Senior Project Manager CMC

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 Senior CMC Project Manager leads project execution after deal closure. Responsible for directing, leading, and motivating multi-disciplinary project teams, project managers, and hold team members accountable to deliver results within an agreed project governance structure to ensure customer satisfaction throughout the life of the projects.

Holistically plans all projects at any stage through mapping resource across projects.

In this role, the Senior CMC Project Manager is the key interface between Business Development and Operations organizations and the customer.

The Senior CMC Project Manager manages multiple projects, either within one technology or within multiple technologies, and oversees the complete life cycle of all the projects while managing a team of project managers.

Key Responsibilities and Duties :

• Direct project manager and project's scope, timelines, budget, and Project profitability
• Raise and prepare scope changes and communicate them to a customer in close collaboration with Business Development
• In collaboration with Business Development, create mid-long-term Project strategies
• Define, organize and be responsible for all customer communication (using an open communication model), agreeing on milestones and conducting "lessons learned" with the customer, as well as executing decommissioning at the end of contractual activities
• Ensure the right and effective internal and external governance are in place and are effective. Also ensure very clear alignment of internal stakeholders
• Responsible to ensure flawless and smooth execution of assigned contracted Projects according to defined timelines and cost, via leading multidisciplinary project teams
• During execution, key focus is on the customer centricity and internally on quality, cost, profitability, timelines, and risk management
• Manage Project budgets and material cost
• Additional duties as requested

Job Qualifications

• Bachelor's degree (B.A. / B.S.) or equivalent in project management, business, biological sciences, or related discipline with Life Sciences technical background, or equivalent experience. Master's Degree preferred
• Minimum of 5 years of experience in project management
• Experience in biologics manufacturing, preferably in viral vector production
• PMP Certification and experience in a CRO / CMO are preferred
• Previous technical competency in the areas of the Biologics Industry e.g., process development, cGMP manufacturing, process registration, analytical science, Quality Assurance etc.
• Strategic, operational, and technical project management experience
• Proven business awareness and commercial acumen
• Record of accomplishment of successfully managed projects and personnel
• Leadership and motivational skills to maintain naturally high moral within the Project management team
• Ability to communicate effectively at all levels across the organization. Has strength of character to have difficult conversations with senior stakeholders including customers, internal team members and senior management;

excellent written, verbal, and presentation skills

• Pragmatic, organized, and results-oriented and with ability to manage multiple priorities
• Excellent planning, organizational, and controlling skills
• Problem solving skills - ability to analyze using critical thinking and solve complex issues that do not have routine solutions
• Skilled with Microsoft Project, Teams, and other automated presentations

Compensation Data

The pay range for this position is $100,000 - $140,000 per year. 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.