Clinical GMP Program Manager

Company: Charles River Laboratories
Location: Billerica
Posted on: November 19, 2022

Job Description:

Clinical GMP Program Manager Req ID #: 207353 Location: Northridge, CA, US, 91325 Boston, MA, US, 02116 Evanston, IL, US, 60201 Cambridge, MA, US, 02139 Durham, NC, US, 27703 Hartford, CT, US, 06106 Baltimore, MD, US, 21224 New Haven, CT, US, 06519-6052 Thousand Oaks, CA, US, 91320 Mattawan, MI, US, 49071 Groton, CT, US, 06340 Worcester, MA, US, 01608 Roanoke, IL, US, 61561 Memphis, TN, US, 38118 Billerica, MA, US, 01821 Waltham, MA, US, 02451-1420 Detroit, MI, US, 48201 Skokie, IL, US, 60077 San Diego, CA, US, 92121 S. San Francisco, CA, US, 94080 Rockville, MD, US, 20850 Fort Pierce, FL, US, 34982 Bothell, WA, US, 98021 St. Louis, MO, US, 63110 Memphis, TN, US, 38104 Chicago, IL, US, 60654 Raleigh, NC, US, 27610 Beacon Hill, NSW, AU, 2100 St. Petersburg, FL, US, 33701 Houston, TX, US, 77047 Houston, TX, US, 77005 Wilmington, MA, US, 01887 Rockville, MD, US, 20850 Memphis, TN, US, 38118 Irvine, CA, US, 92612 Washington, DC, US, 20016-8061 Lowell, MA, US, 01854 Spencerville, OH, US, 45887 Cleveland, OH, US, 44128 Shrewsbury, MA, US, 01545 Roanoke, IL, US, 61561 Reno, NV, US, 89511 Framingham, MA, US, 01701 New Haven, CT, US, 06510 Horsham, PA, US, 19044 Rockville, MD, US, 20852 Newark, DE, US, 19711 Tranent, GB, EH33 1EH Charleston, SC, US, 29407 US Wayne, PA, US, 19087 Hollister, CA, US, 95023 Ashland, OH, US, 44805 For over 40 years, Charles River Cell Solutions has worked to making a positive impact on the world by providing the highest quality cellular material and services to biotech and pharmaceutical companies and research organizations that are performing innovative research and developing novel cell-based therapies. We recognize that our success depends on the vision and passion of our employees; that is why we are devoted to making Cell Solutions a rewarding and valuable place to work. We believe in making a difference, and at Cell Solutions, you will make a difference every day. 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 SummaryThe Clinical GMP Program Manager is the primary program driver for daily business activities and coordination of efforts between all departments and assigned customer programs. You will be the point person for interfacing with many external parties and internal stakeholders to ensure optimal performance of the program as well as communicate program policies and/or issues at department meetings as needed. Other activity will be to contribute program information and recommendations to strategic plans and reviews; prepare and complete action plans; implement program internal and external customer-service standards; resolve problems; identify trends, work to implement corrective and preventative action plans as necessary. Essential Responsibilities:--- Manage projects as needed and as assigned, assumes responsibility for management of activities critical to the success of the projects. --- Takes a leadership role and obtains cooperation and support from applicable management and staff from different departments to accomplish completion of projects.--- Maintain documentation such as the SOW, schedule, and all details (including POs and invoicing).--- Create and maintain a project plan based on the SOW.--- Coordinate internal and external communication from liaison and donor recruitment for collection scheduling.--- Schedule meetings with the customer and the team to review the plan and any relevant changes as well as updates.--- Oversee the schedule for the collection(s) and track the production process through logistics in MBS and if any delay or anomaly contact the function owner to resolve.--- Communicate scheduling changes to the internal and customer stakeholders on a timely basis.--- Monitor customer satisfaction during a pre-defined interval (monthly, quarterly, bi-annually) and organize business reviews.--- Provide education and training to employees and others as needed.--- Participate in meetings that Commercial team sets up with potential clients.--- Work closely with Marketing team as a SME when needed.--- Assists in developing, implementing, and monitoring program goals and objectives in a manner consistent with cost effectiveness and outstanding customer service.Job Qualifications--- Bachelor's degree preferred. Will consider equivalent combination of related education and experience. --- Two or more years previous experience in customer service or similar position.--- Experience with current Good Laboratory Practices, and/or current Good Clinical Practices and/or current Good Manufacturing Practices a plus.--- Must have reliable transportation and valid driver's license.--- Must maintain current, in-force vehicle insurance and acceptable driving record.--- Excellent interpersonal skills to resolve internal and external issues.--- Proficient use of Microsoft Office products including Word, Excel, Outlook and PowerPoint. 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. About Charles River Cell Solutions Charles River Cell Solutions is a global leader and trusted brand in the customization of human-derived biological products and services for biomedical research, drug discovery, and cell and gene therapy development. Cell Solution's vertically integrated solutions support preclinical research, clinical studies from phases 1 to 3, and commercialization with high-quality RUO and GMP-compliant starting material and apheresis collections. In January 2020, HemaCare was acquired by Charles River Laboratories, an early-stage contract research organization (CRO). Combined with Charles River's integrated, early-stage portfolio of discovery, safety assessment, and manufacturing support services, the acquisition creates a unique, comprehensive solution for researchers and cell therapy developers and manufacturers worldwide to help accelerate their critical programs from basic research and proof-of-concept to regulatory approval and commercialization. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs and enhances their productivity and effectiveness to increase speed to market. We work closely with our clients throughout the clinical process to maximize success and drive positive clinical outcomes. Together, 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 and biotechnology companies, government agencies, and hospitals and academic institutions around the world. At Cell Solutions, we are passionate about our role in improving the quality of people's lives. We have proudly supported the development of 100% of the current commercially available FDA-approved immunocellular therapies. Our mission is to provide a best-in-class portfolio of high quality, customizable human cellular material and services to support drug discovery, scientific research, and cell therapy. This resonates from our employees and impacts our customers because we know that every day is an opportunity to advance discoveries and make a difference in someone's life. 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, 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.

Keywords: Charles River Laboratories, Billerica , Clinical GMP Program Manager, Executive , Billerica, Massachusetts