John E. McLaughlin

*** *. **** ******

Philadelphia, PA 19130

Senior Technical Writer/Analytical Chemist

Education/Continued Education

Degree / Major

University

Years

BA/Chemistry

Bloomsburg State University

1974-1977

AS/Biochemistry

Spring Garden College

1972-1974

Academics

St. Joseph’s Preparatory High School

1968-1972

Work Experience

Date from – Date to

Organization and address

Title

01/2016 – 10/13/17

Frontida BioPharm, Inc. 1100 Orthodox Street

Philadelphia, PA 19124

Senior Technical Writer

Creation/Design/Maintenance of written protocols; SOPs; Training /Auditing / prepare sample kits / Review Results / Enter data in PharmaReady for final Dossier / Provide quality support for Validation Documentation.

Collect/Review Equipment / Product Results Forms / Enter in PharmaReady Data Base;

Added New Skill Mater Control (QMS)

Monitor / Sampling Air for Rooms / Corridors; Swab Equipment Surface Areas. Check Expiration date for Swab Vehicle, etc. Maintain Sample Kit Containers; Solvent Cabinet; and Clean Production.

12/2008 – 01/2016

URL Pharma (Sun Pharma) 1100 Orthodox Street

Philadelphia, PA 19124

Senior Technical Writer

Creation/Maintenance of written protocols; SOPs; Training/Auditing/Prepare sample kits/Review Equipment/ Product Results/ Enter Data in PharmaReady for final Report/ Provide quality support on Validation / Cleaning Studies Documentation; Added PharmaReady Server for storage of Reports/Results

Collect/Review Equipment / Product Results Forms / Enter in PharmaReady Data Base;

Monitor / Sampling Air for Rooms / Corridors; Swab Equipment Surface Areas. Check Expiration date for Swab Vehicle, etc. Maintain Sample Kit Containers; Solvent Cabinet; and Clean Production.

12/2002 – 12/2008

URL/Mutual Pharmaceuticals 1100 Orthodox Street

Philadelphia, PA 19124

Compliance Investigator/ Auditor

CAPAs Documentation for entry in Track Wise - Assigned to investigate notebooks for OOS results /

back-dating, blank spaces, incorrect documentation / Check for expired secondary standard / solution prep.

GMP Training (SOPs) of new employees with lab demos; effective demonstration, challenge associates in Documentation, Written / Solution Preparation / Calculations / Safety (cGLP)

05/2001 – 12/2002

Mutual Pharmaceuticals 1100 Orthodox Street

Philadelphia, PA 19124

QC/ARD Lab Auditor

Responsibilities included: Review all associates’ notebooks; Preparation of Mobile Phases Logbooks / Dilutions / Test Solution books; Check calculations for potency/ Safety Requirements: (cGLP).

11/2000 - 05/2001

Rohto Mentholatum Research Lab 111 Rock Road

Horsham, PA 19044

Chemist

Laboratory Responsibilities / Skills included: Improvement of HPLC Analysis Method Development with Finished Product (Topical)/HPLC & GC – Operation / Maintenance and Calibrations.

06/1997 – 10/1999

Johnson-Matthey

2003 Nolte Drive

Paulsboro, NJ 08066

Stability Chemist

Responsibilities / Skills included: Operation / Maintenance and Calibrations of Instruments

HPLC Analysis of all APIs / Excipients – HPLC / GC / Safety Requirements: (cGLP).

07/1996 – 06/1997

Global Pharmaceuticals

3700 Castor Avenue

Philadelphia, PA 19124

Senior Scientist

Stability Supervisor

Manager

Laboratory Responsibilities/ Skills included Analysis of APIs / Assay / ROI / LOD/ ID (by FT-IR) / pH / Titrations / Particle Size of Raw Materials / Responsibilities & Skills included: Operation/Maintenance/ Calibrations of Instruments: HPLC / GC / UV/Visible / Dissolution / Stability/Finished-Product/ Responsible for the coordination of the pulling and analysis of stability samples. Safety Requirements: (cGLP)

.

05/1984 – 07/1996 SmithKline Beecham Labs Analytical Chemist

1500 Spring Garden Street

Philadelphia, PA 19130

Laboratory Responsibilities and skills included Assay Analysis on APIs / Excipients – USP/ In-house MOT

/ Preparation of all Test Solutions / ROI / LOD / ID (by FT-IR)/ pH / Titrations / TLC / Particle Size of Raw Materials. Operation / Maintenance/ Calibrations of Instrumentation: Preparation of all Mobile Phases for HPLC / GC / UV/Visible / Dissolution / Robotics / Atomic Absorption / Electrophoresis – SDS-PAGE / Intermediates – Bulk Blends / Stability/ Finished Products (Tablets/Capsules)/ Improvement of Method Development / Method Validation/ Safety Requirements: GLP

Areas of Expertise: Chemist/Auditor

Detail-oriented: Discovered API’s Identification solution incorrectly prepared / Inconsistent Test Results /

Results-oriented: API’s Potency calculation / Method incorrectly set-up / Inconsistent Test Results reported//

/ Analyst used Expired Secondary Standard.

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