Chemist

Mitchell Bielanowski

*** *** *****

Middlesex, New Jersey 08846

Home 732-***-**** Cell 908-***-****

Objective: To obtain a Scientist position in a Company with growth potential , which would allow me to use my work experience and education.

Summary of Qualifications

Over 20 years of solid experience in Analytical Chemistry in the Pharmaceutical Industry,

Analytical Method Development and analysis of organic and inorganic compounds.

*Method Development for Toxicology Dose Formulations, Cleaning Validation using swabs and rinses, API and finished products, Drug Metabolism analysis of biological samples.

*HPLC, UPLC, TOC, A.A., IR, UV/VIS, GC, KF.

*Ability to Train and manage subordinate chemist.

*Excellent knowledge of Current GMP, GLP, FDA, DEA, USP, and ICH guidelines.

*Writing Technical Reports, Protocols, SOPs , Training Protocols, Validation Reports.

Experience

September 2010-PRESENT - Real Estate Agent

New Jersey Real Estate Agent , The Referral Group Inc.

Independent Real Estate Agent, Sales and consulting for investment and Residential Properties

April 1992-2010 September - Schering-Plough Research Institute,Kenilworth, New Jersey

Scientist, Analytical Development

*GMP analysis of API and finished products using USP and validated Methods of analysis

*Development of HPLC methods of analysis for Toxicology Dose Formulations.

*Analysis of Toxicology Dose Formulations to monitor Toxicology Studies.

*Method Development of Cleaning Validation and verification assays for swabs and rinses using

HPLC, UPLC, ( Waters and Agilent ) TOC ( GE) and A.A..( Varian)

*Method Development and Validation for GMP testing of API and finished products

*Conversion of HPLC methods to UPLC methods for GMP analysis

*Writing Protocols, Development Reports, SOPs, Validation Reports, Technical Reports.

*Method Transfer from development to offsite manufacturing sites and testing labs.

*Review notebooks and data analysis for testing approval. (Millennium and Empower)

*DEA Controlled Substance representative for the Department.

*Safety Committee member and internal compliance Auditor.

1990-1992 Chemist, Drug Metabolism Wyeth-Ayerst Research,Princeton, New Jersey

*Method Development of Drug metabolism assays using HPLC.

*Analysis of Biological samples to support Drug metabolism studies.

*Designed experiments for the isolation and analysis of glucoronide metabolites

*Writing validation reports and General Technical reports.

*Waters HPLC and TurboChrome Data collection

EDUCATION

Bachelor Degree in Business Management

Kean University of New Jersey, School of Business, Management Science

Union , New Jersey May 2001

Bachelor Degree in Chemistry

Kean University of New Jersey, School of Natural Sciences

Union, New Jersey May 1990

Associates in Applied Science in Medical Laboratory Technology

Middlesex County College, School of Allied Health

Edison, New Jersey May 1985

Professional Certifications by Exam

Project Management Certification

Expert Rating November 2006

Certified Quality Auditor

American Society for Quality June 2004

SIX SIGMA Green Belt

Villanova University September 2004

Technologist in Chemistry

American Society of Clinical Pathologist August 1991

Medical Laboratory Technician

American Society of Clinical Pathologist August 1985

AWARDS AND HONORS

LAMDA ALPHA SIGMA

Arts and Sciences Honor Society of Kean University

Shining Star Performance Award

Schering-Plough Research Institute

Multiple Performance awards for keeping project time lines

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