For 75 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
Responsible for management of complex Process Development and Good Manufacturing Practices (GMP) Manufacturing projects spanning from initiation of technology transfer through commercial operations, enabling successful project execution throughout the project life cycle, and accountable for providing mentorship to junior project management professionals who maintain a portfolio of Process Development and GMP Manufacturing projects.
- Act as a central conduit for project communications between clients and Charles River staff for highly complex CDMO commercial programs. Coordinate project status updates, status reports and create or coordinate with Project Coordinators detailed meeting minutes; publish, and track, deliverables, and action items.
- Oversee project start-up and key tasks such as kick-off meetings, project scheduling, and document and material transfers; may indirectly manage other project managers collaborating on a large program or portfolio
- Manage project timelines and milestones across a portfolio of projects through collaboration with technical leads and site schedulers
- Collaborate with cross-functional representatives to track and disseminate ongoing project status, including additions and changes to the scope of work, for cost and billing purposes.
- Lead collaboration with operations/technical management to prioritize ongoing work to manage and meet competing program/portfolio deadlines
- Advise clients on project scope and lead SOW revision/amendment submissions to client services team; able to support contract reviews to ensure accuracy in scope and pricing.
- Collaborate with cross-functional representatives in sales, Client Services, scientists, operational managers, Finance, and Quality to monitor, track and disseminate complex project deliverables and overall project status, including additions and changes to the scope of work, for cost and billing purposes.
- Develop, implement and maintain project management tools that allows timely and open communication of project status to all stakeholders, such as Smartsheet and MS Teams.
- Responsible for on-time delivery of final reports and program documents to clients; monitor and track these tasks when completed by others (i.e. a cross-site PM, QA, or report writing colleague)
- Identify and lead Project Management process improvement initiatives. Partner with other departments and sites, as well as clients, and provide leadership to carry these projects to successful completion. Additionally, recommend and implement of Key Performance Indicators (KPIs) as appropriate.
Job Qualifications
- Education: Bachelor's degree (B.A./B.S.) or equivalent in project management, business, biological sciences, or related discipline.
- Experience: minimum 10 years related experience in project management in a laboratory or research environment. PMP or equivalent desired and experience in a CRO/CMO preferred.
- An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
- Ability to multi-task, excellent written and verbal communication skills, organizational skills, and attention to detail. Possess analytical thinking and problem-solving skills. Ability to prioritize and re-evaluate priorities as situations change. Working knowledge of computer software (MS Office, MS Teams, Excel, Smartsheet) and database experience preferred)
The pay range for this position is $115,000 - $125,000. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.
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 20,000 employees within 110 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 86% of the drugs approved by the FDA in 2021.
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, or 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.