Associate Director, Project Management - Chemistry Manufacturing & Controls (CMC) (HYBRID)
Pharma
Job description
Job Description Global Project and Alliance Management (GPAM) sits in the Research & Development Division at our company (known as our company's Research Laboratories). The Project Managers in GPAM are core members of development teams at our company, driving these cross-functional teams to deliver projects and products that improve human health and business. Under GPAM, the CMC Integrated Project Management (CIPM) organization was formed to enhance our Project & Portfolio management functions which support Development and Commercialization Teams (DCTs) responsible for building and executing CMC development plans. Under the guidance of the CIPM Director & Portfolio Lead, the core responsibility of this individual will be to lead project management efforts to support Chemistry Manufacturing & Controls (CMC) product development from First in Human to Transfer to Supply, driving line of sight across the development lifecycle and maintaining programs in harmony with the portfolio. In addition, the Associate Director will be expected to participate in development of tools and processes to support holistic portfolio management and increased integration of CMC and Clinical strategies. Position Description/Summary: The CIPM Associate Director, Project Manager, is a core member of DCTs, partnering with team leads to develop strategies and execute our Company's drug and vaccine development efforts to progress the R&D pipeline. The Associate Director is expected to provide project management leadership and drive cross-functional teams with sufficient influence and proficiency in project management to take on challenging assignments with minimal guidance. Projects could span the full CMC development continuum from Line of Sight to First in Human to Transfer to Supply stage-gates. This position may be based in either Rahway, NJ or Upper Gwynedd, PA. Primary Responsibilities: Manage the end-to-end CMC development process, including projects of significant complexity; drive cross-functional teams and lead by influence to develop comprehensive strategies and ensure successful execution. Act as an enterprise leader by guiding teams through the creation, approval, and execution of integrated project plans appropriate to the project's phase of development and complexity. Drive development of a CMC strategy that is optimized for the portfolio. Build and maintain project schedules and critical project information, using these tools to integrate activities across key functional areas, proactively identify risks, and ensure clear and effective communication with key team, management, and cross-departmental stakeholders. Leverage relationships and networks to improve and enhance team dynamics, proactively identifying and removing obstacles to drive business results. Navigate our company process and organizational norms to enable teams to understand corporate governance and business requirements, thereby enabling informed decision-making. Lead key team meetings including creating thoughtful agendas, ensuring appropriate participation, contributing project management insights, and following up to ensure the team continues to make progress while holding others accountable. Participate in CIPM and GPAM departmental initiatives and workstreams aimed at improving the way that we work and the way that we interact with one another as well as other departments. Provide mentoring, coaching, and oversight to Specialist and Senior Specialist project managers working on common projects, sharing lessons learned and best practices to positively impact the community. Support multiple projects providing team management, stakeholder management, and governance preparation support to DCT teams. Required Education, Experience, and Skills: Bachelor’s degree required; concentration in a scientific or applied discipline preferred Minimum of five (5) years of experience in project management or a related role required Experience with the planning and execution of strategies for drug / vaccine product registration and commercialization / life-cycle management (can be R&D, manufacturing, or commercial perspective), with demonstrated ability to translate knowledge and expertise to other development teams and areas. Strong communication skills, both oral and written. Knows when and how to speak up and appropriately raise issues to team and to management. Keeps both team members, departmental colleagues (as appropriate), and management fully apprised of project initiative status and issues at the right level of detail Demonstrated ability to serve as a resource for colleagues and program teams. Effective interpersonal skills and ability to work collaboratively across different teams and networks; able to foster cooperation in others, using the different perspectives of others to generate ideas. Ability to succeed in a dynamic environment with flexibility to respond to changing priorities Preferred Experience and Skills: Advanced scientific degree (e.g., MS, MBA, Ph.D., PharmD) preferred Experience and knowledge of clinical drug development strongly preferred; including the different phases of development and how the various functional areas contribute to a comprehensive strategy Project management certification (PMP) and/or formal coursework/training in project management strongly preferred #eligibleforERP GPAMjobs #VETJOBS Required Skills: Clinical Research, Cross-Functional Leadership, Cross-Functional Project Management, Overcome Obstacles, Project Facilitation, Project Leadership, Project Management, Project Management Leadership, Project Planning, Project Tracking, Risk Management, Stakeholder Engagement, Strategic Planning, Strategic Thinking Preferred Skills: CMC Development, CMC Strategy, Drug Development Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative act
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