Manager Testing

MARK KRASS

** ****** **** ********, **. *****. 973-***-****, *********@*********.***

Summary

Manager/Supervisor who is detail oriented, efficient and technically thorough with experience in pharmaceutical, specialty chemical and manufacturing environments. Responsible for all testing in the raw materials area-assigning and review of testing, which includes coordination of testing in sister facility in Irvine, CA. Currently responsible for testing of all R&D, commercial excipients and packaging components on site, Generic and Branded.

Experience

2015- Present Leading Pharma, QC Dept. Fairfield, NJ QC Manager

• Validation, Stability, Calibration, Assay, Dissolution, HPLC, GC.

• Supervise 8 Analysts.

• Instituted a reduced testing program saving >$40K

• Created a revised SOP program.

2010-2015 Par Pharmaceutical QC Dept. Spring Valley, NY Group Leader/Manager Raw Materials

• Brought vendor based testing in house, cost savings >$50K

• Assign work in LIMS, and Trackwise software systems.

• Scheduling of all Raw Materials testing in lab both Commercial and R&D.

• United States Pharmacopeia, National Formulary and Pharmacopeial Forum (USP/NF and PF) monograph updates.

• Material qualifications including second source qualifying.

• Scheduling/prioritization of overtime and weekend analyst testing.

• Instituted a cost reduction reduced testing schedule for all materials. 2005- 2010 Par Pharmaceutical, QC Dept. Spring Valley, NY Group Leader Raw Materials

• Currently supervise six analysts with crossover to other analysts in Raw Materials.

• Maintain laboratory monograph database including updating and creation of new monographs for testing.

• Testing of new potential active API drugs for PAR products: wet chemistry, viscosity, and particle size.

Par Pharmaceutical, QC Dept. Spring Valley, NY

Scientist III

• Perform and document USP/NF or other compendia testing of pharmaceutical actives and excipients using wet and instrumental techniques.

• Perform routine testing and documentation of samples on marketed pharmaceutical products using wet chemical/instrumentation in conformance with laboratory SOP.

Nepera Corporation, Analytical Dept., Harriman, NY. 2002-2005 Senior Analytical Chemist

• Responsible for day to day plant operations testing of bulk and finished pharmaceutical products in a CGMP/SOP environment.

• Assay and impurity testing by HPLC and GC.

• Instrumentation including but not limited to FTIR, Microscopy, UV-Vis.

• Responsibility of plant water quality, environmental testing, stability and FDA pharmaceutical skip-lot testing.

• Calibration and validation of all laboratory instrumentation.

• SOP and method development

• Support to both plant operations and engineering. Colorite Polymers Corporation (custom compounding for the medical industry), Ridgefield, NJ.

1999-2002 QA/QC Supervisor Manufacturing/Production.

• Supervision of six lab technicians, one chemist.

• Responsibility of the ISO 9001 program.

• Responsible for all bulk raw material and finished products testing. for both divisions of the company.

• Responsible for written certifications of approval.

• Developed MSDS and electronic certification program.

• Respond to technical service requests and customer complaints as needed.

• Calibration of equipment and lab instrumentation including maintenance. ISP Corporation, Analytical Dept., Wayne, NJ

1980-1999 Staff Chemist

• Supervision of the Microanalysis Group (SEM/EM/EDX, X-ray diffraction, Laser light scattering, microscopy, image analysis, porosimetry, and surface analysis).

• Performed extensive morphological and particle size characterization of ISP pharmaceutical excipient product line .

• Preparation of technical reports including development of corporate methods and processes.

• Developed a true before and after replication technique for product skin and hair care evaluation.

ISP Corporation, Analytical Dept., Wayne, NJ

Chemist/Technical Speicalist

• Responsible for alpine and standard sieving, as well as SEM.

• Supported both manufacturing and customers.

• Identified inorganic contaminants in polymers and finished products.

• Conducted instrumental and wet chemical analyses.

• Supported photo-resist applications and drug delivery systems.

• Evaluated obscurants for military applications

• Provided technical support to Advanced Technology and GAF Building Products Groups.

Education 1973-1977 Jersey City State College, Jersey City, NJ BS/Biology.

Additional Professional courses:

• Advanced course in (HPLC, GC TLC, cGMPs, Dissolution studies, Bulk and Solid dosage forms, FTIR and FDA regulations).

• Scanning Electron Microscopy and X Ray Microanalysis,Lehigh University.

• Particle size measurement. The Center for Professional Advancement.

• Trace Elemental and Surface Analysis. Evans East.

• Improving measurement systems in Manufacturing Processes Qualpro.

• Multivariable Testing Techniques for R&D Processes Qualpro.

• Focus on Data DuPont Management and Technology.

• Laser Diffraction Training Malvern Corporation.

• Practical HPLC Troubleshooting LC Resources.

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