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
Manage complex Process Development and GMP Manufacturing projects and proactively manage workflow, technical details, and deliverables necessary to meet competing project timelines. Engage in cross-functional collaboration with sales, client services, scientists, operational managers, finance, and quality assurance colleagues to ensure accurate tracking and reporting of project timelines, scope, and budget; identify and implement change controls when needed. Deliver exceptional product quality and customer service through proactive and clear communication with both internal and external stakeholders.
• Act as a central conduit for project communications between clients and Charles River staff for moderately complex to highly complex CDMO projects
• Lead project meetings, calls, and status reports; drive agendas and create detailed meeting minutes for project meetings; publish and track deliverables and action items
• Manage project start-up and key tasks such as kick-off meetings, project scheduling, and document and material transfers; mentor project managers collaborating on a large program
• Develop and maintain project timelines across multiple projects with input from technical leads and site schedulers
• Responsible for project/program scope, timelines, and budgets; provide mentorship and training for PMs on these tasks for client projects
• Proactively collaborate with technical leads and site schedulers to resolve resource constraints and scheduling issues and to prioritize ongoing work to meet competing project deadlines
• Independently identify scope changes and lead submission of SOW revisions/amendments to client services team. Able to assist with scope and pricing review to ensure accuracy in contracts.
• 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.
• Champion the use of advanced project management software to allow timely and transparent communication of project status across internal and external stakeholders
• 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 project documents to clients; monitor and track these tasks when completed by non-PM teams or staff (i.e., QA, MSAT, Validations, etc.)
• Collaborate with laboratory, finance, and accounts payable departments to ensure accurate and timely client invoicing and verify project pricing and completion in Smartsheet/SAP
• Identify and lead resolution of discrepancies in client billing/invoicing and when needed request credit/debit memos to address billing errors
• Address most customer requests, inquiries, and complaints independently; proactively engages appropriate SME or management when needed.
• Develop PM tools and resources to improve project management processes at the site level
• Contribute to training for new/junior PM staff; may mentor less experienced APM/PM staff
• Ensure adherence to pertinent regulatory requirements and to departmental policies, GMP practices, and procedures [SOPs, safety procedures and biosafety protocols].
• Participate in site-level committees and initiatives (i.e., process improvements, harmonization, etc.).
• Perform all other related duties as assigned.
Job Qualifications
• Bachelor's degree (B.A./B.S.) or equivalent in project management, business, biological sciences, or related discipline.
• Experience: Minimum 6 years related experience. PMP or equivalent desired and experience in a CMO/CDMO 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).
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 worked on 80% of the drugs approved by the U.S. Food and Drug Administration (FDA) in the past five years.
We’re committed to providing benefits that elevate your quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility.
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.
It is unlawful in some states (including Massachusetts) to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
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.
