Project Manager - IVB
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
Serve as study director for GMP studies, responsible for technical review of data and report compilation. Provide project leadership and coordination, including oversight of staff members involved in assigned projects.
ESSENTIAL DUTIES AND
Responsibilities:
- 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.
- 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.
- 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.
MINIMUM QUALIFICATIONS
- Bachelor s degree (B.A. /B.S.) or equivalent in a technically related discipline.
- Five to seven years 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.
PHYSICAL DEMANDS:
- Regularly required to move about inside the laboratory, communicate and operate a computer.
- Frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds.
- Specific vision abilities required by this job include close vision, distance vision, color vision, depth perception, and the ability to adjust focus.
- While performing the duties of this job, the employee may be required to use personal protective equipment (PPE) including gloves, protective clothing and eye protection.
WORK ENVIRONMENT:
- Work in a busy research environment including:
- use of sharp objects
- working around mechanical parts,
- working with or near known or unknown toxic or caustic chemicals and/or biological hazards,
- exposure to fumes and airborne particles.
- Work with biological samples with risk of exposure to zoonotic disease, and biohazards.
- This position may require occasional domestic travel.
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 2019, 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.
For more information, please visit www.criver.com.
Estimated Salary: $20 to $28 per hour based on qualifications.
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