Training High School

Resume: Jonathan J Louden

Jonathan J Louden

***** ********* ****, ****** **** 44021

Phone: 216-***-****

E-mail: **********@*****.***

Quality oriented Sr. Chemist/Department trainer with expertise in employee supervision and

development, quality process training, method remediation, method validation, and site

closure.

Education

B.A. Chemistry, Kent State University (May 1998)

Six Sigma Yellow Belt (Cuyahoga Community College)

Edgewood High School Graduate (1993)

Professional Experience

Ben Venue Laboratories, 1998-Present

Department Trainer/Senior Chemist, Analytical Services/Site Closure Team: (Current Role)

(Trainer) Large hiring required role for FT Department Trainer. Supported all department training, new

and ongoing, for department of >100 individuals. Responsible for tracking all training activities within

the Plateau learning system and direct supervision of all new hires during introductory period (8-10

wks). Direct audit contact for all QC customer and FDA training request. Served on the Consent

Decree Remediation Team for all Site Training Requirements.

(Senior Chemist, ASG) Evaluation of new and existing methodology supporting current and new

product submissions. Developed Gap assessments to remediate methods to current USP/EP/ICH

requirements. Complete method validation (Protocol Generation to Final Report) for HPLC, UV, KF

and other cGMP methodology.

(Site Closure Team) Support of department decommissioning per cGxP requirements. Work currently

includes instrument final script and qualification performance, log and inventory of applicable

instruments and equipment, testing of remaining site utility systems (WFI/Nitrogen), testing of product

Stability time points, and transfer of existing methodology to outside laboratories.

Final Product Supervisor: Supported release of finished goods COA based on analytical testing

obtained within the QC chemistry and microbiology laboratories. Supplied timelines and expectations

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Resume: Jonathan J Louden

to supporting departments for scheduling release and shipment of product. Managed the Final Product

investigation/deviation system. Managed a team of up to 8 analysts for support of Finished Products.

Methods Transfer Chemist/Trainer: Supported incoming customer products to the Quality Control

Laboratory. Responsible for all new incoming customer testing and methodology transfer to the QC

laboratory. Selected and trained new hires for work in the QC laboratory and migration into testing

groups. Responsible for department new and ongoing training processes.

Temporary Chemist Through Chemist II: Supported Finished Product Testing, Stability Testing, and In

Process Testing of Liquid and Lyophilized Sterile Injectable products.

Moen, May 1998-July 1998

Temporary chemist testing faucet run off by ICP analysis.

Committees/Accomplishments

Boehringer Ingelheim Reach Award winner (Platinum, Gold, Bronze levels)

Consent Decree Remediation Team 2013

cGMP committee (charter member-2010-2012)

Ben Venue Corporate Training QES 2008-2010, QC Training QES chair, 2009-2010

Spill Response team, 2008-2010

Connect with Leadership 2009

Example Work Accomplishments:

1) Current methodology for a release product did not have a fully validated method for Assay of

active ingredient. Specified product was tested by Ion Chromatography due to lack of strong UV

absorption at acceptable wavelengths. Ion Chromatography for this product was not robust and

issues with precision and other analytical factors created delays, investigations, and sporadic trend

lines, requiring method evaluation. Research determined that compendia for the EP specified an

impurities test for relatives to the active ingredient. This testing utilized tagged derivitization of

primary amines to allow for UV analysis under typical HPLC parameters. EP Compendia

methodology was leveraged to develop a robust method for Assay of this ingredient which was

fully validated, submitted and approved for use in the QC release laboratory. The resulting

validated method has eliminated unneeded investigation, improved trending ability, and quickened

release time for chemistry testing.

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