Director Scientific Services

Director Scientific Services Req ID #:  69355 Location: 

Wayne, PA, US, 19087 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

Responsible for providing scientific leadership to the Pennsylvania (PA) Biologics Testing Solutions business and for contributing to the Global Biologics Strategy, including establishing various analytical methods to support the Cell & Gene Therapy testing portfolio and identifying opportunities for expansion of science and technology. Support the development and growth of scientific staff through coaching, mentoring, and education/ training. Develop and direct scientific initiatives, both internally and externally to Charles River, to grow the business specifically targeting the Cell and Gene Therapy market. ESSENTIAL DUTIES AND RESPONSIBILITIES Provide strategic and scientific oversight to PA Biologics Testing Solutions business and support global biologics strategy, which includes the Cell and Gene Therapy market in particular, as well as molecular biology, virology, analytical and process validation, manufacturing of cell banks, vaccines and other areas. Provide support to operations and sales staff in responding to client requests that require scientific and/or regulatory with a special focus on the Cell and Gene Therapy industry. Provide support to clients and operations staff in day-to-day operations to develop sound scientific and regulatory compliant solutions in the design, execution and evaluations of studies, including addressing deviations and unexpected results. Participate in and prepare responses to both internal and external technical and quality assurance audits as required. Participate in industry technical and trade groups to enhance the company's image as an industry leader, generate new business leads, and strengthen market intelligence, with special focus on the Cell and Gene Therapy industry. Keep abreast of and guide staff on relevant scientific and technical advances and regulatory changes with a focus on the Cell and Gene Therapy industry. Provide guidance to senior management on industry trends. Identify subject matters (both technical and service-driven) for potential publication, presentation, etc. that help showcase CRL's technical and scientific expertise and dedication to customer service. Assist the site director with regular staffing and budgetary matters, and with related special projects. Support the Site Director in the development of short-range and long-range operating objectives, organizational structure, staffing requirements and succession plans. Support continuous improvement of processes in all related operating units. Perform all other duties as assigned.

MINIMUM QUALIFICATIONS: PhD or equivalent in biochemistry, virology, molecular biology or related field. 10 or more years of experience in the biotechnology or pharmaceutical industry. Strong background in biopharmaceutical testing to include molecular biology, virology, microbiology, manufacturing of cell banks, vaccine and analytical biochemistry. Experience in a CGMP environment. An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above. Must possess excellent management and communication skills and have the ability to lead a multi-disciplinary department. Must have solid understanding of cGMP. Regular domestic and international travel 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

Nearest Major Market: Philadelphia

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