Technical Coordinator Molecular Biology
Req ID #: 193137
Wayne, PA, US, 19087
For 75 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, well help you build a career that you can feel passionate about.
IMPORTANT: In order to be considered for this position,a resume/CV must be uploaded and submitted during the application process. Please make sure work history and education are added correctly.
We are seeking a Technical Coordinator, Molecular Biology for our Biologics Testing Solutions site located inWayne, PA.
Perform deviation and nonconformance investigations, author and revise batch records and protocols, and communicate support activities to supervisor and manager 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.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Write and revise SOPs, Batch Records, and other technical documents.
- Lead (act as project manager for) teams investigating major and critical nonconformance 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 Molecular 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.
- Ensure sample receipt and processing documentation is available for others (e.g. PDF and/or provide upon request).
- Train technicians on basic laboratory procedures, gowning, and applicable cGMP procedures.
- Assist with management of client requests for technical information; assist with client audits.
- Assure that client CAPAs are addressed in a timely manner.
- Maintain the Molecular schedule and guide the resolution of scheduling conflicts, both intra-departmental and inter-departmental.
- Maintain a safe working environment by adhering to Company policies and procedures.
- Follow all SOPs and other official instructions as they relate to specific tasks.
- Perform all other related duties as assigned.
- Bachelors degree (B.S.) or equivalent in biology or related discipline.
- 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.
- Able to communicate effectively in a group setting.
- Basic Microsoft Office skills preferred.
IMPORTANT: A resume is required to be considered for this position.If you have not uploaded your resume in your candidate profile, please return to upload field and attach your resume/CV.
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 20,000 employees within 110 facilities in over 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our clients 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 peoples 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 86% of the drugs approved by the FDA in 2021.
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.