Associate Director Operational Excellence

Associate Director Operational Excellence Req ID #:  168096 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  

We are seeking an Associate Director, Operational Excellence, for our Biologics Testing Solutions site located in Wayne, PA. 

You may be required to work a rotating shift schedule that may require weekend hours.

The Associate Director, Operational Excellence will define, drive, and implement operational excellence strategic planning and initiatives. The major focus will be identifying and delivering sustainable programs in partnership with key stakeholders that simplify and streamline processes, improve quality, remove waste, and reduce costs. In this role, goals and successes will be measured using metrics developed by the Associate Director, Operational Excellence to drive future initiatives and gauge performance. Along with owning and driving the OpEx roadmap, the individual will leverage standard frameworks like Lean/Six Sigma as foundations for developing processes and strategies that work for our business.

In addition, this role will provide coaching support for functional leaders on subjects related to Operational Excellence and Lean leadership across the organization. You will be responsible to build strong relationships with your stakeholders, becoming proficient with their mission, processes, and requirements. You will define and drive the operational needs of the leadership team and their oversight of processes, methodologies, and corrective actions. You will lead the leadership team to identify and prioritize opportunities for improvement using Operational Excellence principles and methodologies. Using robust change leadership skills, you will communicate across the organization to ensure key stakeholders are aware and supportive of changes and their benefits, at all levels of the organization and locations as required.

ESSENTIAL DUTIES AND RESPONSIBILITIES: Establish an Operational Excellence strategy that can be implemented across multiple sites in a phased approach to drive the continuous improvement mindset, optimize efficiencies and holistically manages the flow and timing of people and material processes at the sites. Identify, develop, optimize and track common procedures and processes across sites, including harmonization/alignment and simplification of Standard Operation Procedures. Serve as subject matter expert (SME) for the Biologics sites in the philosophy, methods, tools and techniques of Lean/Six Sigma to identify and drive process improvement projects, resulting in an increase in throughput and capabilities of the business. Represent NA Biologics with Global Biologics Testing Solutions to ensure visibility, support and compliance with prioritized efforts.

MINIMUM QUALIFICATIONS:  Bachelor's degree (B.A./B.S.) or equivalent in a scientific, Engineering, Business Analyst or related field.  7-10 years related experience, with a minimum of five years in an Operational Excellence project management role demonstrating successful delivery of complex projects An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above. Certification/Licensure:  Lean Six Sigma Green Belt, Black Belt preferred; PMI  Demonstrated leadership skills and knowledge of cGMPs or regulatory affairs pertaining to the pharmaceutical and biotechnology industries is required. Demonstrated skills in word processing, spreadsheet generation, Project Management solutions (i.e. Microsoft project, SmartSheets) and general database applications.

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.  Our main priority is the wellbeing, health, and safety of our people. We require 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 - all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

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

Job Segment: Manager, Biotech, Engineer, Lean Six Sigma, Pharmaceutical, Management, Science, Engineering