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CMC Validation Project Manager

Company: TSR Consulting Services, Inc.
Location: New Brunswick
Posted on: June 22, 2020

Job Description:

TSR is a premier National U.S. Staffing company with over 50 years of staffing excellence. Our client, a leading pharmaceutical client company is hiring a CMC Validation Project Manager on a long term consulting basis. Work Location New BrunswickNJ Summary Will drive the development and execution of integrated CMC strategies via Chemistry Manufacturing Control Teams (CMC) to enable RD Development Team objectivesdeliverables The Senior CMC Project Manager is closely partnered with the CMC Leader to enable effective execution of CMC strategy and plans The scope of responsibilities of the CMC Project Manager fall into 4 general categories which flex across all drug modalities, disease areas and stages of development Manages 4-6 CMCs and drives execution of program strategy by fostering communication and integration of all functional area representatives on the CMC team Drives and manages all CMC meeting logistics including the creation of clear and concise meeting minutes that will be shared as appropriate to align all functional representatives of decisions and actions agreed upon by the team Facilitates cross-functional sub-team meetings, as appropriate Responsible for the development of a detailed CMC project plan that is aligned with the overall program strategy Tracks all project milestones and clearly communicates status of project through the use of established PSI tools Facilitate pertinent CMC scenario planning to address changing businessclinic needs Gather stakeholder input, evaluate, collate, manage and communicate implications and adjustments to the overall plan Leverages portfolio and program management tools to track program execution, milestones, risks, and long range planning to ensure appropriate communication to team members and management Required Skills Bachelor's degree in engineering or relevant scientific discipline Strong project management, business process management, and optimization skills Familiarity with end to end CMC drug development with an understanding of critical milestones and typical bottlenecks preferred Strong organizational skills, ability to multi-task and work in a dynamic, fast paced environment Demonstrated ability to accomplish results and meet deadlines and commitments Demonstrated analytical and logic skills with a focus on fact-based decision making Demonstrated proficiency in MS Project, PowerPoint, Excel and Word Demonstrated ability to build relationships, influence, negotiate, and drive organizational engagement Experience developing andor managing program management tools to forecast budgets, timelines and resources preferred

Keywords: TSR Consulting Services, Inc., New Brunswick , CMC Validation Project Manager, Executive , New Brunswick, New Jersey

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