Manager, Roka Bioscience:
(858) 388-9377
Jacqueline Franko: Contract Manager, ThermoFisher
(619)-272-5555 Ext. 66011

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James S.

Abzena (San Diego)

Genopis Inc. (San Diego, CA)

Biofluidica (San Diego, CA)

National University/ UC Davis

Roka BioScience (San Diego)

Phamatech CLIA lab (San Diego)

Eco Analysts, Moscow, ID July/2008-Oct/2009

 In charge of Fusarium (stripe rust) inoculation project with Wheat

Apparatus  Preparation of working solutions for LCMS

 Korean Language, elementary level

Kayla Diaz, Supervisor of Manufacturing, Abzena

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