Michael Melofchik

Spotswood, NJ 732-***-****

acdr01@r.postjobfree.com

Linkedin.com/pub/dir/Mike/Melofchik

SCIENTIST

Analytical Scientist experienced with diverse technologies and techniques.

Skilled in servicing the needs of multiple manufacturing and research site

small molecule chemical distribution including shipment, business document

control, while maintaining confidentiality and integrity. Experienced in

Fortune 500 business practices and establishing the reputation of mid-sized

contract laboratory operations.

PROFESSIONAL EXPERIENCE

Merck / Schering Plough Pharmaceuticals / Organon (Summit / Union, NJ)

Scientist - ACDS-SAS 2009 -

Present

Integrated new reference standards testing program for Global sites during

merger of Schering-Plough and Merck.

. Supervised transfer of approximately 300 materials, including

packaging, and inspection.

. Furnished data to regulatory agencies regarding structures of

compounds and testing results.

. Encouraged the re-scheduling of reference standards with similar

analytical methodology to minimize solvent and resource waste.

. Interpreted and coached colleagues on industry publications and

testing methods, USP/EP/JP.

. Assisted in implementing the use of 5S laboratory standards.

. Recognized potential impediments in laboratory testing operations and

coached less experienced staff through barriers.

. Evaluated small molecule API's, and excipients from multiple vendors.

Minimized and condensed testing methods.

. Maintained and integrated reference standard monographs obtained from

multiple. manufacturing and research sites.

Laboratory Analyst / Technical Specialist - Global Quality Analytical

Sciences 2009 - 2007

Facilitated new compounds from the merger of Schering-Plough and Organon

pharmaceuticals. Undertook additional responsibilities due to corporate

reorganization.

. Assisted in the sourcing, archiving and maintenance of all historical

reference standard monographs obtained from multiple sites.

. Required to review and implement current DOT regulations regarding

shipment of reference materials.

. Responded to customer requests and technical questions from >200

sites, including assisting of training of colleagues of the modernized

business model of global centralized requesting.

. Maintained and interpret current shipping requirements including Bill

of Lading forms, Pro-Forma invoices, and MSDS.

. Fill out work requests and change authorizations. Coordinate sample

testing with new members of Reference Standard team.

. Evaluated and selected vendors for the packaging and shipment of small

molecule pharmaceutical API's, excipients, degradants and impurities.

Analytical Chemist / Technical Specialist - Global Quality Analytical

Sciences 2007 - 2003

Evaluate and troubleshoot new and current analytical methods coming into

the laboratory. Investigated technical problems in laboratory.

. Overhauled and launched CFR Part 11 compliant software (Cambridge

Reference Standards Management System) for inventory tracking.

. Built storage area for quarantined materials awaiting testing.

. Tailored training program to ensure systematized training throughout

organization of 50+ colleagues. Sourced materials for analysis to all

global sites.

. Assisted in instrument installations, qualifications, and

calibrations.

. Reviewed and revised SOP for instrument IQ/OQ/PQ. Implemented

successful integration to colleagues.

. Introduced and integrated new SOP for Controlled Drug Substances and

List I Chemicals.

Associate Analytical Chemist

2003 - 2000

Perform current in house sample testing.

. Diagnosed and identified gaps in new and current methodology

to ensure reproducibility and compliance.

. Corresponded with vendors of instrumentation and materials to

assess problems and determine solutions.

. Trained in analytical techniques for small molecule analysis such as

UV/Vis Spectrophotometry, Fluorescence Spectroscopy, GC, HPLC, TLC,

Viscosity testing, FTIR, Potentiometric and Manual Titrations, Karl

Fischer Water analysis.

. Executed evaluation studies and cGMP method transfers, tabulated

results and influenced management on successful implementation

strategies.

Quantitative Technologies, Inc. (Whitehouse, NJ)

Senior Laboratory Technician

2000 - 1999

Develop non-GMP and GMP methods for metals analysis for client supplied

samples. This includes sample preparation and analytical (instrumentation)

techniques.

. Worked on GMP method developments, validations and performance.

. Interpreted and analyzed analytical results generated from the

laboratory.

. Standardized result reporting through label templates for more

efficient management review.

. Assisted in performing IQ/OQ/PQ on laboratory instrumentation to

ensure Y2K compliance.

Laboratory Technician 1999 -

1998

Perform testing on more challenging compounds. Updated and revised in-

house SOPs. Ensured technical accuracy and reproducibility for non-GMP and

GMP applications. Perform instrument calibration.

. Qualified on Polarimeter for chiral identification and quantification

of small molecules.

Associate Laboratory Technician

1998 - 1998

Perform and document testing as per cGMP guidelines. Order laboratory

supplies, and update spreadsheets for result reporting.

. Trained on wet chemical techniques for trace metal analysis such as

wet chemical digestion, organic matrix dissolution for analysis, high

pressure microwave digestion, refluxing, high temperature fusion, and

muffle furnace ignition.

. Qualified on instruments and software used for trace metal analysis,

Inductively Coupled Plasma, Flame Atomic Absorption Spectroscopy,

Graphite Furnace Atomic Absorption Spectroscopy.

EDUCATION:

The Pennsylvania State University, University Park, PA

BS Physical Science August 1997

Brookdale Community College, Lincroft, NJ

Business Entrepreneur Certificate Program June 2005

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