Jim Bierle Email & Phone Number

Pleasanton, California, Us

• Developed the NGS-based Onyx™ Barcode Diversity Assay to assess library diversity in both E. coli and S.Cerevisiae. Demonstrated assay performance with respect to precision, accuracy, and limit of detection.Worked with operations to develop packaging, critical parameters assessment and shelf-life testing.Validated first customer lot of reagents. Worked with technical writing & Illustrator to develop customer facingprotocol, quick start & troubleshooting guides.• Led commercialization efforts to document and verify the Onyx™ gDNA extraction protocols for E. coli and S. Cerevisiae. Worked with technical writing and Illustrator to provide customers with written protocol andtroubleshooting guide.• Developed the Onyx™ Control Edit Assay to confirm successful genomic edits by the Onyx™ instrument.Included assay development and performance characterization: LOD and controls concordance. Worked withtechnical writing & Illustrator to develop customer facing protocol.• Demonstrated a novel enrichment-based edit detection strategy that used multiplexed CRISPR gene editingcassettes as enrichment probes. Wrote SOP, trained internal staff and released in document control.• Developed a multiplexed CRISPR gene editing cassette manufacturing process for pooled microbial genomeediting. Documented process and transferred to development/operations for further optimization. Completedvendor evaluation from technical, cost, turnaround time and strategic fit perspective.• Developed a CRISPR prime editing cassette manufacturing process for mammalian iPSC editing. Convertedpooled array-based oligos into individual editing cassette isolates. Developed NGS-based assays for cassetteand plasmid quality assessments.

San Diego, Ca, Us

• Managed cross functional team including Software Product Owner and Software Project Management. Transformed the Product Owner function from a reactive to a leading role managing the overall product backlog and requirements for 4 agile scrum teams. Improved overall team productivity and predictability. Supported department transition to Scaled Agile Framework 4.0 and led the product owner team through multiple quarterly planning increments.• Led cross-functional Core Team that delivered Illumina SeqLab to market. A fully-integrated population-scale whole human genome sequencing solution enabling HiSeq X customers to maximize quality, throughput and cost in pursuit of the $1,000 genome. Partnered with GenoLogics and Hamilton Robotics to provide this streamlined end-to-end solution.• Led transformation of BaseSpace Sequence Hub into a factory-scale, sample-centric sequencing analysis platform including automated yield dependent secondary analysis and genome build pass/fail enabling, for the first time, a commercial “manage by exception” factory solution for whole genome sequencing. Coupled with SeqLab, these BaseSpace improvements are enabling Illumina to deliver the 100,000 genomes to Genomics England and Helix to rapidly enable personal genomics. This work has also laid the foundation for Illumina’s Population Sequencing initiatives.• Core Team member representing Enterprise Informatics software deliverable on the NovaSeq instrument development project. Successfully delivered integrated enterprise software solutions for run setup, fastq generations, LIMS workflows and BaseSpace integration for instrument health monitoring, run monitoring, and secondary data analysis.

San Diego, Ca, Us

• Built and managed diverse cross-functional team of Software Systems Engineers, Automation Systems Engineers, Project Management and Software Support. Responsible for development and maintenance of all Illumina Laboratory Information Management Systems (LIMS) and liquid handling automation platforms (Freedom Evo & Hamilton Star) used to manufacture Illumina products.• Successfully executed three major reorganizations (department merger, product line management structure and corporate business units) while maintaining project deadlines by developing transition plans, communicating rational and value of new organizational structure and focusing the new teams on goals and tasks. • Developed and led a change control board for the Software Engineering and Automation department optimizing resource allocation, improving allocation visibility and providing better service for software change requests.• Core Team member on multiple teams. Responsible for LIMS, automation and system integration bringing new products and feature to market. As a core team member, responsible for scope, resources, schedule and quality. Core Team member on teams delivering: TruSeq Exome Enrichment kit, Human HT-12 v4 Expression BeadChip, 2x250bp Miseq read lengths & on boarding Camstar MES for reagent manufacturing.• Lead team delivering LIMS and Analysis Information Management System (AIMS) solutions to manage Illumina’s internal whole genome sequencing services operations in the US and Europe. Led cross-functional team in collaboration with lab staff to deliver an end-to-end factory solution from gDNA input to genome build QC and delivery.

San Diego, Ca, Us

• Built a team of Systems & Automation Engineers and was responsible for oversight of all of Illumina’s manufacturing LIMS and lab automation including system requirements, testing, deployment and production support. Hired, coached and trained staff.• Core team member responsible for the successful launch of the Sentrix™ Array Matrix. Responsible for product management, requirements, unit and system testing and continued production support for Illumina’s high volume LIMS for Sentrix™ Array Matrix and BeadChip manufacturing. This fully-integrated demand-driven system supports globally distributed (San Diego and Singapore) manufacturing and operates 24/7. Integrates five different custom instruments, 8 tip liquid handlers, two “poller” data processing applications and a label printer. The system was designed to be flexible in site location, array content and density enabling Illumina to rapidly launch new products without major system upgrades.• System Engineer responsible for requirements elicitation, unit and system testing and production support for Illumina’s LIMS to manufacture oligonucleotides. This was Illumina’s first commercial manufacturing system and is still in use today to manufacture Illumina oligos. This mission critical high-throughput order to ship three tier system operates 24/7, integrates with an ERP system, custom synthesis hardware, 8 & 96 tip liquid handling robots and quality monitoring instruments to make up to 20 million oligos annually.• Responsible for successful development and deployment of a LIMS to make VeraCode™ beads in support of the BeadXpress™ platform. Responsible for project management, requirements elicitation, unit and system testing and support. This LIMS development was critical to successfully transferring the technology from an acquired company to Illumina.

San Diego, Ca, Us

• Successfully screened address sequences resulting in the set of universal probes used in Illumina’s first commercially available GoldenGate Genotyping product and subsequent Beadchip technology.• Co-developed the 1st generation microarray decoding process and transferred it to manufacturing.• Co-developed the process to make complex “Decoder” pools including high throughput oligo purification, pooling and labeling. These “Decoder” pool reagents enable Illumina to efficiently decode random arrays which is fundamental to Illumina’s microarray technology.

San Diego, Ca, Us

• Key role in the development of Byetta® (exenatide): Executed GMP stability testing of bulk drug substance and final drug product. Performed quality control release testing of bulk drug substance, final drug product and final placebo product. Developed, wrote SOP’s and validated analytical HPLC methods to quantitate and characterize Byetta®• Executed metabolism studies (ADME) supporting Symlin® (pramlintide) regulatory approval, involving methods development, sample extraction and HPLC fractionation and characterization (including immunoassay, chromatography and mass spectrometry.)• Developed a plasma mimic as a matrix for plasma assay standards in Byetta® (exenatide) and Symlin® (pramlintide) immunoassay testing. Developed immunoassays (IEMAs, IRMA, and RIA) against peptide antigens including two validated immunoassays (IEMAs), one for Symlin® (pramlintide) and the other for the human hormone, amylin.• First to isolate and structurally elucidate natural forms of pancreatic and circulating glycosylated amylin, a human hormone.• Evaluated assay detection systems (chemiluminescent, fluorescent, radiometric and enzymetric) to improve assay sensitivity and throughput.

Executive Perspective For Scientists & Engineers (Epse)

Bachelor Of Science, Biochemistry & Cellular Biology