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Site Director, Biologics

Charles River Laboratories International Inc (CRL)

Wayne, PA, US, 19087

Site Director, Biologics Req ID #:  66192 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. JOB SUMMARY

Charles River Laboratories is seeking a Site Director for the Biologics business located in Pennsylvania. Biologics provides tailored global testing and manufacturing services to support clients throughout the biologic development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized programs for companies that focus on vaccine, cell therapy and biosimilar development. ESSENTIAL DUTIES AND RESPONSIBILITIES As the Site Director, this individual will be a key member of the global Biologics leadership team with responsibility for providing leadership in the overall management and performance of the site, including execution of strategy, meeting of financial objectives and insuring that our employees are engaged and motivated to deliver the business objectives. Foster effective communication and identify problems in overall site operations. Develop and implement effective solutions for resolving operational issues Create an energizing work environment where our people can learn and develop, build a career and engage with their coworkers Maintain a respectful, diverse and inclusive environment that helps us attract, retain and engage our employees Work with other senior leaders to identify new business opportunities for internal or external development. Present site and overall CRL capabilities to potential new clients Manage site operations budget and maintain clear cost controls (including capital investments) to meet financial objectives Ensure that policies, practices, and procedures adhere to all applicable governing regulatory agencies and GMP guidelines Attain assigned and targeted performance of operational and site KPIs with focus on on-time reporting Provide business support structure for Global IT enhancements and developments Drive operational excellence through the application of new technologies and automation Contribute to the development of short and long range operational objectives, organizational structure, and workforce planning to meet the site’s long-term growth and financial objectives Participate and where appropriate, lead internal and/or external teams to select, implement and/or harmonize processes to maximize efficiency, market competitiveness and overall goals of Charles River Responsible for ensuring client expectations are met and issues involving study execution, quality or reporting are resolved in a way that maximizes client satisfaction Serve as the executive leader and liaison for site expansion projects. Represent the site to government, regulatory agencies, local, state and federal officials, industry groups, key customers and the general public as required

MINIMUM QUALIFICATIONS: Advanced degree (Master’s Degree, MBA, and/or Ph.D.) in scientific or business-related discipline Significant experience (8-10 years) in managing in a research or pharmaceutical environment, with demonstrated success in driving results Understanding of governmental regulations and guidelines. Knowledge of GMP regulations and other applicable FDA regulations. Excellent organizational skills and the ability to meet deadlines. Excellent communication (both written and verbal), leadership and negotiation skills. Ability to interact appropriately with all levels of employees, while at the same time support the efforts of departmental teams

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

Job Segment: Manager, Biotech, Scientist, Pharmaceutical, Management, Science, Research

Job posted: 2020-07-06

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