Senior Project Manager - Process Development

Role Overview

The Senior Project Manager for Process Development leads projects focused on new drug product introductions (NPI) and lifecycle management (LCM). This position reports to the Senior Manager of Process Development within the Portfolio Management & Delivery group and is responsible for directing cross-functional teams operating in a matrix structure to ensure successful project execution from start to finish. Strong collaboration with site subject matter experts, functional managers, and global partners is essential to drive product introductions, maintain product integrity, and accomplish projects safely, compliantly, and on schedule.

Primary Responsibilities

• Unite project teams, clients, and leadership on clear project objectives, deliverables, and criteria for success.
• Create and sustain comprehensive integrated project plans including quality, scope, schedule, cost, resource allocation, roles, and performance metrics.
• Oversee project governance structures and lead core team meetings to facilitate communication, decision making, follow-up actions, and accountability.
• Guide multi-disciplinary execution of NPIs and lifecycle initiatives for drug products and finished dosage forms.
• Translate project goals into actionable plans, ensuring progress aligns with milestones, budgets, and readiness benchmarks.
• Support effective coordination across site functions to enable smooth product launches and continued product health.
• Collaborate closely with site experts, management, and global functions to prioritize activities, resolve challenges, and secure necessary resources timely.
• Maintain transparent communication with stakeholders, actively managing risks, decisions, dependencies, and project status updates.
• Lead and influence diverse, international teams without direct hierarchical control to sustain project momentum amidst competing priorities.
• Manage project scope to ensure proper understanding and control through completion.
• Own risk and issue registers, driving mitigation and resolution efforts.
• Generate and oversee GMP change control documentation to support project activities.
• Ensure all project work complies with current Good Manufacturing Practices (cGMP), environmental health and safety, quality systems, and applicable business guidelines.
• Foster a culture of accountability and first-time quality execution within the project teams.

Required Skills and Knowledge

• Expert project and program management skills including planning, governance, risk oversight, stakeholder coordination, and progress tracking.
• Ability to work autonomously while effectively directing multinational and cross-functional teams within a matrix environment.
• Excellent influencing, communication, and conflict resolution capabilities to drive consensus and timely decisions.
• Skill in converting objectives into clear, measurable project execution plans.
• Strong aptitude to identify project gaps, assess risks, and address resource limitations through practical solutions.
• Commitment to continuous improvement using structured project management and problem-solving methods.

Qualifications and Experience

• Bachelor's degree in a relevant technical field is mandatory; a Master’s degree or equivalent experience is advantageous.
• 5 to 8 years of professional experience in life sciences, pharmaceuticals, or biotechnology sectors, with at least 3 years in project management roles.
• Proven track record of leading cross-functional projects in manufacturing or technical operations settings.
• Experience in new product introductions, lifecycle or portfolio management, resource planning, and business case preparation is preferred.

Tools and Systems

• Familiarity with Smartsheet, Microsoft Office Suite (including MS Project, PowerPoint, and Visio).
• Preferred experience with TrackWise for change control and document management.