Christopher Gardner Email & Phone Number

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.

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.
• 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.
• 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.
• 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.
• 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.

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.
• 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.

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.
• 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.
• 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.

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.
• 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.
• 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.
• 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.
• 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.
• 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.

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.
• Initiated product and process improvements to reduce scrap associated with manufacturing
• Conducted vendor audits for new and existing suppliers

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.
• 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