Tom McGrath Appointed New Vice President of Quality at LSNE
Manchester, NH – Lyophilization Services of New England (LSNE), a New Hampshire based contract manufacturing organization is pleased to announce that Thomas McGrath has been named Vice President of Quality.
In his new role, Mr. McGrath will have direct oversight of Quality operations at all LSNE manufacturing sites to include both Quality Assurance and Quality Control. He will be responsible for driving overall quality within the organization to the highest levels in order to assure compliance with regulatory directives and most importantly patient safety.
Mr. McGrath will report to Shawn Cain, Chief Operating Officer at LSNE. “We are delighted to welcome Tom to the organization. His strong technical expertise as well as his track record of developing and improving Quality Systems will be instrumental to aiding our growth as an organization and as we expand our commercial and analytical capabilities. I have tremendous confidence in his ability to maintain and build upon LSNE’s compliance history with all regulatory bodies.” said Shawn Cain.
Commenting on his new position, Mr. McGrath said, “The current regulatory landscape has put a greater onus on CMO’s to develop a strong, scientific risk based, quality system. As technology and scientific knowledge develop and strengthen, so must the quality systems that govern how we work.” He added, “LSNE has developed a robust quality system that is set up to evolve with the changing regulatory expectation. I am excited to be part of this very talented team and to maintain the stellar inspection history that LSNE has so diligently achieved.”
Mr. McGrath’s 17 year career includes extensive experience in the pharmaceutical, biotech and medical device industries. In his most recent position, Mr. McGrath was the Senior Director, Quality for Aseptic Services at AMRI Burlington, Inc. In this role he oversaw all QA, QC and Validation activities at the site and was instrumental in their recent Regulatory success. Prior to AMRI, he has held positions of increasing responsibility with development and quality at Praecis Pharmaceuticals Inc., CombinatoRx Inc., and AMAG Pharmaceuticals, Inc.
Mr. McGrath received his B.A. degree in Chemistry from The College of the Holy Cross.
LSNE is a privately held company with six GMP facilities – four located in New Hampshire, one in Wisconsin and one located in León, Spain. LSNE has been providing contract lyophilization services to the pharmaceutical, biotechnology and medical device industries since 1997, specializing in a wide range of services including process cycle development, fill finish and lyophilization (for vials, pre-filled syringes and dropper bottles for ophthalmics), and analytical testing. Through the thoughtful integration of six processing facilities, qualified staffing, and an extensive manufacturing history, LSNE is strategically positioned to provide products and services for clinical through commercial supply for pharmaceuticals and medical devices to a multi-national market.