Technical Coordinator Microbiology

4 days left

Charles River Laboratories, Inc.
Malvern, Pennsylvania, US
Apr 28, 2021
May 10, 2021
Biology, Finance
Employment Type
Full time
Salary Type
For 70 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we'll help you build a career that you can feel passionate about.
Job Summary

We are seeking a Technical Coordinator Microbiology for our Biologics Testing Solutions site located in Wayne, PA.

This position will perform deviation and nonconformance investigations, author and revise batch records and protocols, and

communicate support activities to supervisors and managers across departments. Assist with management of client requests

for scheduling and technical information; assist with client audits. Assure that client CAPAs are addressed in a timely manner.

The following are the responsibilities of the Technical Coordinator Microbiology position:

• Write and revise SOPs, Batch Records, and other technical documents.
• Lead (act as project manager for) teams investigating major and critical nonconformances and deviations, including gathering

information through structured root cause analysis. Draft and revise deviation reports as needed to assure that deviations

are addressed in a timely manner.
• Own and manage change controls associated with Microbiology laboratories and equipment. Participate in client/sponsor

relationships (e.g., technology transfer, conference calls and sharing of technical information).
• Report results of experiments, tests, and procedures. Assist with management of client requests for technical information;

assist with client audits. Assure that client CAPAs are addressed in a timely manner.

The following are the minimum requirements related to the Technical Coordinator Microbiology position:

Education: Bachelor's degree (B.A./B.S.) or equivalent in biology or related discipline.
Experience: Two to four years industry related experience in a biological laboratory. An equivalent combination of education

and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.

Certification/Licensure: None

Other: Knowledge of CGMPs or regulatory affairs pertaining to the pharmaceutical and biological industries is suggested,

but not required. Basic understanding of general laboratory techniques. Must be able to perform basic math functions.

Must possess excellent interpersonal skills to maintain communication across functional groups. Able to communicate effectively

in a small group or one on one setting. Basic Microsoft Office skills required.

About Biologics Testing Solutions
With more than 50 years of experience and proven regulatory expertise, the Charles River Biologics group can address challenging projects for biotechnology and pharmaceutical companies worldwide. Offering a variety of services such as contamination and impurity testing, protein characterization, bioassays, viral clearance studies and stability and lot release programs, we support clients throughout the biologic development cycle, from the establishment and characterization of cell banks through preclinical and clinical studies to marketed products. Whether clients need stand-alone services, a unique package of testing, or insourced support, our Biologics group can create a custom solution to suit their needs. Each year more than 20,000 biologic testing reports are sent each and over 200 licenses products are supported by our biologics testing solutions team.

About Charles River
Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients' clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market.

With over 17,000 employees within 90 facilities in 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client's unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world. And in 2019, revenue increased to $2.62 billion.

At Charles River, we are passionate about our role in improving the quality of people's lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly supported the development of ~85% of the drugs approved by the FDA in 2019.

Equal Employment Opportunity

Charles River Laboratories is an Equal Opportunity Employer - M/F/Disabled/Vet.

If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.

For more information, please visit

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