Founder

Robert E. Young – Owner, Principle Consultant

CGMBS, CLSp(MB), M.S. Bioinformatics

Email: robert@labinsightsllc.com
Robert E. Young

Qualifications

Quality and Compliance Keywords

Compliance Officer, Safety Officer, Privacy Officer, Lab-developed
test validations, CFR 21 part 11 Compliance, Quality Systems
Management, Document Control, FDA clearance, CLIA lab application for
several states, Medicare and Medicaid Application, Inspections and
audits, Quality Control, Quality Assessment, Risk-based decision matrix

Laboratory Keywords

Recombinant DNA techniques, gel and capillary electrophoresis,
microbial and tissue culture, LCMS/MS, HPLC, FPLC, preparation of
radiolabeled compounds, immunofluorescence microscopy, fluorescent
confocal microscopy, genomic and viral sequencing, RT-PCR, PCR, various
real-time PCR methods, urine, genital, strep, other clinical microbe
colony culture and isolation, fungal slide culture preparation,
radioimmunoassays to quantify various steroids. QA/QC/QI data analysis
in a CLIA and FDA regulated Laboratory. NuGen® linear amplification and
Affymetrix® microarray systems.

Application Keywords

Competent to proficient in following programs: MS Word, Works, Power
Point, FrontPage, Access, Excel, Sigma Plot, RasMol, Labsys, PowerTerm,
Seqscape, Sequencher, BioEdit & ClustalW experience as well as
other clustering software and bioinformatics, JMP, Schuylab, StarLIMS,
APVx, Xifin, Orchard, MasterControl, HPQC, RStudio, Jupyter Notebook, Jasper Reports

Programming experience

Python, Visual Basic, C++, C#, Perl, R, StarLiMS Scripting Language,
Javascript, SQL, HTML5, ASP .Net

Education and Certicications

Years Location Description
2007 – 2009 Polytechnic Institute of NYU, Brooklyn, NY Master of Science in Bioinformatics.
Thesis title: A Novel Algorithm For Microarray Splice Junction Probe
Design
2005 – 2006 Quest Diagnostics, Nichols Institute, San Juan Capistrano, CA CA State (CGBMS License #MTP176)
ASCP (MB(ASCP) Limited Licenses in Clinical Molecular Biology
1998 – 2002 Bucknell University, Lewisburg, PA Bachelor of Science in Biochemistry/ Cell Biology,
minor in French

Employment

2012 – Present Lab Insights LLC, Owner

  • Designed and implemented a Data Warehouse, uniting data from 5 independent systems into a common data model
  • Developed bespoke Laboratory Information System for an emerging clinical molecular diagnostic company, complete with REST-APIs, HIPAA compliance, and interfacing with external systems.
  • Developed bespoke Client Relationship Management system for an emerging clinical molecular diagnostic company.
  • Served as Business Analyst and Subject Matter expert in documenting system requirements and writing test cases for a Laboratory Information System for a clinical molecular diagnostics company.
  • Served as Business Analyst and Subject Matter expert in a creating a ISA-88-like Process Taxonomy for a global leader in pharmaceuticals, in collaboration with the Allotrope Foundation. Also assisted in the creation of other taxonomies and ontologies in an effort to standardize the language used to describe pharmaceutical equipment and materials.
  • Served as Business Analyst in a global Data Standardization initiative in order to harmonize data from 4 systems. Helped develop a cross-system ontology based on internationally-recognized thesaurus databases as a foundation for future data consolidation, business intelligence, and migration efforts. Also served as Business Analyst for data migration using the aforementioned Data Standards initiative.
  • Managed LIMS implementation project with 4 staff members, 7 interfaces, 3 outside vendors, and a budget of $200,000+. Created all project documents, as well as software development life-cycle and coding standard procedures. Led configuration, external development, design and implementation.
  • Lead efforts to improve 21 CFR 820 and 11 compliance for validation of globally-deployed computer systems.
  • Executed FDA and GAMP5-compliant validation protocols for globally-deployed ERP system.
  • Designed, implemented and executed FDA and GAMP5-compliant validation for various laboratory equipment software for GMP manufacturing site.
  • Designed, implemented and executed CAP, FDA and GAMP5-compliant validation protocols for Clinical Laboratory LIMS and data analysis modules.
  • Acted as business analyst for several validation projects in order to discern clear, testable user and functional requirements.
  • Developed Quality plan, Quality Control procedures, Document control policies and molecular diagnostic standard operation procedures for several CLIA Laboratories
  • Developed PCR-based diagnostics tests for molecular oncology based on personal expertise and kit package inserts. Developed CLIA and CAP-compliant validation protocols for lab- developed assays.
  • Performed 3rd party Inspections for Lab accreditation readiness. Documented compliance gaps, recommended corrective and preventative actions. Created new documents, updated existing documents, and re-trained staff in the lab’s quality plan, EHS program and validation protocols to ensure accreditation compliance.
  • Authored thought leadership whitepapers for trends in Laboratory-Developed test regulation, HIPAA compliance, validation, and other areas

2013: LabAnswer Informatics Consulting. Informatics
Consultant

  • Lead role in several LIMS implementations.
  • Served as Business analyst, LIMS developer, project manager,
    validation specialist, and strategic assessor.
  • Conducted laboratory business flow analysis and created
    informative Use Cases for the LIMS. Assessed the capabilities of a
    proposed LIMS design the Lab’s current process, and discovered ways to
    maximize LIMS and where we can decrease process inefficiency. Assessed
    Use Cases against the capabilities of StarLIMS. Reviewed and contrasted
    use cases against industry best practices. Assessed use cases against
    regulatory compliance (FDA (Part 11), HIPAA, CLIA, CLSI) guidelines.
    Evaluated the entire LIMS architecture (data flow) and presented a gap
    analysis of current application architecture against the proposed
    future state. Provided a recommendation of long-term roadmap of the
    architecture (for the applications/systems that are involved in the
    laboratory business use cases). Rewrote gene expression profile
    algorithm to improve functionality and performance.
  • Assisted laboratory in creating user requirements based on domain
    knowledge and best practices. Designed, developed and implemented new
    modules and data tables according to user experience and functional
    requirements. Customized existing modules to improve user experience
    and to meet new functional requirements. Configured 100+ tests, many of
    which contained dynamic reference ranges and complex calculations.
  • Created risk-based models for requirements gathering, bug fixing
    and functionality deliverables.

2012 – Present: SimpleLims Software. VP of Compliance

  • In charge of reviewing and developing Business Associates
    Agreements, Platform security architecture, and HIPAA-compliance white
    papers.
  • Supervised User Interface and User Experience design decisions
    for anatomic pathology LIMS product.

2011 – 2012: VantagePoint Laboratory Partners, Inc. Director of
Compliance and Quality Assurance, San Diego, CA

Role – Compliance Officer

  • Successfully transferred CLIA license for moderate and
    high-complexity testing for two laboratories, changing owners, lab
    directors and addresses.
  • Collaborated with CFO and CEO to create and implement a corporate
    compliance program
  • Medicare (Palmetto) enrollment documentation
  • Medi-Cal enrollment documentation
  • Florida lab licensing application
  • Enrolled in County Fire and hazardous materials and waste and
    radioactivity licensing

Role – Quality Officer

  • Created and implemented a quality plan for a 10-department
    clinical and esoteric lab of moderate and high-complexity
  • Created and implemented a safety plan, obtained hazardous
    materials permits and radioactive materials general license
  • Created, collaborated and reviewed validations for FDA-approved
    tests as well as lab- developed tests
  • Developed quality systems for intra-laboratory processes in
    collaboration with the VP of operations
  • Successfully implemented a document management and training
    system for a 10- department clinical and esoteric lab of moderate and
    high-complexity

Role – Applications Specialist

  • Schuylab LIS admin and super user charged with maintaining test
    menu and interfacing of LIS with various instruments
  • APVx LIS admin and super user charged with troubleshooting code
    and report generation
  • Rapidly implemented MasterControl document management system with
    little assistance from vendor or IT team. Appeared in MasterControl
    marketing piece as a result of successful deployment
  • Xifin billing system super user charged with test creation, CPT
    code assignment and fee schedule generation

2011: Veracyte, Inc. CLIA Lab Supervisor-Molecular, South San
Francisco, CA

Role – Department Supervisor

  • Establish Quality control, quality assurance, and quality
    improvement procedures
  • Interviewed, hired, train, and managed entire CLS and non-CLS
    technical staff
  • Lead process improvement and efficiency efforts in both technical
    and nontechnical aspects of the laboratory
  • In charge of reagent and consumables ordering and inventory
    management and forecasting
  • Review quality documents and SOPs
  • Integral in the creation of a CLS training facility licensed by
    the state of California

Role – CLS

  • RNA extraction, cDNA synthesis, linear amplification, and
    microarray hybridization for gene expression profiling
  • Direct and constant supervision of non-CLS staff for doing
    qualitative and low- complexity testing procedures
  • Perform high-complexity testing in accordance with established
    standard operating procedures
  • Lead investigative studies for process development and process
    improvement

Role – LIMS Supervisor

  • Lead efforts for gap analysis and system requirements creation
  • Create software validation protocols, design testing and release
    plans
  • Developed R scripts to parse all of the lab’s Excel-formatted lab
    workbooks and transferred to a unified database for querying, reporting
    and data migrating to a new LIMS

2007- 2011: Expression Diagnostics (XDx). Senior Clinical Lab
Scientist, Brisbane, CA

Role – CLS/ General Supervisor

  • Phlebotomy and preparation of both clinical and non-clinical
    patient samples
  • RNA extraction, cDNA synthesis, and QPCR expression profiling for
    detection of acute cellular rejection in heart transplant patients
    (AlloMap®)
  • Lead investigative studies for process development and process
    improvement
  • Improved quality control (QC) and quality assurance (QA)
    procedures by implementing Microsoft Access® databases and streamlining
    data analyst procedures in Microsoft Excel® workbooks
  • Designee of Laboratory Director for review quality documentation
  • Part of two-member team that successfully performed a gap
    analysis for CA and NY State, CLIA and FDA regulation and guideline
    compliance
  • Assistant Project Manager for Patient Service Center Site
    Development as a part of a company-wide core team that opened 9 PSCs
    around the country. Interviewed and trained phlebotomy staff.
  • In charge of staff training, equipment and supply ordering and
    installation, and ensuring facility compliance with OSHA, CLIA, state
    and local regulation.
  • On several occasions, negotiated contracts with suppliers, moving
    companies and custodial services

Role – LIMS Analyst

  • Part of a company-wide core team that developed and implemented
    StarLIMS® laboratory information system.
  • Completed StarLIMS® implementation training course and wrote the
    Lab User Guide
  • Assisted implementation consultant with module creation, testing
    and workflow development
  • Super User and LIMS Analyst for the reference laboratory
  • Developed SQL queries and Crystal Reports for Management and
    Executive team regarding test performance, sales and quality
  • Spoke at StarLims national meeting for successful implementation
    in a clinical laboratory

Role – Bioinformatics Specialist

  • Designed a novel algorithm for splice junction probe generation
    for DNA expression microarrays.
  • Helped in the design and development of a novel microarray chip
    for use in whole blood gene expression studies (BloodChip)
  • Researched and analyzed microarray data from publicly available
    published as well as internal work
  • Consulted with members of the informatics and bioinformatics
    teams on special projects

2006-2007: Quest Diagnostics Clinical Laboratory, Molecular
Microbiology Dept. Clinical Lab Scientist, Nichols Institute, San Juan
Capistrano, CA

  • RNA extraction, amplification, sequencing, and genotyping of
    HIV-1
  • Viral Extraction using MagnaPure LC system
  • Amplification using RT-PCR and nested PCR techniques
  • Sequencing analysis using ABI 3730 XL system and Sequencher data
    analyzing program
  • Competent in the use and maintenance of Protedyne Bio-CUBE super
    robot
  • Assist in the validation and implementation of new and improved
    processes
  • Assisted in troubleshooting and QC using UNIX-based HIV sequence
    database and ClustalW software, which included phylogenetic tree
    generation and genotyping.
  • Create original drafts of improved/streamlined Standard
    Operations Procedures for software operation, under direction of
    Scientific Director

2004-2005: Quest Diagnostics Clinical Laboratory, Molecular
Genetics Dept. Lab Associate II,Nichols Institute, San Juan Capistrano,
CA

  • Genomic DNA extraction, amplification, and detection for various
    hereditary diseases
  • Extraction platforms include Qiagen 9604 and Genovision M96
  • Amplification using MJ-Research and ABI thermocycler systems
  • Detection using southern blot, AFLP, RFLP, OLA, Read-it,
    SNaPshot, and capillary sequencing
  • Served on Automation Committee Board and assisted in several
    Green Belt Projects
  • Created and edited Liquid handler methods for pre-analytic
    processes
  • Assisted in the phasing in of new equipment and procedures

Interests and Activities

  • Four-year varsity member of the Bucknell University football team
  • Winner of Christy Mathewson Award for best defensive back
  • Black Belt and world tournament champion in Isshinryu and
    Shuri-te karate
  • Spent summer 1996 and spring 2001 semester in France as an
    exchange student
  • Teach and perform Argentine Tango around the country

References

Available upon request