Sr. Specialist, Project Management - Chemistry Manufacturing & Controls (CMC) (Hybrid)

Merck; New Jersey; On-site; USD 120,000 - 160,000; Full time

Job summary

Merck is seeking a CMC Integrated Project Management Senior Specialist to join Global Project and Alliance Management. This role partners with development teams to drive strategy and execution across the drug and vaccine development continuum, from Line of Sight to Transfer to Supply stages.

The Senior Specialist provides leadership with minimal guidance, aligning cross-functional teams, managing schedules, risks, and governance while advancing development milestones and commercialization

Qualifications

• 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 planning and execution of drug/vaccine product registration and commercialization/life-cycle management; translate knowledge to others.

Responsibilities

• Manage end-to-end development processes for moderately complex projects and guide CIPM teams to execute project plans.
• Lead creation, approval, and execution of integrated project plans aligned to development phase and complexity.
• Create and maintain project schedules; identify risks and ensure clear communication with stakeholders.
• Leverage relationships to improve team dynamics and remove obstacles to drive results.
• Navigate corporate governance and requirements to enable informed decision-making.
• Prepare and facilitate key team meetings with thoughtful agendas and accountable follow-through.
• Participate in CIPM and GPAM initiatives to improve ways of working and cross-department collaboration.

Skills

Adaptability

Change Management

Clinical Development

Clinical Supplies Management

Clinical Supply Chain Management

Clinical Trial Management

CMC Development

Communication

Corporate Governance

Cross-Functional Leadership

Drug Development

GMP

Interpersonal Communication

Interpersonal Relationships

KPI

Overcome Obstacles

Portfolio Management

Project Management

Project Planning

Risk Management

Teamwork

Working Independently

Education

Bachelor's degree

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.

The CMC Integrated Project Management (CIPM) 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 R&D 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 Chemistry Manufacturing & Controls development continuum from Line of Sight to First in Human to Transfer to Supply stage-gates.

Primary Responsibilities:

• Manage the end-to-end development process for projects that are of moderate complexity and/or work effectively with other CIPM 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 CIPM team members and team leads as needed, to proactively identify and remove obstacles to drive business results.
• Navigate our Company's 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 CIPM and Global Project and Alliance Management 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

Required Skills:

• Adaptability
• Change Management
• Clinical Development
• Clinical Supplies Management
• Clinical Supply Chain Management
• Clinical Trial Management
• CMC Development
• Communication
• Corporate Governance
• Cross-Functional Leadership
• Drug Development
• Good Manufacturing Practices (GMP)
• Interpersonal Communication
• Interpersonal Relationships
• Key Performance Indicators (KPI)
• Overcome Obstacles
• Portfolio Management
• Project Management
• Project Planning
• Risk Management
• Teamwork
• Working Independently

Preferred Skills:

• Detail-Oriented

US and Puerto Rico Residents Only:

Our company is co