Noel Fruchtenicht Email & Phone Number

Livermore, Ca, Us

Direct leadership of all revenue-generating operations including all manufacturing and laboratory departments.

Concord, California, Us

Concord, California, Us

Directed the manufacturing, supply chain, product technology transfer, and environmental health and safety departments. Managed the full oversight of 3rd party Contract Manufacturing Organizations (CMOs) and service providers. Drove the full 21CFR820 and ISO 13485:2016 compliance of operations personnel and procedures.• Led the build-out, validation, and FDA registration of a 25,000 sq. ft. cGMP reagent manufacturing and quality control facility, including all associated equipment.• Managed and negotiated all supply and service agreements with external vendors. • Developed and implemented the IVD global 3PL distribution and warehousing strategy.

Led the manufacturing, supply chain, facilities, environmental health and safety, and technical support departments. Oversaw and managed the European based Global Service and Support Team of 6 employees across 5 countries in the EU.• Led the startup of the IVD Global Service and Support team spanning the EU. • Oversaw the full technology transfer of the life science RUO business to Merck Millipore after their June 2015 acquisition of our technology for the RUO field of use.• Reduced clinical laboratory operating inventory 24% by implementing a LEAN approach.• Negotiated a new logistics contract saving over $562k per year on priority overnight shipping.• Implemented outsourcing of blood collection kit manufacturing operation, resulting in $210k/year savings.

Directed the manufacturing departments, both reagents and instruments. Oversaw and directed the implementation, development, and maintenance of manufacturing methods. Drove the technology transfer of products from R&D into the manufacturing organization.• Achieved a 20% increase in antibody conjugation efficiency using LEAN methods.• Led a facility move and validation of a newly constructed 50,000 Sq. Ft. lab (Jan 2013)• Implemented a cGMP compliant equipment calibration and maintenance program for the manufacturing and quality control laboratories.

Led the start-up of a high mix / low volume manufacturing operation. Oversaw and managed both the manufacturing and quality control laboratories and personnel. Drove the successful transfer of products from the R&D department into manufacturing and commercial production. • Successfully managed a complete laboratory facility transfer including: cold chain raw materials, equipment, and manufacturing technology. (St. Louis, MO to Alameda, CA)• Awarded the Singulex “Top Performer” award (2009) for driving the manufacturing startup project ahead of schedule and underbudget.• Authored 400+ SOP’s and Work Instructions supporting the buildout of the Singulex Quality Management System.

Hercules, Ca, Us

Supervised a department of 13 Quality Control chemists. Led the quality control testing and product release of Bio-Rad medical devices and reagents, including incoming raw materials. Served as the QC representative on non-conformance investigation teams and material review boards.• Ensured process and final product compliance with the Quality System and ISO:13485 regulations.• Used LEAN techniques to implement a QC workflow change resulting in a 30% decrease in QC release turnaround time.

Hercules, Ca, Us

Supervised a department of 5 chemists and budget of $1.5M in the manufacture of autoimmune EIA diagnostic kits and reagents. Responsible for final kit quality, customer service level, and cost objectives. • Managed a successful department personnel, manufacturing equipment, and technology transfer to the Bio-Rad Hercules manufacturing facility. (West Sacramento, CA to Hercules, CA).• Maintained a 100% customer service level (0 backorders), since the facility transfer in March 2005.

Led a department of 5 chemists, in the manufacture of autoimmune EIA diagnostic kits and reagents. Ensured that SOPs/GMPs were followed and documented. Performed protein purification employing chromatography techniques. Traveled with sales personnel to customer sites to serve as a technical expert and trainer. • Oversaw and managed a production line scale up from 40,000 kits to 110,000 kits per year.• Performed design verification testing for 6 new assays in support of their 510k submissions.

M.B.A., Finance And Operations

B.S., Biochemistry

Green Belt, Lean Six Sigma