Christopher Gardner Email & Phone Number

Chicago, Il, Us

Site leader responsible for manufacturing and process engineering, facilities, EH&S, packaging, and plastic /molded component manufacturing.

Abbott Park, Illinois, Us

Leads the Process Automation Strategy for the Core Lab division of Abbott Diagnostics. Directs a team of automation engineers in the development, implementation, and improvement of high speed automation for assembling, filling, testing, and packaging of injection molded plastic components for Abbott's global diagnostics business. Develops equipment and capital strategy to support the business need for consumable reagent kits of the Alinity and other legacy diagnostic platforms.

Northfield, Il, Us

• Successfully developed, launched, and operated Sodium Chloride for Injection USP compounding operation. Installed and validated new USP Water for Injection system, clean in place compounding operation, and clean fill saline packaging operation with 6 month return on investment.• Conceived, developed, and launched fully automated, high speed syringe filling, sterilization, and packaging operation for pre-filled, injectable combination product in an ISO class 8 clean room. Incorporated best manufacturing practices from years of previous production methods. Doubled the production speed of a single line and combined several operations into a single process stream, reducing required headcount by 80% compared to previous methods. • Generated a five year manufacturing plan to expand production capacity and reduce cost by rolling out new technologies across multiple sites to support long term growth of core product lines.• Rebuilt and re-purposed legacy filling equipment to product bottles of saline and water for irrigation, meeting USP requirements. Incorporated six sigma process development principles to assure 40 year old equipment could provide a robust, reliable and predictable process. Supported 510k clearance of device to allow for in house production.• Re-engineering and re-location of existing form-fill-seal process with clean fill packaging operation for surgical scrub brush with pre-filled skin disinfectant. Upgrade clean room, CIP process, and product handling to reduce high rate of lot rejection for microbial failures. Re-evaluated test methods, stability program, and packaging configurations to extend shelf life of the product. • Hired, trained, and developed high performing manufacturing and engineering team from the ground up for new manufacturing operation to drive a target cost of production of $20MM/yr. • Evaluation of new product opportunities as well as M&A opportunities to expand product offering of the business.

Us

In October 2015, Excelsior Medical was purchased by ICU Medical and Medline Industries and I transitioned to a role with Medline Industries. • Managed complete manufacturing operation and engineering for high volume assembly and packaging operation with a $10 million annual cost of production.• Assumed responsibility for a mismanaged manufacturing operation with 33% scrap and <50% efficiency. Within 6 months, reduced scrap rates to 2% and improved efficiency to greater than 80% OEE on a 24/7, ISO Class 8 clean room operation. • Expanded capacity by 300% and reduced manufacturing cost by 50% over 3 years by building a strong production team focused on quality manufacturing, continuous improvement, and safety. • Directed the intellectual property portfolio for the company resulting in 13 US patent awards and multiple International patent awards, protecting five product families. • Leadership team member responsible for coordinating external legal counsel in the successful defense of US and international patent infringement lawsuits.• Developed advanced syringe design for alternative sterilization methods. Created a premium priced (>50% GM) new product with a value oriented sales proposition to replace a commodity priced (~15% GM) product in a saturated market. • Established portfolio of new product designs, line extensions, and expansion opportunities to create a family of catheter access and maintenance devices to position the privately held company as an attractive asset for a strategic investor. • Core member of company leadership team that helped the private equity ownership sell the company in a successful transaction to two strategic acquirers. Supported the transfer of assets and intellectual property to new owners while maintaining manufacturing continuity, customer support, and continued patent prosecution.

Us

• Designed, developed, obtained 510k clearance, manufactured and launched SwabFlush®, which integrated a SwabCap® disinfecting cap with a pre-filled saline flush syringe to drive product use, increase product compliance, and provide market differentiation. This novel and patent protected delivery system would eventually sell over 50 million units per year and help drive meaningful reduction of hospital acquired blood stream infections.• Developed and launched line of pre-filled catheter lock syringes for central venous catheter disinfection. Used a novel combination of fluids, compounds and excipients to create a new catheter lock solution to both disinfect the internal surfaces of a catheter and keep the catheter patent for extended dwell periods. Cleared the combination product for use in Canada and EU and developed a plan and regulatory path to launch in the US. • Conceived and directed numerous design changes and material qualifications to drive cost savings and product improvements on high volume product family.• Built and developed 7 person product development team responsible for sustaining product design projects across 3 business units, launching disinfecting cap and catheter lock product lines, and implementing cost reductions for base syringes business saving over $2 million dollars annually.

Us

• Designed, developed, obtained 510k clearance, manufactured, and launched SwabCap® disinfecting cap product line. This innovative product offered nurses a low cost way of reliably disinfecting catheter access sites to help reduce central line associated blood stream infections, a major hospital acquired infection, by an average of over 50%. This successful product line would eventually sell over 100MM units per year and win design and packaging excellence awards.• Developed and launched a proprietary syringe design for Excelsior’s pre-filled saline flush product line, allowing the company to move away from using OEM products and instead use clinically focused designs with market differentiating features. Procured and installed four automated manufacturing lines to provide capacity for 250MM units of annual production.• Built design control and risk management system, upgraded design documentation for new and legacy product lines across multiple business platforms, resulting in successful review of these quality sub-systems in 4 FDA inspections, 8 ISO audits and multiple customer quality audits. • Lead several root cause inspections and successful corrective action implementations for product design and manufacturing related issues • Provided technical leadership through 3 product recalls, FDA inspections (including supporting the resolution of four 483’s and 1 warning letter), ISO audits, and numerous customer audits.

• Supported design and development of new syringe products and modifications to current products, including product design, FEA and Mold flow analysis, Product and Process validation, and other activities consistent with FDA design control requirements• Lead cross functional teams on projects for as long as one year and managed capital budgets. Successful projects include the launch of an in expensive needle shield and auto-disable syringes to prevent the spread of diseases in emerging markets through accidental needle sticks and through syringe re-use. • Utilized Six Sigma Black Belt and Lean Manufacturing tools including process flow maps, cause and effect diagrams, critical to quality element tree, measurement systems analysis, hypothesis testing, designed experiments, control charts, and other statistical analysis tools to reduce cost and improve production on high volume manufacturing processes.

Irving, Tx, Us

• Oversaw design control (including development, testing, IQ/OQ/PQ validation, risk assessment, and implementation) for new products, product enhancements, and new manufacturing processes across multiple product lines• Utilized tools such as SPC, FMEA, life cycle testing, and Design of Experiments to ensure continual process stability, reliability, and statistical repeatability• Designed and implemented process improvements and automation to realize cost savings, improve quality, and reduce operator exposure to repetitive motion while adhering to FDA GMP, QSR, and design control standards• Provided technical manufacturing support for various product lines including implantable enteral feeding devices, endoscopic catheters, disposable defibrillator pads, ventilator assistance devices, oral care devices, and stomach flush systems• Initiated product and process improvements to reduce scrap associated with manufacturing• Conducted vendor audits for new and existing suppliers• Investigated customer complaints (including failure analysis) on returned product, provided technical feedback to customers, and initiated CAPA’s based on investigation results

Irving, Tx, Us

• Oversaw the design, fabrication, and installment of multiple features of a nonwovens prototype line• Designed automatic roll change material winder involving variable speed drives, pneumatic and electrical actuators, programmable logic controllers, rack and pinion roll steering devices, and other electro-mechanical components• Integrated features into a complete pilot manufacturing facility while working in a project team consisting of line operators, CAD technicians, engineers, management, general contractors, and equipment vendors• Provided detailed engineering, design, and drafting of electro-mechanical converting equipment to support multiple research teams• Provided engineering support for manufacturing locations to upgrade or replace existing equipment