QA Specialist Manager Director - Biotech Resume Search
QA Specialist Manager Director - Biotech Resume Search
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QA Specialist/Manager/Director Resume


Desired Industry: Biotech SpiderID: 61558
Desired Job Location: North Bergen, New Jersey Date Posted: 6/16/2012
Type of Position: Full-Time Permanent Availability Date:
Desired Wage:
U.S. Work Authorization: Yes
Job Level: Experienced with over 2 years experience Willing to Travel: Yes, 50-75%
Highest Degree Attained: Doctoral Willing to Relocate: Undecided


Experience:
OVERVIEW
Senior Development Chemist and Release Specialist. Have performed these functions at Pfizer, Inc. (formerly Wyeth), Nycomed US Inc. (formerly Altana, Inc.), plus other organizations such as the NYC Police Department, Frutarom, Chromak Research and Castrol North America. Possess Ph.D. and MS in Chemistry and BS in Chemical Engineering. Fluent in English, Russian and Hebrew plus ability in basic German.
Hallmarks:
• Possess extensive experience in Quality Assurance, GMP, GLP, Root Cause Analysis (RCA), and Corrective and Preventive Action (CAPA).
• An example of product release experience—one of many: FDA-approved Mylotarg® ADC, a recombinant of humanized IgG4 kappa antibody conjugated with a cytotoxic antitumor antibiotic – calicheamicin. Preparation of Mylotarg® involves the bioprocess of fermentation of bacteria Micromonospora echinospora, subspecies calichensis.
• Extensive experience in research, development, and validation of analytical methods.
• Expert knowledge of HPLC, GC, GC/MS, TLC, UV-VIS, IR, and wet chemistry.
• Proven presentation and publication skills.
________________________________________
PROFESSIONAL EXPERIENCE
Aphranius Expert Group International Inc., Fair Lawn, NJ 2008 - Current

Aphranius is a small group of highly experienced scientists with more than twenty years experience in forensic science, organic and analytical chemistry, pharmaceutical science, toxicology, regulatory affairs and research and development. (www.aphranius.com)
Forensic Consultant to Corporate Chemical/Pharma Laboratories: Evaluate varied laboratories according to , but not limited to, following standards: ASCLD/LAB, CWA, EPA, ISO, DEQ, NELAP, NCA, DOH, CRMLN, CDC, AWWA/WEA, CMS/CLIA, DHHS, SAMHS*.
Evaluations include a laboratory's:
 Operating procedures, laboratory practices, certifications and personnel qualifications.
 Equipment and instruments used for analyses.
 Qualitative and quantitative analytical methods used, data analysis/validation.
Expert Witness to Legal Processes: Provide expert testimony to legal organizations, their clients and general industry in legal processes involving a broad range of chemical and personal issues.

Pfizer, Inc. (formerly Wyeth), Pearl River, New York 1999 –2008

Release Specialist (2002-2008)
Major responsibility: Authorized release of finished product commercial and research pharmaceutical production after extensive review of batch documentation and laboratory analysis reports.
• Assured Good Manufacturing Practice (GMP) compliance for disposition of bulk, finished packages, raw materials and packaging components for commercial distribution.
• Performed Quality Module transactions using SAP software system, including placing QA holds on material.
• Prepared Certificates of Analysis
• Interacted with quality unit senior personnel and upper management.

Senior Development Chemist (1999-2002)
• Developed and validated analytical methods for raw materials, intermediates and finished products.
• Participated in special studies such as validation of instrumentation.
• Assisted with chemical assay transfer.
• Planned and executed long term workload scheduling.
• Maintained laboratory records under GMP guidelines
• Prepared validation protocols, validation reports and SOP’s.
• Selected, purchased and supervised installation of new analytical instruments such as Varian’s Inductively Coupled Plasma Spectrometer.
• Performed scientific presentations and provided recommendations based on results of analytical research.

Nycomed US Inc. (formerly Altana, Inc), Melville, NY 1998 – 1999
Senior Development Chemist.
Responsible for development and validation of analytical methods for topical solutions, creams and ointments.
• Participated in new products development and feasibility studies.
• Successfully conducted international search for breakthrough technologies and pharmaceutical products.
Performed research and engineering for following companies: 1982 - 1998

NYC Police Department, Forensic Investigations Division, New York, NY
Frutarom, North Bergen, NJ
Chromack Research Inc Bound Brook, NJ
Castrol North America, Piscataway, NJ,
Impala Platinum Ltd. - Refineries, Springs, South Africa
Industries Development Corporation, Haifa, Israel


Education:
• Ph.D. in Chemistry, 2004, St. Petersburg Academy for Chemistry and Pharmacology, St. Petersburg, Russia.
• MS in Chemistry, 1978, St. Petersburg Technological University
• B.S. in Chemical Engineering, 1980, Technion-Israel Institute of Technology, Haifa, Israel.


Skills:
• Possess extensive experience in Quality Assurance, GMP, GLP, Root Cause Analysis (RCA), and Corrective and Preventive Action (CAPA).
• An example of product release experience—one of many: FDA-approved Mylotarg® ADC, a recombinant of humanized IgG4 kappa antibody conjugated with a cytotoxic antitumor antibiotic – calicheamicin. Preparation of Mylotarg® involves the bioprocess of fermentation of bacteria Micromonospora echinospora, subspecies calichensis.
• Extensive experience in research, development, and validation of analytical methods.
• Expert knowledge of HPLC, GC, GC/MS, TLC, UV-VIS, IR, and wet chemistry.
• Proven presentation and publication skills.


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