Senior Manager, Quality Control, Sun Pharmaceutical Industries Inc.
Cranbury NJ.

• Managed the QC department with 20 people in the validation and cGMP testing groups to support R&D regulatory submission and commercial operations.
  
• Established the cGMP systems based on Corporate Quality guidelines to prepare the laboratory for the first FDA inspection.
  
• Established the equipment qualification master plan, upgraded the stability program to current industry standards
  

Manager, Stability, Sandoz (Novartis)
Dayton, NJ.

• Managed a group of 7 chemists and 3 sample coordinators /stability administration personnel for the Research and Commercial Stability Program. Responsibilities included stability storage and testing, sample flow, controlled drug substances and Reference Standards.
  
• Recognized for significantly improving the cGMP compliance of the stability program, the sample flow system to facilitate testing metrics reporting.
  
• Improved communication in the company by flow charting processes, obtaining buy-in from other functional groups to improve sample flow from manufacturing into the lab and information out to Regulatory.

Principal Scientist (Group Leader, Stability Management), Pfizer
St. Louis, MO.

• Managed a team of stability administrators and CMC documentation personnel for the Biologics Stability Program.
  
• Set up the cGMP systems required for the Commercial and R&D Biopharma Stability Program involving several contract facilities and Pfizer internal laboratories.
  
• Led a team of Engineers and Project Managers to construct and validate a state-of-the-art cGMP Stability Facility, completed on time and within budget.

Supervisor, Bioprocess QC, Monsanto Company
St. Louis, MO.

• Managed a team of 4 chemists in the General and Electrochemistry laboratories.
  
• Responsibilities included optimization and validation of analytical methods for the QC laboratory and release/stability testing of cGMP lots.
  

Scientist, Bioprocess QC, Monsanto Company
St. Louis, MO.

• Participated in the team to set up cGMP systems for the new Biologics QC laboratory. Responsible for the electrophoresis laboratory.
  
• Designed a composite worksheet system for recording raw data. Presented worksheet system at Industry meeting with positive response.
  
• Designed and implemented validated spreadsheets for performing calculations in the Bioprocess Analytical laboratory.
  

QA Methods Validation Specialist, Organics LaGrange
Northbrook, IL.

• Responsible for method validation and oversight of QC lab cGMP compliance.
  
• Optimized analytical methods for commercial QC lab.
  
• Served as company's technical contact with USP.
  
• Tripled the laboratory capacity by implementing chromatography system automation.
  
  • This project impacted virtually every group in the company, was completed on time, within allotted resources and performed error free after implementation.

Post Doctoral Biochemist, Northwestern University
Evanston IL.

• Interaction of proteins and peptides with liposomes and other lipid preparations. Protein and peptide conformation studies. Hands on experience in protein and peptide purification, synthetic organic chemistry, analytical techniques for amino acids, peptides and proteins, Circular dichroism, NMR, Fluorescence and other spectroscopic techniques.

Post Doctoral Biochemist, University of California at San Francisco
San Francisco, CA.

• Interaction of peptides with liposomes and other lipid preparations. Protein and peptide conformation studies. Hands on experience in peptide synthesis and purification, analytical techniques for peptides, Circular dichroism, NMR, IR and other spectroscopic techniques.

• Obtained training in subjects such as Certified Quality Auditor, Audit Preparation, cGMP Compliance, Project Management and Negotiation skills.