Project Manager IVB

Project Manager IVB Req ID #:  65983 Location: 

Wilmington, MA, US, 01887 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 We are seeking a Project Manager for ourBiologics Testing Solutionssite located Wilmington, MA.

The following are responsibilities related to the Project Manager:

• With respect to all tests performed in In Vivo Biosafety, the project manager assures that:

• Study or assay protocols, including any changes, are approved as provided by applicable regulatory requirements and that the protocols are followed.

• All experimental data, including observations of unanticipated responses of the test system, are accurately recorded and verified.

• Unforeseen circumstances that may affect the quality and integrity of the study are noted when they occur, and corrective action is taken and documented.

• Test systems, including reagents, live cells, equipment or other material are as specified in the protocol.

• All applicable manufacturing practice regulations are followed, as applicable.

• Perform technical review of study data and ensure that studies are conducted accurately, efficiently and in compliance with CGMP regulations.

• All raw data, documentation, protocols, specimens, and final reports are transferred for archiving during or at the close of the study.

• Provide technical guidance to laboratory personnel, mentor staff in areas such as protocol and data interpretation and project related problem resolution.

• Routinely interact with technical and Quality Assurance staff to ensure compliance to departmental SOP, protocols, and CGMP regulations.

• Coordinate interaction with other Charles River work groups as it pertains to study procedures. This may involve Charles River Professional staff or other Charles River facilities.

• Interact with clients regarding sample submission, scheduling, execution and reporting.

• Participate in the creation and revision of protocols and SOP associated with CGMP testing, including standard and customer specific protocols and ensures that IVB staff is appropriately trained on these documents, either by conducting said training, or coordinating training.

• Efficiently organize, prioritize and plan work schedule.

• Assist Management in strategic project planning.

• Perform all other related duties as assigned.

The following are minimum qualifications related to theProject Managerposition:

• Education: Bachelor’s degree (B.A. /B.S.) or equivalent in a technically related discipline.

• Experience: Fiveyears related technical experience.

• An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.

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: Boston

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