END DATE October 16, 2016

Manager CMC Project Management

Regeneron Pharmaceuticals, Inc. - Rensselaer, NY

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Job Description

p Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron markets medicines for eye diseases, colorectal cancer, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including hypercholesterolemia, oncology, rheumatoid arthritis, allergic asthma, and atopic dermatitis. /p p Summary: Using strong CMC Project Management knowledge, the PM leads the CMC Project team and drives the assigned CMC Projects with moderate to advanced complexity to completion. Plans and manages CMC Project activities including the development and monitoring of budgets and timelines. Develops productive relationships with internal and external collaborators/partners. Ensures quality and timeliness of deliverables are met for the project. Initiates and leads the decision-making and risk-management process. /p p Essential Duties and Responsibilities include, but are not limited to, the following: br / * Leads cross functional teams and manages the deliverables in a matrix organization in order to plan and execute the development strategy for the assigned CMC Projects. Drives the CMC Project evolution through completion within timeline, quality and budgetary constraints. Provides support to supervisor in assessing resource needs to achieve project timelines and quality milestones. br / * Facilitates the development of the integrated CMC Project plans relevant to the team deliverables and ensures alignment across relevant functions and smooth transitions among pipeline stages. Supports annual goal setting sessions to develop CMC Project level milestones that contribute to the overall Program milestones and for monitoring progress against these goals. Facilitates contingency and risk mitigation planning. Oversees, where appropriate, the development of the integrated CMC Project budgets, forecasts and timelines and is accountable to monitor progress against the approved baselines. br / * Ensures effective, accurate and timely communication across functional areas and corporate partners within the CMC Project/Program, serving as a primary point of contact among functional areas for CMC Project-related issues. Communication responsibilities include but not limited to S&OP, weekly/monthly project updates as well as Project specific Program overview plans ("TMPs"). Works with the supervisor/Department Director to identify and resolve any team and individual performance issues. br / * Creates, maintains and executes CMC Project plans (key deliverables and dossier items), timelines, agendas, resourcing requirements, rolling summaries, base lining and other tools required to facilitate planning and coordination of deliverables for each assigned CMC Project. br / * Coordinates and leads communication between global functional areas and corporate partners where applicable. Coordinates activities for writing data summaries or presentations for joint collaboration meetings, etc. br / * Proactively identifies issues and provides general guidance to resolve CMC Project issues and develops solutions to meet productivity and quality milestones and objectives. br / * Develops tools and mechanisms for monitoring progress and problem solving with CMC Project and functional area managers. Defines and documents working / best practices that can be used across other CMC Projects with all relevant departments in order to ensure that product is efficiently supplied to all non-clinical, clinical, and commercial sites. br / * Regularly interacts with Sr. Management or executive levels on matters concerning several functional areas. Exercises judgment and exerts some influence on the overall objectives and long-range goals of the CMC Project. Represents the department in relevant internal/external committees. br / * Coordinate the CMC regulatory activities required for submission of license applications, INDs, and other regulatory documents to government agencies. br / * Lead special projects as assigned by supervisor/department management. /p