Senior Specialist, Project Manager, Chemistry Manufacturing & Controls (CMC)

Job Description

Global Project and Alliance Management (GPAM) sits in the Research & Development Division at our company. 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 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 Senior Specialist 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 Senior Specialist, Project Manager, is a core member of Development and Commercialization Teams (DCTs), partnering with team leads to develop strategies and execute our Company's drug and vaccine development efforts to progress the Research & Development pipeline. The Senior Specialist is expected to provide project management leadership and drive cross-functional teams with sufficient influence and proficiency in project management to take on 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 development process for projects that are of moderate complexity and/or work effectively with other team members to ensure successful execution of higher complexity development team strategies and project plans, guiding teams to develop comprehensive strategies and ensure successful execution.

• Guide teams through the creation, approval, and execution of integrated project plans appropriate to the project's phase of development and complexity.

• Build and maintain project schedules and critical project information, using these tools to integrate activities across key functional areas, work with team leads to 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, with guidance from senior team members and team leads as needed, to proactively identify and remove obstacles to drive business results.

• Navigate process and organizational norms to enable teams to understand corporate governance and business requirements, thereby enabling informed decision-making.

• Prepare for and facilitate 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 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.

Required Education, Experience, and Skills:

• Bachelor’s degree required; concentration in a scientific or applied discipline preferred

• Minimum of three (3) 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.

• Demonstrated ability to work independently to effectively accomplish goals in a team setting.

• Demonstrated ability to serve as a resource for colleagues and program teams.

• Effective interpersonal skills and ability to work collaboratively across diverse teams and networks; able to foster cooperation in others.

• Highly organized and capable of working with attention to detail; Excellent problem-solving skills and ability to build alignment around complex situations.

• Strong communication skills, both oral and written. Knows when and how to speak up and appropriately raise issues to team and to management.

• Ability to succeed in a dynamic environment with flexibility to respond to changing priorities.

Preferred Experience and Skills:

• 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

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