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Associate Project Manager / Project Manager CMC

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POST DATE 9/16/2016
END DATE 10/23/2016

MedImmune, LLC Gaithersburg, MD

Gaithersburg, MD
AJE Ref #
Job Classification
Full Time
Job Type
Company Ref #
Entry Level (0 - 2 years)


em strong This position can be filled as either Associate Project Manager CMC or Project Manager CMC. /strong /em br br The em strong Associate Project Manager/Project Manager /strong /em Chemistry, Manufacturing, & Controls (CMC) works collaboratively with CMC Team Leaders and CMC Teams to ensure Biopharmaceutical Development (BPD) project goals and milestones are achieved by providing project management expertise to CMC Teams ensuring smooth and efficient operational implementation of CMC strategy, and enabling project delivery in line with time, financial and quality requirements. This role also leverages and applies operational management experience where appropriate to support alliances and collaborations and maintains, promotes and influences CMC project information systems and tools. The CMC Associate PM/PM may contribute on behalf of CMC Team Management to operational process development initiatives. p /p Strategic Direction br * Leads translation of strategy into project plans and deliverables, communicates plans to the team as well as BPD leadership and Key stake holders as appropriate br * Project assumptions relating to time, cost and quality br * Contributes actively to the creation of development options evaluating risk and benefit and ensuring BPD activities are not on the critical path for product development. p /p Governance br * Leads the CMC in preparing for BPD leadership reviews based on BPD guidance. br * With the CMC TL, drives the development of key CMC aspects of governance pre-reads and presentations pulling together CMC information in a cohesive story/presentation. Ensures the governance presentations have a professional look and feel. br * Ensures CMC team presentations are reviewed by BPD Sr. Management as appropriate. p /p Team Leadership br * Understands, communicates and drives CMC team to meet the deliverables & goals and challenges appropriately br * Brings lessons learned from other projects to effectively drive project strategy br * Facilitates communications involving team members and external partners. br * Recognizes team members' contributions and accomplishments. br * Partners with the BPD functions to elevate and raise concerns regarding adequacy of resources & prioritization. p /p Assessing and Managing Issues and Risks br * Monitors risks in real time to ensure team engagement and mitigation plans are activated as required. br * Works with team to refresh risks & mitigation as needed. br br Responsibilities include (but not limited to) the following: br *Ensure effective integration of science and project objectives. br * Manage BPD activities for specified projects at all development stages, interfacing with relevant functional groups, and with external suppliers as necessary, to plan and coordinate the timely execution of CMC activities and contingencies. br * Lead and facilitate CMC Team meetings and responsible for project logistics and documentation. br * Influence, develop, maintain, own and deploy all key project management tools. Ensure tools are used appropriately to enhance project delivery and information dissemination to the business. br * Ensure the production and maintenance of requisite project documentation to ensure delivery of the overall CMC Plan and milestones. br * Interface internally and externally as required in evaluation of clinical and nonclinical material demand and to provide appropriate planning, coordination and communication to enable supply of materials and information of the required quality standard.. br * Enable communications to align project activities with Product Development Team (PDT) strategy, including planning of any necessary changes to the CMC deliverables, and aiding activities to secure PDT and BPD Leadership team support. br * Represent CMC Team Management in cross functional initiatives of business impact, such as would benefit the design and establishment of organization processes. br * Collaborate with BPD functional representatives, harnessing creativity within cross-functional project teams to develop risk mitigation and contingency scenarios for projects. br * Anticipate operational issues at the project level, and, working within the cross project community, to influence solutions for similar issues in other projects br * Communicate effectively with BPD, project teams, and with all interfacing functions and relevant governance bodies as required. p /p