Company Overview

At LaunchWorks, our people are our greatest asset.

We are a winning team of innovative, experienced, and knowledgeable contract manufacturing experts with a track record of turning complex life science ideas into high-quality products on-time and on-budget. We are committed to accelerating life science product commercialization by optimizing every step of the manufacturing process in order to create high-quality products for our customers that reach the market and the people that need it, safely and quickly.

Our operational competency has enabled us to maintain trustworthy and transparent relationships with our customers.

Our Quality Policy

As a Contract Design, Development, and Manufacturing Organization, LaunchWorks drives advancements in Life Science tools available to scientists, doctors, and patients. Launchworks develops and manufactures products consistently, exactly, and reliably to client specifications while meeting applicable quality and regulatory requirements.

Launchworks utilizes our unique change control system to facilitate rapid and compliant product updates for our clients, lowering their barriers to enter the market. By emphasizing continuous improvement, LaunchWorks ensures the effectiveness of its quality management system and regulatory compliance to meet or to exceed the objectives of our clients.

Certifications

ISO 13485:2016

ISO-13485:2016 Certified

Being ISO-13485:2016 Certified allows our customers to gain confidence that we have been audited by a third party and that we follow all the applicable regulations under the scope of our ISO certification. To download our certificate please fill out the form by clicking below.

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ISO 13485:2016

FDA Registrations

FDA REGISTRATION NUMBER3012351224

LAUNCHWORKS MANUFACTURING LAB
123 Brimbal Ave
Beverly, MA 01915
UNITED STATES

ISO 13485:2016

cGMP Facility

LaunchWorks adheres to the Current Good Manufacturing Practice (cGMP) regulations enforced by the FDA. These regulations assure proper design, monitoring, and control of manufacturing processes at all of our facilities.

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Partnerships

The National Research Council of Canada (NRC)

National Research Council of Canada

The NRC is Canada’s largest federal research and development organization. The NRC partners with Canadian industry to take research impacts from the lab to the marketplace, where people can experience the benefits. This market-driven focus delivers innovation faster, enhances people’s lives and addresses some of the world’s most pressing problems.

EVIK Diagnostic Innovations

EVIK Diagnostic Innovations

Evik’s Single-Assay Beads are precise and durable spheres, each originating from a few microliters of liquid reagent mix. Evik helps assay developers solve the common challenge of assay reagent stability by incorporating reagents into stable lyophilized beads that are versatile for use in micro-fluidic cartridges.

EVIK Diagnostic Innovations

Mercury Logistics

Mercury is the official LaunchWorks logistics partner, specializing in time and temperature sensitive supply chain management. Mercury creates customized shipping solutions and will proactively track every package, offering this and other solutions so you can focus on your business.

Associations

BioNJ

BioNJ

As the largest life sciences association in New Jersey, BioNJ is a powerful network of 400 Member companies representing research-based life sciences companies and stakeholders. Because Patients Can’t Wait®, we are dedicated to propelling the rich innovation ecosystem in the New Jersey region to stimulate and support innovation, improve and save lives, and lower the hurdles of healthcare advancements for society.

MassBio

MassBio®

MassBio® is a not-for-profit organization founded in 1985 that represents and provides services and support for the world’s leading life sciences supercluster. MassBio is committed to advancing Massachusetts’ leadership in the life sciences to grow the industry, add value to the healthcare system and improve patient lives.

Microfluidics Consortium – Centre for Business Innovation

Microfluidics Consortium

This Consortium brings together stakeholders in Microfluidics from across Europe and the USA to learn about state-of-the-art, recent applications, market dynamics as well as to collaborate to address key issues which are constraining growth and scale-up.

Management Team

Jeff Kelly

Jeff Kelly

General Manager

Jeff is responsible for delivering solutions and services to the clients and markets of LaunchWorks under parent company, Integreon Global. Prior to LaunchWorks, Jeff was developing and delivering single use technologies at Pall Corporation for bulk drug product and drug substance operations. Additionally, Jeff has experience at Integrated Biosystems (now part of Sartorius) that includes the development of bulk freezing technologies and handling solutions for biologics. Jeff graduated from Worcester Polytechnic Institute with Honors in Chemical Engineering.

Matt Smart

Matt Smart

Site Director

Matt Smart is an experienced Director of Operations with a demonstrated history of working in the biotechnology industry. Skilled in Process Optimization, Quality Control, Life Sciences, GMP, and Cross-functional Team Leadership, Matt was previously the Associate Director of QC Chemistry at Boston Analytical. Matt is a graduate of Merrimack College with a BS focused in BioChemistry.

Kammie L. McHugh

Kammie L. McHugh

Quality Assurance Director

Kammie is a Quality Assurance professional with over a decade of proven experience in the biotechnology and medical device industry. Prior to joining LaunchWorks Kammie worked at BioHelix. She has a BS in Biology from Salem State College, and a Masters in Science in Regulatory Affairs from Northeastern.

Launch Your Career Today!

LaunchWorks is always looking to our improve our company with talented new employees. Ready to join the winning team? Click below to see our current openings.

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