Supervisor Microbial Cell Banking

Supervisor Microbial Cell Banking Req ID #:  141451 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 Supervise laboratory personnel and all activities related to microbial cell bank and testing within the Manufacturing Services group in Malvern, PA.

ESSENTIAL DUTIES AND RESPONSIBILITIES: Supervise daily laboratory activities and laboratory scheduling. Perform laboratory activities necessary for microbial cell bank and testing including but not limited to, the reagent preparation and routine testing of client samples. Ensure a quality product and excellent service to our clients. Train technical personnel in general laboratory skllls; reinforce regulatory concepts (cGMP) and Microbial cell bank and testing specific laboratory techniques. Perform technical troubleshooting Develop assays that meet regulatory guidelines. Support the customer service department. Develop and validate new assay formats as well as re-validate existing assays. Revise documents to ensure the microbial cell bank and testing laboratory maintains its compliance status. Oversee daily operational activities and supervise a group of non-exempt employees. Ensure optimum group performance. Responsible for personnel management activities such  as:   scheduling,   personnel  actions (hiring, promotions, transfers, etc.), training and development, providing regular direction and feedback on performance, disciplinary actions  preparing and delivering annual performance and salary reviews. Recommend short-range operating objectives, organizational structure, staffing requirements and succession plans. May assist in development of departmental budget. As required, oversee maintenance of group training manual and training records. Support the policy of equal employment opportunity through affirmative action in personnel actions. Ensure adherence to pertinent regulatory requirements and to departmental policies, practices and procedures (SOPs, safety procedures and biosafety protocols). Ensure that departmental equipment is maintained in good working condition and that departmental area(s) are maintained in a clean and orderly condition. Perform other related duties as assigned. MINIMUM QUALIFICATIONS Bachelor's degree (B.S./B.A.) or equivalent in biology or related discipline. Two to four years related laboratory experience; or equivalent combination of education or experience. Demonstrated leadership skills required. Working knowledge of cGMPs or regulatory affairs pertaining to the pharmaceutical and biotechnology industries required.

PHYSICAL DEMANDS: Regularly operates a computer and other office productivity machinery, such as a calculator, copy machine, and computer printer. Must occasionally move about inside the office to access file cabinets, office machinery, etc. Regularly provides information to and receives information from/through various technologies, media, sources and contacts. Must be able to accurately exchange accurate information  in these situations. Specific vision abilities required by this job include close vision and the ability to adjust focus, Occasionally stand for approximately 4 to 6 hours (not routinely). Must be able to observe the proper formulations of various sterile preparations and solutions. Must be able to manipulate and remove objects from shelves one and one half to six and one half feet above the floor (with the aid of a step stool). Must be able to work in spaces as narrow as 2 feet. May have exposure to potential chemical, electrical, biological and waste-handling hazards. 

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 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.

Nearest Major Market: Philadelphia

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