Technical Coordinator Manufacturing Services

Technical Coordinator Manufacturing Services Req ID #:  173619 Location: 

Malvern, PA, US, 19355 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. Basic Summary  

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

This individual will be responsible for performing deviation and nonconformance investigations, communicate support activities to supervisors and managers in the cell banking and manufacturing area and perform technical review of draft and executed documentation. Assist with management of client requests for scheduling and technical information; assist with client audits of the cell banking/manufacturing area. 

ESSENTIAL DUTIES AND RESPONSIBILITIES: Maintain the Cell Banking and Manufacturing schedule and guide the resolution of scheduling conflicts, both intra-departmental and inter-departmental. Communicate with the Business Development and Project Management groups to ensure client projects are scheduled appropriately and milestones and deliverables are clear. Write and revise SOPs, Client Batch Records, and other technical documents. Assist with management of client requests for technical information; assist with client audits of the cell banking/manufacturing area. Assure that client CAPAs are addressed in a timely manner.

MINIMUM QUALIFICATIONS: Bachelor’s Degree (B.A./B.S.) or equivalent in biology or related discipline. 2-4 years 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. Working knowledge of cGMPs or regulatory affairs pertaining to the pharmaceutical and biotechnology industries required. In-depth understanding of and experience with cell culture and laboratory techniques is preferred. 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.

Vaccine Mandate

Charles River is a U.S. Federal Contractor.  As a result, we must follow the Presidential Executive Order to mandate vaccinations, and ensure our employees are fully vaccinated against COVID-19.  Our main priority is the wellbeing, health, and safety of our people. We require proof of vaccination from all employees. 

Anyone with requests for disability-related and/or religious exemptions should contact Talent Acquisition (crrecruitment_US@crl.com) so that information can be provided about the accommodation process at Charles River.

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 18,000 employees within 100 facilities in over 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. 

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 >80% of the drugs approved by the FDA for the past 3 years.

Equal Employment Opportunity

Charles River Laboratories is an Equal Opportunity Employer - all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

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 crrecruitment_US@crl.com. 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 www.criver.com.

Nearest Major Market: Philadelphia

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