Role Summary
The Project Manager - Technical Strategy & Operations will oversee the portfolio of deliverables for the cross-functional Strategy & Lifecycle team. This role drives project execution, timeline management, and capacity modeling across a diverse book of work.
The ideal candidate will proactively identify critical path dependencies, manage risk registers and mitigation strategies, and prepare progress updates for executive leadership. Operating in a fast-paced environment with evolving priorities, the Project Manager must navigate fluid project scenarios, adapt quickly to change, and manage communication effectively across all organizational levels. Scope includes planning initiatives for commercial product lifecycles, focusing on analytical methods, specifications, reference standards, and comparability strategies.
Key Responsibilities
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Portfolio & Project Execution: Develop and maintain integrated project plans, track major milestones, and ensure technical CMC deliverables meet targets across multiple product portfolios.
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Governance & Alignment: Partner with functional leads to align localized timelines with global project schedules. Prepare recommendations for governance team reviews at critical project gates.
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Resource & Budget Management: Forecast financial and FTE resource requirements based on current and planned project portfolios. Monitor project spend and draft capital appropriation requests as required.
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Risk & Issue Mitigation: Maintain operational risk registers, track action items to resolution, and collaborate with key stakeholders to establish proactive contingency plans.
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Cross-Functional Collaboration: Facilitate communications across cross-functional teams, including internal and external testing partners, regulatory teams, subject matter experts, and leadership.
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Process Improvement: Lead medium-to-complex operational efficiency projects in support of commercialization strategies, establishing standard ways of working across product lines.
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Operational Reporting: Oversee day-to-day operations, including routine dashboard reporting, portfolio review meetings, departmental quality metrics, and document repository management.
Required Qualifications & Experience
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Education: Bachelor's degree in a scientific or related technical discipline.
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Industry Experience: Minimum 4+ years within the biopharmaceutical or pharmaceutical industry, including 3+ years of dedicated project planning/management experience in a GMP manufacturing environment.
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Project Management Expertise: Demonstrated competency in project scheduling, resource allocation, risk mitigation, and budget tracking.
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Technical Familiarity: Practical understanding of analytical methodologies applied to biologics (e.g., HPLC, iCIEF, CE, Bioassays, ELISA, LC-MS).
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Communication & Organization: Strong critical thinking, problem-solving, and time-management skills, with a track record of communicating effectively with senior leadership and cross-functional teams.
Preferred Qualifications
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Prior exposure to biologics regulatory frameworks and submission strategy.
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PMP, PRINCE2, or equivalent project management certification.
