Senior Director of Operations

Responsible for all aspects of manufacturing, supply chain, product technology transfer, logistics and distribution. Full
oversight responsibility for all 3rd party contract manufacturing organizations (CMOs) and service
providers. Oversee, and negotiate all supply and service agreements with external vendors. Responsible
for the full 21CFR820 and ISO 13486:2016 compliance of all operational teams.
? Led the full buildout, implementation, and FDA registration, of a cGMP manufacturing facility.
? Developed and implemented the global 3PL distribution and logistics strategy.
? Key team member on the IVD NPI new product introduction team (C. diff)

Led the manufacturing, purchasing/planning, inventory management, logistics, environmental health and safety, global service and support, and facilities departments. Managed the EU service and support team.
? Led startup of the IVD Global Service and Support team spanning the EU (6 European employees).
? Oversaw the full technology transfer of life science RUO business to Merck Millipore (Acquired 2015).
? Reduced clinical laboratory operating inventory 24% implementing a LEAN approach.
? Negotiation of a new logistics contract saving over $562k per year on priority shipping.
? Implemented outsourcing of blood collection kit manufacturing operation; resulting in $210k /yr savings.

Director of Operations & Supply Chain

Responsible for the manufacturing departments (reagents and instruments). Responsible for the efficient
technology transfer of products from the R&D group into the manufacturing organization.
? Achieved a 20% increase in antibody conjugation efficiency by eliminating non-value added activity.
? Led a facility validation, and move to a newly constructed 50,000 sqft laboratory (Jan. 2013)

Associate Director of Manufacturing

- Oversaw and managed the day-to-day activities of both the Manufacturing and QC laboratories.
? Successfully managed a complete laboratory facility transfer (St. Louis, MO to Alameda, CA).
? Authored 400+ SOPs and Work Instructions supporting the buildout of the Quality Management System.

Production Manager

Supervised a department of Quality Control chemists. Responsible for the quality control testing and product release of diagnostic medical devices and reagents, including incoming raw materials.
? Successfully led an organization wide spreadsheet validation project.
? Served on a LEAN Manufacturing Project Team reducing overall product lead times by 4 days.

Quality Control Supervisor

Supervised a department of chemists in the manufacture of autoimmune EIA diagnostic kits and reagents.
Responsible for meeting final kit quality, customer service level, regulatory compliance, and cost
objectives.
? Managed department personnel and facility transfer (West Sacramento, CA to Hercules, CA).
? Maintained 100% customer service level since facility transfer; March 2005.

Production Supervisor

Acted as team
lead for a department of Chemists, manufacturing autoimmune EIA diagnostic kits and reagents. Traveled with sales and marketing personnel to customer sites to serve as a technical expert and trainer.
? Managed production line scale up from 40,000 kits to 110,000 kits per year.
? Completed design verification testing for 6 new assays leading to 510k submission.

Lead Chemist

Find out detailed information about Noel Fruchtenicht, Senior Director of Operations in Concord, CA

Noel Fruchtenicht: Senior Director of Operations in Concord, CA

Noel Fruchtenicht

Singulex Inc

Singulex Inc

Singulex Inc

Singulex Inc

Bio-Rad Laboratories

Bio-Rad Laboratories

Helix Diagnostics

University of California

University of California