Senior Scientist Resume Summit, NJ - Hire IT People

SUMMARY

Senior Scientist with over 15 extensive experience in the Pharmaceutical and Healthcare Industries.
Exceptional knowledge in software applications for the pharmaceutical industries. Expertise in chemical instrumentation, biomedical informatics, quality drug analysis and toxicology.
Resourceful team player with strong analytical, project coordination and interpersonal communication skills. Leadership ability demonstrated through development and training of other analyst on Standard Operating Procedures.

Laboratory Techniques and Instrumentation Training

Normal and reverse phase, isocratic and gradient HPLC; GC; thin layer chromatography.
Automated Dissolution System (for normal and extended release solid dosage), hardness, moisture solution chemistry, etc.
FTIR, UV/Vis, AA, TLC Spotter and Scanner, electrolysis and wet chemistry.
LIMS, Turbo Chrome (PE), Empower, Alliance (Waters), HP, computer data and word processing applications, such as Microsoft Office.
Well versed in cGMP's, SOP's and Safety Guidelines at Organon, Schering Plough and Merck
Certificates, Short courses in Chromatography (HPC/GC/TLC) and method development.

EXPERIENCE

Confidential,Summit, NJ May 2008-August 2010 Senior Scientist

Performed GMP analytical testing on drug substance, drug product, raw material and intermediates, monitor ongoing experiments and suggest alterations or solutions to laboratory related issues.
Assisted in planning, conducting evaluating and interpretation of laboratory experiments.
Maintained up-to date training in cGMP, safety and other application regulatory requirements (i.e. USP, Ph. Euro and ICH).
Provided guidance to colleagues and work on multiple projects of different complexity.
Wrote review documents/reports intended for incorporation into IND/NDA submission.

Confidential, Roseland, NJ January 1991 - May 2008 CMC Scientist III (11/04-05/08)

Coordinated method transfer to CMO including supplies from overseas, writing of protocol, execution of method transfer, reviewing data packages from CRO and writing the report of MT for solid, parenteral products and stability testing.
Coordinated investigational product supplies for testing to CMO in US/overseas, includes filling of appropriate forms, arranging with CMO to send samples to the contract facilities for testing, reviewing the data received from contract laboratories and forwarding the QA release to the appropriate department for release of clinical supplies.
Wrote and reviewed stability modules and reports for clinical studies, IND and NDA filing and writing SOP's for clinical supplies.
Prepared method validation package and reviewed of the data for GMP violation.

Senior Pharmaceutical Scientist (07/95-11/04)

Conducted numerous transfers of analytical methods from NVO (Holland) and QC laboratory for various projects (Solids/Parenterals).
Operated, maintained and trained analytical scientists on the operations of Laboratory Information Services (LIMS).
Wrote instructions and SOP's for laboratory use in compliance with the company's wide internal quality system cGMP and other regulatory organizations.
Assisted Team group Leader and managed team of 4 to 5 scientists responsible for in the absence of group leader:

Development and validation of stability indicating assays and cleaning validation methods.
Conducted of stability studies in support of clinical studies, IND and NDA filing.
Wrote up and review of protocols, SOP methods, modules, reports and pertinent documents for inclusion in IND and NDA submissions.
Represented the department on coordination and facilitation teams for department projects.
Conducted development work, reviewed and released analytical data and assured the reliability and quality of information in meeting all internal and external quality standards.
Managed the purchase of laboratory instruments and supplies, prepared budget for the lab and negotiated prices, deals and accounts with suppliers.

Pharmaceutical Scientist (01/01-07/95)

Performed routine stability work for the projects of different classes of drugs (Solids/Liquids).
Validated assay and cleaning methods from overseas for IND/NDA submissions.
Prepare and released supplies for preclinical and clinical studies.
Review/write reports/documents for inclusion in IND and NDA submissions.
Serve as a project team coordinator for specific projects and a member of coordination teams for similar projects.

ADDITIONAL RELAVENT EXPERIENCE Several positions with increasing responsibilities as a Chemist, Analytical Chemist, Quality Control Inspector and Pharmacist Technician

EDUCATION Bachelors of Science, Pharmacy Certificates in short courses (HPLC/GC) in chromatography and Method Developments through Waters, EAS, & ACS Diploma in Medical Laboratory Techniques

PROFESSIONAL AFFILIATIONS American Chemical Society

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Senior Scientist Resume

Summit, NJ

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