Manager Methods Development

Manager Methods Development Req ID #:  79851 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 Manager, Methods Development, for our Biologics Testing Solutions site located in Malvern, PA.

This position will manage and direct the activities of a scientific group in the research and development of new assays, and in the transfer and execution of client/sponsor-directed assays. Develops strategies to ensure effective achievement of scientific objectives, monitors and evaluates completion of tasks and projects and may participate in budget development for capital expenditures and labor.

ESSENTIAL DUTIES AND RESPONSIBILITIES Manage the Methods Development group in the development of new assays focusing on the detection of adventitious agents in biopharmaceuticals as well as characterization of biological products. Activities include, but are not limited to: RNA and DNA isolation, DNA cloning, PCR/RT-PCR, virus infectivity assays, replication competent virus analysis, genome quantitation, gene therapy vector quantitation and characterization, cell potency analysis, copy number analysis, genetic stability analysis, and residual DNA analysis. Use of sequence analysis tools and DNA sequence databases to generate oligonucleotide primers and probes for PCR assay development. Monitoring the acquisition of study data and reviewing procedures and data. Ensure the transfer of new methods to appropriate departments for adequate qualification/validation studies for GMP compliance cEnsure on-time delivery of projects. Exercise independent judgement in developing methods, techniques and evaluation criteria for obtaining results. Act independently to determine methods and procedures on new assignments and supervise the activities of others.

MINIMUM QUALIFICATIONS: Bachelor's degree or equivalent in biology or a related discipline. Master's degree preferred. Minimum of 4-5 years related laboratory experience in Virology, Molecular Biology, Microbiology, Chemistry or related field. An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above. Demonstrated leadership skills required. Working knowledge of cGMPs or regulatory affairs pertaining to the pharmaceutical and biotechnology industries 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 2018, 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  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 .

Nearest Major Market: Philadelphia

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