Clinical chemistry coordinator, technical consultant, statistician

ANDREW J. NELSON

Plainfield, IL

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

KEY ATTRIBUTES

• Medical technologist with experience in high complexity testing, lab operations, Quality Control, and Lean/Six Sigma/continuous improvement

• Expert level instrument troubleshooting, method validation on Beckman Coulter AU, DXI, DXH

• 8 years’ project management experience, 5 years supervisory/managerial.

• Supply chain management- I can solve complex problems with practical and implementable solutions

• Advanced Excel, Matlab, and R skills used to analyze research data

• Analytical and qualitative support for medical device research, development, and production

• Experience in clinical, research, and production lab modalities in compliance with FDA, Joint Commission, and CAP compliance and regulations, as well as GMP/GLP standards

• Experienced in all aspects of fermentation for medical and food production EDUCATION

University of Illinois- Urbana-Champaign, IL August 2014 Bachelor of Science – Integrative Biology

Concentrations: Plant Physiology, Crop Science

Merit Program for Emerging Scholars in Math, Chemistry, Biology: Award for Academic Achievement PROFESSIONAL EXPERIENCE

SNT Biotech Labs - Plainfield, IL May 2025 - Present Technical Consultant

This is a startup biotechnology company that specializes in providing and processing at-home test kits. I am consulting on their operations in order to validate multiple Lab-developed tests on a very tight budget and deadline. This has required root cause analysis of why their validations have failed, a multimodal plan to fix it, followed by the method validations, including regression analyses to ensure the instrument reliably analyzes the desired assays with acceptable precision and accuracy. I have delivered validations on the required tests 3 weeks ahead of schedule.

St. Joseph Medical Center – Joliet, IL

Clinical Laboratory Scientist II June 2022 - Present

As a generalist, I work all benches, promoting accurate reporting of patient testing

Working closely with the chemistry coordinator and IT, I validated two new Beckman DXC700 analyzers with Remisol and Meditech, a task that would have taken a month or more, we completed in one week.

I set up our lab’s new Unity Real Time, mapping tests and ensuring accuracy in test stats and rules.

I’m responsible for all lab employees’ competencies, ensuring that they are fully trained and maintain their ability to perform lab testing competently, and that they meet our lab’s performance standards.

Responsible for Metrics/KPIs, lab-wide CAP proficiency testing, maintaining CLIA compliance and CAP accreditation, document control of lab records, writing Standard Operating Procedures, and employee competencies

Key operator on chemistry analyzers, responsible for maintaining equipment and for training coworkers on operation; in addition, I perform periodic validations, linearity, method, compliance testing, and document control of all equipment maintenance and deviation records.

Responsible for determining and fixing root causes of any unacceptable fluctuations in analyzer performance and Quality Control and for training coworkers on Quality Control protocols Self – Plainfield, IL January 2016 – Present

Analyst

Consult on clients’ research projects, industry white papers and individual publications

Consult on design, methods, and editing articles for publication

The majority of my responsibilities involve performing statistical analyses for clients. Nature’s Fynd – Chicago, IL December 2018 – May 2021 Fermentation Engineer

Installed, operated and maintained fermenters through expanded production

Maintained batch records and document controls

Aligned production and quality departments by implementing a standardized reporting system Abbott Laboratories – Abbott Park, IL July 2017 – July 2018 Lead Fermentation Engineer

Supervised 20 employees in the Rare Reagent Division

Directed small and large scale rare reagent fermentation in FDA-monitored BSL-II and III facilities.

Accelerated SOD (superoxide dismutase) yields by 8% over six months by restructuring process steps

Participated in CAPA investigations and root cause analyses of operator and equipment error North Suburban YMCA – Northbrook, IL September 2016 – July 2017 Associate

Implemented new emergency response protocols, alongside fire and police districts

Overhauled building security system and maintained building safely Viscofan USA, Inc. – Danville, IL November 2014 – January 2016 Quality Control Specialist

Managed a team of 8 quality engineers, handling scheduling, training, and personnel records

Analyzed final products with bench top chemistry to ensure products were within acceptable margins

Authored weekly reports detailing test results, in addition to any deviations from GMP practices

Reported compliance with FDA regulations, as well as internal quality and safety standards Institute for Genomic Biology – Urbana, IL August 2013 – November 2014 Staff Researcher

Executed project and workflow timetables to meet seasonal, regulatory, and financial restrictions

Recruited and trained research assistants for lab and field work

Responsible for both field and lab work to isolate, identify, and quantify nutrient fluxes in crop systems

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