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
With minimal supervision, perform daily laboratory tasks. Responsible for executing complex Microbiology testing and data interpretation following documented test methods and procedures according to cGMP. Perform and train others on Environmental Monitoring, Sterile Services and/or Mycoplasma Testing. Perform method development work as assigned.ESSENTIAL DUTIES AND RESPONSIBILITIES:
ESSENTIAL DUTIES AND RESPONSIBILTIES CON'T
- Perform laboratory activities necessary for Microbiology testing including, but not limited to, reagent and media preparation, growth promotion of media and reagents and the practice of aseptic technique working within a biological safety cabinet.
- Perform routine laboratory maintenance including, but not limited to, cleaning of equipment, stocking of the laboratory and disposing of laboratory waste.
- Complete gowning certification as necessary.
- Complete training on the performance of assays and/or Environmental Monitoring as assigned by their current Supervisor or Manager.
- Duties specific to Environmental Monitoring may include, but are not limited to:
- Oversee the general maintenance of all equipment related to the performance of Environmental Monitoring and schedule repairs as required. Perform any laboratory maintenance and/or monitoring as necessary.
- Responsible for the execution of both static and dynamic Environmental Monitoring, and updating the EM Database.
- Perform preparation of sample material and all environmental and personnel isolates recovered during Environmental Monitoring for microbial identification, and updating the Microbial Identification Database.
- Perform data quires and trending analysis as requested within the EM database and/or Microbial Identification Database.
- Generate routine queries as required for quarterly EM trending.
- Schedule and assign EM coverage for all manufacturing campaigns as well as routine static monitoring of the facility.
- Duties specific to Sterile Services may include, but are not limited to:
- Perform bioburden and bioburden verification testing via pour plate and/or membrane filtration methods.
- Perform bacteriostasis and fungistasis testing via direct inoculation and/or membrane filtration.
- Perform sterility testing via direct inoculation and/or membrane filtration.
- Perform mycobacterium testing.
- Perform bacteriophage testing.
- Perform microbial stock generation and the activities related to release of the stock.
- Schedule and assign routine testing to ensure turnaround times are met.
- Duties specific to Mycoplasma Testing may include, but are not limited to:
- Cultivable mycoplasma testing using broth and agar cultures following various compendia.
- Non-cultivable mycoplasma testing using indicator cell culture following various compendia.
- Perform mycoplasmastasis testing (inhibitory testing) following various compendia.
- Perform mycoplasma stock generation and the activities related to release of the stock.
- Schedule and assign routine testing to ensure turnaround times are met.
- Participate in the validation and qualification of Microbiological assays and/or equipment.
- Make detailed observations and maintain clear, accurate and timely documentation of all laboratory work.
- Inform the appropriate department and/or Client Account Manager of Environmental Monitoring excursions and/or concerns related to Sterile Services and/or Mycoplasma, as necessary.
- Cross train on procedures performed by other functional groups both inter and intra departmentally in order to serve as a secondary technician on assays not generally performed by the functional group in which they report.
- Review and edit SOPs, protocols and testing documentation.
- Participate in client/sponsor relationships (e.g. technology transfer, conference calls and sharing of technical information).
- Efficiently organize, prioritize and plan work schedule.
- Train both Technicians I and II on all Microbiology procedures and techniques as required.
- Perform other related duties as required.
- Bachelor's degree (B.S.) or equivalent in biology or related discipline.
- Minimum 2 years related industry experience, preferably in a pharmaceutical or contract laboratory environment.
- Able to demonstrate a strong technical understanding in Microbiological practices and apply them to perform complex assays.
- An understanding of Microbiological compendial guidelines as outlined in the United States Pharmacopoeia, the European Pharmacopoeia and the US FDA Points to consider references is a plus.
- A combination of education and experience may be accepted as a satisfactory substitute for education and experience.
- Computer proficiency in MS Word, Excel, Outlook, instrumentation and analysis software.
- Excellent verbal, written communication and organizational skills.
- Demonstrated independent analytical and problem solving abilities.
- Demonstrated knowledge of GMP regulations.
- Ability to maintain client/sponsor relationships.
- Ability to interact appropriately with all levels of employees.
- Ability to work effectively as a member of a team.
- Must be able to remain in a stationary position 50% of the time while performing laboratory tasks.
- Regularly operate a computer and other office productivity machinery, such as a calculator, copy machine, and computer printer.
- Regularly observe, inspect, and interpret laboratory experiments, requiring close vision and the ability to adjust focus and detect and differentiate colors.
- General laboratory working conditions.
- Work within a certified cleanroom environment (cleanroom suits).
- Regularly wear protective clothing (hair net, gloves, scrubs, lab coat and safety glasses).
- Regularly work with or near toxic or caustic chemicals.
- Frequently work with biohazards.
- While performing the duties of this job, the employee may work near moving mechanical parts.
- Regularly exposed to fumes or airborne particles.
- The noise level in the work environment is usually moderate.
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 by December 8, 2021. Our main priority is the wellbeing, health, and safety of our people. We will be requiring 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 - 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 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.