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Charles River Laboratories Associate CMC Project Manager in Billerica, Massachusetts

Associate CMC Project Manager

Req ID #: 154093

Location:

Rockville, MD, US, 20850 Lowell, MA, US, 01854 Horsham, PA, US, 19044 Houston, TX, US, 77047 Labelle, FL, US, 33935 Rockville, MD, US, 20850 Bothell, WA, US, 98021 Boston, MA, US, 02116 Waltham, MA, US, 02451-1420 Fort Pierce, FL, US, 34982 Rockville, MD, US, 20852 San Diego, CA, US, 92121 Memphis, TN, US, 38104 Evanston, IL, US, 60201 Cambridge, MA, US, 02139 Roanoke, IL, US, 61561 Roanoke, IL, US, 61561 S. San Francisco, CA, US, 94080 Washington, DC, US, 20016-8061 Billerica, MA, US, 01821 Chicago, IL, US, 60654 Irvine, CA, US, 92612 Worcester, MA, US, 01608 Mattawan, MI, US, 49071 US Northridge, CA, US, 91325 Baltimore, MD, US, 21224 Framingham, MA, US, 01701 Ashland, OH, US, 44805 Thousand Oaks, CA, US, 91320 Redwood City, CA, US, 94063 Cleveland, OH, US, 44128 Wilmington, MA, US, 01887 New Haven, CT, US, 06519-6052 Charleston, SC, US, 29407 Raleigh, NC, US, 27610 Shrewsbury, MA, US, 01545 Wayne, PA, US, 19087 Charlotte, NC, US, 28203 Hartford, CT, US, 06106 Reno, NV, US, 89511 Detroit, MI, US, 48201 Macon, FR, 71000 Newark, DE, US, 19711 Hollister, CA, US, 95023 Groton, CT, US, 06340

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 Associate CMC Project Manager 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 between Vigene and clients on CMC activities for client projects

Essential Responsibilities:

• 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.

Job Qualifications

• B.S. in Engineering or Biological Sciences is required.

• At least 1 year of experience in biologics manufacturing, preferably in viral vector production 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.

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.

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