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
The Associate Project Manager CMC provides project management support to CMC team members in the execution of activities such as manufacturing and release of drug substance and drug product, manufacturing process improvements and validation, analytical method development, transfer and validation, and shipping studies, and serves as the primary liaison with clients on CMC activities for client projects.
Key Responsibilities and Duties:
Provide project management support to CMC team members including PD, MS&T, and GMP teams in the execution of activities such as manufacturing and release of drug substance and drug product, manufacturing process improvements and validation, analytical method development, transfer and validation, and shipping studies.
- Serve as the primary liaison between the company and clients on CMC activities for the client projects.
- Collect updates on all CMC activities in the MS Project file on a monthly basis to update % completion or new dates.
- Assist with scheduling, conducting, and drafting minutes for PD, MS&T, and GMP team on respective client projects to ensure regular, efficient team, and stakeholder communication.
- Facilitate robust communication within PD, MS&T, and GMP teams to ensure all functions are aware of the schedule, changes in strategy and impacts to risks and resources.
- Hold team members accountable for on-time completion of tasks or milestones.
- Perform critical path analysis and supports scenario planning for CMC deliverables.
- Provide project coordination and communication, including participation in technical calls and face-to-face meetings, development of agendas, creation of meeting minutes, tracking of action items, and scheduling of follow-up meetings.
- Assist in preparing presentations, updating corporate project plans, etc.
- Other responsibilities as needed
Job Qualifications
- B.S. in Engineering or Biological Sciences is preferred
- At least 1 year of experience in biologics manufacturing, preferably in viral vector production strongly preferred
- Previous project management experience in the biologics production is preferred but not required
- Proven experience organizing, planning, and executing large-scale projects from vision through implementation
- Experience using project management tools (project scheduling and resource management), such as MS Project
- Proven analytical, conceptual and problem-solving skills are required to evaluate business problems and apply knowledge to identify appropriate solutions
- Exceptional team building and stakeholder relationship management skills are required, with the ability to establish rapport, persuade and effectively negotiate with senior management, key stakeholders and functions
Compensation Data
The pay range for this position is $56,500 to $65,500. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, 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 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 is an equal opportunity employer and is committed to providing equal employment opportunities for all qualified applicants and employees without regard to race, color, sex (including sexual orientation, gender identity, and expression), religion, national origin, ancestry, age, mental or physical disability, family status, pregnancy, military or veteran status, or any other characteristic protected by federal, state, or local laws.
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.
