Project Manager

Purpose

The Senior Project Manager, Process Development is responsible for leading new drug product introduction (NPI) and lifecycle management (LCM) projects. Reporting to the Sr. Manager, Process Development within the Portfolio Management & Delivery (PMD) group, this role leads cross‑functional teams in a matrix organization to deliver integrated project plans, maintain robust governance, and ensure successful execution from initiation through close‑out.

The role partners closely with site SMEs, functional managers, and global stakeholders to drive product introductions, sustain product health, and deliver projects safely, compliantly, and on schedule.

Key responsibilities

Project leadership and governance

• Establish alignment among project teams, customers, and management on project goals, scope, deliverables, and success criteria.
• Develop and maintain integrated project plans covering quality, scope, schedule, cost, resources, responsibilities, and performance tracking.
• Lead project governance forums and core team meetings, ensuring clear communication, decision‑making, follow‑up, and accountability.

NPI and lifecycle delivery

• Lead cross‑functional execution of new product introductions and lifecycle management initiatives for DP and FDP.
• Translate project objectives into measurable execution plans and drive delivery against agreed milestones, budgets, and readiness requirements.
• Support the smooth introduction of new products and the ongoing health of existing products through effective planning and coordination across site functions.

Stakeholder leadership and cross‑functional coordination

• Partner with site SMEs, managers, and global functions to align priorities, resolve issues, and secure resources needed to deliver programs and projects on time.
• Communicate effectively with all stakeholders, ensuring risks, decisions, dependencies, and status are transparent and actively managed.
• Influence and lead cross‑functional and multinational teams without direct authority, maintaining momentum across competing priorities.

Risk, change control, and execution management

• Maintain controlled project scope throughout execution, ensuring scope is understood by all stakeholders and managed through completion.
• Own project risk and issue management, including action, risk, and decision logs, and drive appropriate mitigation and remediation plans.
• Generate and own GMP change controls required to support project delivery.

Compliance and quality expectations

• Ensure all work is executed in alignment with cGMP, EHS, quality system requirements, and applicable business and financial guidance.
• Promote a culture of personal accountability, compliance, and right‑first‑time execution across the project team.

Skills and knowledge

• Strong project and program leadership capability across planning, governance, risk management, stakeholder alignment, and delivery tracking.
• Ability to work independently while leading across multiple stakeholders and multinational teams in a matrix environment.
• Strong influencing, communication, and conflict resolution skills, with the ability to affect change and drive decisions.
• Proven ability to translate goals and objectives into measurable execution plans.
• Strong capability to identify gaps, risks, and resource constraints and implement practical remediation plans.
• Continuous improvement mindset with effective use of project management and structured problem‑solving tools.

Qualifications & Experience

• Bachelor's degree in a technical discipline required; Master's degree or equivalent experience preferred.
• 5–8 years’ experience in a life sciences, pharmaceutical, or biotechnology environment, including a minimum of 3 years in project management.
• Demonstrated experience leading cross‑functional delivery within a manufacturing or technical operations environment.
• Experience supporting NPI, lifecycle management, portfolio management or resource planning, and business case development is preferred.

Systems & tools

• Working knowledge of Smartsheet, MS Office, MS Project, MS PowerPoint, and MS Visio.
• Experience with TrackWise change control and document management systems preferred.