Chris Harkins Email & Phone Number

Costa Mesa, Ca, Us

Irvine, Ca, Us

Software:Propel PLM, JIRA, Aligned Elements, GSS, MS Office Suite, Bartender for LabelsFunctions:-Write SOP for Statistical Techniques Including Using the Non-parametric Binomial Distribution with Confidence and Reliability for Attribute Sampling plans.-Write SOP for Incoming Inspection, incorporating Zero Acceptance Sampling Plans.-Write WIs for Propel PLM and other SOPs as needed.-Review/Approve Change Orders-Dimensional Inspections of Incoming Product-Manage Equipment Calibrations-NPSV-Internal Audits.

Rancho Santa Margarita, California, Us

Private research.System test design. Motor controls. Sensor monitoring.

Sr. Test Engineer/Systems Engineer on $25M OEM, automated Immunoassay analyzer development project with anticipated sales of $15M to $18M per year following development. Analyzer based on paramagnetic beads and avidin-biotin capture with a combination of fluorescent and chemiluminescent detection. The system has six rotational pipetting arms and three rotors for samples, reactions and reagents.• Report directly as Systems Engineer to Verification, Project, Program, and Engineering Managers.• Design and develop test methods, procedures and automated scripts for component and system verifications according to System Requirement Specifications.• Accelerated stability testing on hardware components with various chemical solutions.• Design, develop test procedures and automated scripts for R&D. Write Technical Reports.• Perform System, Firmware Version Verification testing.• Read CAD drawings, wiring diagrams for hardware and electrical troubleshooting.• Troubleshooting, hardware upgrades, V&V testing at client site.• SME in immunoassays and automated assay design for ME, EE and FW groups.• Identified issue in magnetic capture system by observation of patterns in results data. Proved my theory empirically and fixed the issue. Present findings to management and manufacturing group. This led to changes in assembly instructions to catch magnet issues before they entered the field.• Invented custom magnetic field detector for this device, allowing detection of proper magnet orientation without requiring laborious disassembly.•Identified three confounding issues in reaction vessel containment causing assay imprecision. Separated, repaired and tested the independent components. Reassembled, tested and proved my fixes produced a drastic improvement in precision; solutions became an ECR.• Developed custom fluorescence based calibrator chip for a separate project.• Developed test method for detecting residual bleach in fluid lines after disinfection procedures.

Systems Development on a multi-sample hardware platform (nRichDX) for Liquid Biopsies.For our testing, we extracted 170bp cell-free, circulating tumor DNA from large specimen volumes using silica coated paramagnetic particles. The platform can also be used for extracting circulating tumor cells from serum/plasma/urine samples.For feasibility, we tested cf-ct DNA kits from Qiagen, Beckman, Thermo (Applied Biosystems), NVIGEN, BIOO scientific and Zymo using spiked 170bp DNA in a modified plasma matrix. We achieved 80% recovery of spiked DNA.Wrote IQ inspection procedure for injection molded part. Performed inspections with calibrated calipers and high resolution camera.Optimized MCF-7 cell capture on lateral-flow device using paramagnetic particles with avidin-biotin capture.- Achieved lower NSB and greater active binding for tumor cell capture.Cell counting with hemocytometer and fluorescence microscopy.

San Diego, Ca, Us

Consulted, remotely, with Ohio staff to ensure thorough product and technology transfer from Immutopics.

At Immutopics we developed and produced ELISA Companion assays and antibodies for IHC for bone metabolism markers. We collaborated with Universities, Pharma and CROs.My responsibilities were: • Managed scientists, customer service, warehouse logistics and administrative personnel in a private ELISA development and manufacturing company specializing in Companion assays for pharma and CROs.• Project lead for process and technology transfer from Immutopics to Quidel (Athens, Ohio).• Worked closely with Quidel personnel at Immutopics and at Quidel to ensure successful transfer. - Completed lab infrastructure migration 3 weeks ahead of schedule.• Collaborated with Division of Pediatric Nephrology, David Geffen School of Medicine at UCLA.• Companion assay development for Mass General, Eli Lilly, Charles River.• Implemented growth strategy by adding four new ELISA products, two IRMA-ELISA kit conversions and five ELISA kit product improvements.• Responsible for QMS. Implemented document control system using document revision numbers and protected network drives for current and obsolete procedures. Implemented lot record retention system.• Provide technical support for entire product line. Investigate customer complaints.• Responsible for USDA/APHIS audits and certification. Responsible for customer audits.• Implemented weekly planning meeting to address production schedule.• Write manufacturing and QC release testing procedures for incoming raw materials, subcomponents and finished products.• Perform QC testing, data analysis on raw materials, intermediate products and finished goods.• Increased product performance through OEM supply chain optimizations.• Schedule and manage work with OEM suppliers.• Human and mouse FGF-23 and PTH 1-34, 1-84 ELISA development.• Produce and test multiple ELISA and IRMA kit components, including antibody coated beads and streptavidin coated microtiter plates.• Purify, conjugate, analyze antibodies for ELISA, IHC

Us

Systems development: Worked with the engineering group to translate manual and partial-automated assay processes and performance to a completely automated platform which was the Nichols *Advantage*Systems development: Working directly with OEM personnel, first line analysis of OEM hardware to select vendors for Nichols first semi-automated Immunoassay platform. Tecan sample pipetting and Berthold Luminometer eventually chosen for the "Chemi" system. Systems development: Chemiluminescence Immunoassays on HPLC. Built two HPLC systems each comprising 3 pumps, 2 multi-position, pneumatic valves, Autosampler and built custom flowcells which allowed me to combine the signal generating reagents directly in front of the PMT in order to capture 100% of signal.Method Development: Working closely with hardware OEM personnel, developed Nichols "Aspirwash" automated wash protocols for Chemiluminescent Immunoassays. Also developed custom wash protocols for customers using coated tubes and various bead sizes.Reagent/Assay development: Developed a Companion assay for Novartis (Basel, CH) to use on the Nichols Advantage platform. Implement/ train in Basel. Resulted in over $1M in sales revenue put directly back into R&D.Analytical Chemistry: MALDI-TOF MS, HPLC, Low Pressure LC, Micro-LC.Antibody conjugations for R&D use: Biotin, Acridinium. Performed HABA assays and MS on conjugates for estimating incorporation of label on antibodies.Paramagnetic particle coating with streptavidin or analyte specific antibodies.Developed the particle blocking mechanism for NID's 25-OH-D Advantage assay.Developed, incorporated procedure for using ultrasound in bulk manufacturing of coated paramagnetic particles for the Advantage assay system.Wrote procedures for the Transition group. In-house Six Sigma training.Translated procedures and timelines of the Transition group into MS Project for the larger scale product development life cycle.

Bachelor’S Degree, Biology/Biological Sciences, General

Pre-Physical Therapy Studies