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CMC Project Manager

Charles River Laboratories International Inc (CRL)

Rockville, MD, US, 2085

CMC Project Manager Req ID #:  142232 Location: 

Rockville, MD, US, 20850 Rockville, MD, US, 20852 Rockville, MD, US, 20850 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.

IMPORTANT:   In order to be considered for this position, a resume/CV must be uploaded and submitted during the application process.  Please make sure work history and education are added correctly.  Job Summary The Project Manager leads project execution after deal closure. Responsible for directing, leading, and motivating multi-disciplinary project teams 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, Project Management is the key interface between Business development and Operations organizations and the customer. The Project Manager is managing multiple projects, either within one technology, or within multiple technologies and oversees the complete life cycle of all the projects. 

 

Essential Responsibilities:

•    Direct project’s scope, timelines and 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 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 ensures 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 •    B.S. in Life Sciences or related field, or equivalent experience.

•    3 years of experience in biologics manufacturing, preferably in viral vector production.

•    PMP Certification desired.

•    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.

•    Record of accomplishment of successfully managed projects.

•    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, oral, and presentation skills.

•    Pragmatic, organized, and results-oriented and with ability to manage multiple priorities.

•    Excellent planning, organization 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.

 

IMPORTANT: A resume is required to be considered for this position. If you have not uploaded your resume in your candidate profile, please return to upload field and attach your resume/CV. 

Vaccine Mandate

Charles River is a U.S. Federal Contractor.  As a result, we must follow the Presidential Executive Order to mandate vaccinations, and ensure our employees are fully vaccinated against COVID-19 by December 8, 2021.  Our main priority is the wellbeing, health, and safety of our people. We will be requiring proof of vaccination from all employees. 

Anyone with requests for disability-related and/or religious exemptions should contact Talent Acquisition (crrecruitment_US@crl.com) so that information can be provided about the accommodation process at Charles River.

 

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 18,000 employees within 100 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 >80% of the drugs approved by the FDA for the past 3 years.

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.

  

Nearest Major Market: Washington DC

Job Segment: Project Manager, Biotech, Manager, Pharmaceutical, Technology, Science, Management, Research

Job posted: 2021-11-30

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