Skilled in FDA, EMEA, Japan and other International regulatory agencies. Excellent background in method development, training, validations of equipments and methods, IND filing. Experienced in developing and implementing regional and nationwide quality programs for GMP and GLP laboratories, standard operating procedure and quality systems.

COMPANY	POSITION HELD	DATES WORKED
(Confidential)	(Confidential)	2/2001 - Present

SCHOOL	MAJOR	YEAR	DEGREE
University of Pheonix	Management	2007	Master Degree

Highlights:

• Managed several teams including up to 19 direct reports. • Handled several in sections from regulatory agencies world-wide. • Standardize global procedures for sample handling, critical materials management and analytical methods. • Developed several direct reports to take leadership roles. Was able get 15 employees promoted and transferred at different sites. • Developed and Trouble Shooting of several analytical methods using technology like EIA, RIA, PCR and threshold DNA. • Validated several equipments as required by the federal code of regulations. • Developed training documents for EIA and general methods like Volume, Spectrophotometer, Bradford and appearance. • Developed and participated in several strategies like Preparing the Organization for Future, Managing Resources Effectively, Six Sigma project for improving sample turnaround times. • Recipient of Spot Stock Award. • Developed Quality Assurance program sample management area in the reference lab with the sample load of 11,000 per day. • Developed and implemented training program for employees, and clients. • Responsible for about 60 employees over two shifts. • Participated in CAP and CLIA inspections. • Developed and validated about 200 methods using EIA and RIA techniques. • Developed and process improvement of PCRs, Gel electrophoresis for 150 methods. • Centrally managed inventory, prepared kits and method transfers for about 500 different methods for infectious and auto-immune diseases. • Transferred and validated several methods on automatic robots. • Validated ACS180, Hitachi, etc. • Trained about 50 employees at different levels. • Wrote over 100 analytical methods. • Managed group of five people. • Managed design and construction of new laboratories and development of testing kits for several infectious diseases, PCR for HIV, HCV and TB for use in Asia. • Supervised and completed more than 40 test developments in less than one year. • Trained and transferred PCR to Specialty-Ranbaxy India.

Companies I like:

ProCaps Labs, Genetech, Baxter, Bayer

P&L responsibilities
Presentation
Ecommerce Strategy and digital marketing channels optimization - SEO, SEM, email, affiliates - for high-profile accounts.
Technology Solutions
Sales Support
Software Implementation
Requirements Analysis & Specification
Leadership

• Quality Assurance

Quality Control, Global Standards