Steve Lempitski

*** ******** ***, *******, ** ***49

Cell: 508-***-****

Email: acgyec@r.postjobfree.com

Professional Profile

A proactive, multi-skilled, and technically competent professional with

over 25 years of career success in quality control, testing, R&D, technical

support, audits, training, and customer handling in various FDA and USDA

regulated companies. Exhibits extensive experience in sterile product

manufacturing; SOP writing and review, benchtop assays; cleanroom reagent

preparation; and calibration, validation, and repair of scientific

instruments. Possesses comprehensive knowledge of the instrumentation and

testing methods under ISO, GMP and Part 11 compliance regulations.

Demonstrates excellence in developing and executing validation protocols

for instrumentation and manufacturing methods. Acknowledged team leader,

trainer, and motivator with ability to conduct customer training and

support at both FDA and USP headquarters. Possesses excellent planning,

problem-solving, and decision-making skills and works effectively on own

initiative to thrive in highly pressurized and challenging working

environments.

Major Accomplishments

. Played a stellar role during an FDA audit and ran a release test in

front of 5 agents

. Streamlined a manufacturing process and saved thousands of dollars in

materials and a full shift of production personnel per lot

. Developed a test method on a consumer product for an FDA safety recall

investigation and trained FDA lab technicians and staff in the test

. Discovered a performance flaw in a final product, identified the cause,

and implemented a manufacturing change to rectify the same

. Generated new sales accounts by adapting research use product protocols

for use in customers' existing analytical instrumentation

. Conducted specialized training for the lab technicians at the USP

biologics lab for standards release

Core Competencies

Testing

. Sterility ? Microbiology ? Flow Imaging Microscopy ? Cell Culture ? HPLC

? GC ? FP ? Endotoxin ? PCR ? ELISA ? LC-MS ? Aseptic Technique ? ISO,

GMP, and Part 11 guidelines ? Diagnostic testing under CLIA and HIPAA

guidelines

Methods Development/Product Improvement

. ELISA Development ? Mammalian Cell Culture ? Endotoxin Extraction ?

Cleanroom Manufacturing Formulation ? Technology Transfer

Career Summary

Mar 2012-Date TRIDENT BIOSYSTEMS, KOWLOON, HK

Technical Specialist

. Playing a client interfacing role for resolving technical questions

. Developing and coordinating activities and programs necessary to meet

and maintain quality standards and reliability of products while

providing suggestions required for achieving the best quality product

. Providing training and guidance in the FDA regulated sterile environment

manufacturing methods

. Assessing the training needs and conducting customer training in

analytical bench testing

. Actively involved in developing testing methods and writing and

reviewing the SOPs

. Taking stringent quality measures including preparation and maintenance

of necessary documents and conducting audits to ensure compliance with

standards

. Reviewing and adjusting existing strategies for quality monitoring and

improvement

Apr 1999-Feb ASSOCIATES OF CAPE COD, FALMOUTH, MA

2012

Technical Specialist - Instrumentation

. Maintained and calibrated testing equipment including tube readers,

plate readers, MS, TOC, and HPLC

. Traveled to customer sites for instrument installation, validation,

calibration, and assay training

. Developed endotoxin testing methods for both in-house and customer use

and wrote software and instrument validation protocols

Product Development Specialist

. Designed and implemented protocols to demonstrate feasibility and

conceived new products and manufactured prototype lots

. Eliminated a product defect through a manufacturing change and

streamlined a manufacturing process saving $50,000 worth of materials

and a full shift of production personnel per lot

Quality Control Technician

. Inspected all the in-process material stage wise and performed release

testing on raw materials, in-process and final product with key emphasis

on improving quality and improvement opportunities

. Prepared and reviewed SOPs used for QC testing and conducted stability

testing of products including pH and moisture while training new

technicians in all testing methods and instrumentation software

. Performed pre-production feasibility testing to determine optimal

formulation of final product

Beacon Diagnostics General Supervisor

. Performed testing of the clinical samples for fungal infection under

CLIA and HIPAA guidelines and manufactured the test calibration

standards

. Conducted testing as the reference lab for an FDA clinical trial while

reviewing technicians' data for validity and signing off the patient

reports

Technical Services Representative

. Visited customer sites to characterize and validate the assay on complex

samples and consulted with customers to troubleshoot and resolve assay

problems

. Developed a testing method for an FDA product safety investigation and

trained FDA technicians and staff in the method

Manufacturing Technician

. Prepared SOPs for manufacture of endotoxin detection products, standard

preparation, and GMP and formulated the final product from raw materials

under aseptic conditions

. Trained the new technicians in sterile technique, formulation protocols,

and use of instrumentation

Jun 1998-Mar LAB SUPPORT, BURLINGTON, MA

1999

Quality Control Lab Temp

. Undertook analysis of pharmaceutical samples using GC and HPLC systems

and performed the complicated special tests to implementing the quality

agenda

. Handled calibration, maintenance and troubleshooting of lab equipment

including GC & HPLC systems

Jul 1991-Mar SOLVAY ANIMAL HEALTH, GRAFTON, WI

1998

R&D Supervisor

. Played a key role as the Group Leader for developing ELISA assays for

animal vaccines and conducting release testing on final product as per

USDA guidelines

. Performed PCR, sterility, microbiology, and mycoplasma testing and

maintained the cell lines for viral potency testing

Dec 1987-Mar CLINICAL ASSAYS-SUBSIDIARY OF BAXTER HEALTHCARE, CAMBRIDGE,

1991 MA

Technical Support Representative

Education and Qualifications

. Bachelor of Science in Biology, Boston College, Chestnut Hill, MA (1987)

PUBLICATIONS / REFERENCES ARE AVAILABLE ON REQUEST

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