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Location:
Dublin
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Sector:
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Job type:
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Salary:
Negotiable
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Contact:
Next Generation
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Contact email:
barry.omahony@nextgeneration.ie
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Job ref:
JOB-14244_1759303855
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Published:
3 days ago
My client is seeking a Project Manager - Analytical Strategy Planner to join their Analytical Strategy & Lifecycle (ASL) team. This role will be responsible for managing the book of work across the ASL function, including project planning, timeline management, and capacity modeling for associated projects.
The successful candidate will identify and respond to critical path barriers, maintain a risk registry with contingency plans, and prepare executive-level progress reports. This is a cross-functional and dynamic role where project assumptions and scenarios may change, requiring adaptability and strong communication skills at all organizational levels.
The scope of work will include planning projects related to the lifecycle of commercial products with responsibilities covering analytical methods, specifications, reference standards, and comparability approaches. The Project Manager will collaborate with other planners, subject matter experts, regulatory colleagues, and leadership teams.
Key Responsibilities:
Provide analytical project planning and management by maintaining timelines, tracking milestones, and ensuring analytical CMC deliverables are achieved on time.
Define and monitor progress on deliverables, maintaining timelines and budgets in alignment with program milestones.
Coordinate financial and resource forecasting based on current and future activities.
Facilitate and communicate project activities with all stakeholders.
Maintain and update operational risk registers, track action items, and provide regular updates.
Manage multiple complex cross-functional process improvements supporting commercialization projects.
Lead development of integrated timelines and book of work in collaboration with analytical product leads and leadership.
Serve as a member of analytical sub-teams to align ways of working across brands, ensuring functional deliverables meet quality standards.
Ensure adherence to project budgets and propose capital appropriation requests as needed.
Proactively identify risks and work with teams to develop contingency plans.
Prepare and deliver routine status reports and progress updates.
Plan governance team reviews at appropriate milestones.
Oversee day-to-day operational activities, including reporting dashboards, review meetings, quality metrics, and management of repository platforms.
Qualifications and Experience:
Strong knowledge and experience in project management, including planning, resource allocation, and risk management.
Excellent organizational, time management, and communication skills.
Strong analytical and problem-solving abilities.
High attention to detail and ability to manage multiple objectives simultaneously.
Proven people and project management skills.
Education and Requirements:
Bachelor's degree in science or related discipline with at least 4+ years of pharmaceutical industry experience.
Minimum 3 years of project planning or management experience within a GMP manufacturing environment.
Experience or understanding of analytical methods applied to biologics (e.g., iCIEF, HPLC, CE, Bioassay, ELISA, LC-MS).
Biologics regulatory experience is an advantage.
The Next Step for you:
Should this position be of interest to you please submit your CV to Barry O'Mahony from Next Generation Recruitment using the apply button.
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