Stephen Schulz Email & Phone Number

Managing process development and CAP/CLIA certified lab operations involving oncology diagnostics and drug MOA studies. Streamline and reduce process variance in cell culture and analysis operations. Maintain and improve quality systems. Develop functional cell based assays.

Chelmsford, Ma, Us

Novel fluidic diagnostic device and manufacturing process development. Design, prototype, and troubleshooting of injection molded fluidic components. Developed and implemented novel assembly tooling and processes for disposable fluidic cartridges containing lyophilized reagent beads. Modified instrumentation hardware to adapt to improved consumable design. Implemented new manufacturing space and managed manufacturing team.

• Lead a matrixed team to prioritize and implement process improvement activities.• Develop and strengthen manufacturing processes for large scale microfluidic diagnostic consumable. Microfluidics, embossing, electrode formation, equipment design/selection.Increased tool life ~5x, electrode first pass yield ~2x, particle reduction ~3x.

• Coordinated multi-vendor design of a complex, inkjet based system to synthesize DNA oligos in a massively parallel format. Activities include system development, integration, and testing.• Developed novel fluidic architecture and patterned/coated substrate directed at oligo synthesis yield.• Reduced gene assembly COGs ~40% via process step and reaction volume reduction. Developed 384 automated processing scripts. PCR optimization, ligation, purification, analysis. Improved yield through guard banding activities.

• Originated a novel microfluidic system and consumable to automate a proprietary therapeutic small molecule discovery process based on DNA tagged libraries. Created a commercialization plan and supply chain. Developed UI and multistep control algorithm. Analysis/QC NGS/fluorescent read.• Supported BD activities for acquired label free platform.• Improved yield and accuracy of NGS results applied to discovery of anti-body therapeutics against cell surface targets by improving library preparation methods and data analysis. Primer design, size purification, protein quantification.

Us

• Lead a proactive, multi-disciplinary department responsible for development and manufacturing of low cost, consumable optical biosensors for high throughput label-free and amplified fluorescent IVD applications. Moved the organization from an empty floor to volume commercialization.• Communicated platform capital plan and cost structure to commercialization partners.• Implemented supply chain and improved vendor capabilities.• Evolved optically resonant sensor design to towards performance and manufacturability.• Developed novel, automated roll to roll manufacturing equipment. • Technical operations included:Roll to roll nano replication, optical sputter coating, lamination, UV cure.Pick and place assembly, precision bonding. Custom injection molded parts.Automated liquid handling and micro dispensing. Machine vision cutting and defect capture.Plasma surface treatment. Surface chemistry production and optimization.Protein and cell based assay development. Cell migration, health, pathway stimulation.• Established LEAN process flow and a fully traceable quality system based on ISO13485 including web based access to ~200 SOPs. • Sourced & modified raw materials. Established shelf life, packaging, and shipping requirements.• Employed and trained others to use 6S tools including DOE, SPC, FMEA, DMAIC cycle.

Developed, designed, and executed 1st and 2nd generation, high volume, sol-gel spray coating equipment for touch screen wear and antiglare coatings. Implemented new production operations on a live manufacturing floor to ISO9000 standards. Trained and supervised manufacturing personnel.Initiated successful programs to fundamentally reduce the capacitive sensor cost base. Collaborated with suppliers to transfer optical and functional layer manufacturing from vacuum coating to APCVD.Prototyped and developed novel flexible sensor products. Flex capacitive, hybrid, ITO top-sheet. Eliminated costly outsourcing of coating for large area curved touch panels.Mentored associates and responded to customers.

Faribault, Mn, Us

Innovated and scaled up processing methodologies for production of thin-film, electro-chromic window (battery) technology.Developed control and testing methodology for electrochromic window technology.

Developed equipment and sputter process technology for production of large area, optical coatings.Installed "first-of-kind" in-line anti-reflection coating equipment in Japan.

Dearborn, Michigan, Us

Produced the first, full size electrochromic moon-roof prototype.

Ms, Electro Optics

Bse, Engineering Physics