Senior Project Manager - Manufacturing Support
Recruitment by AphexIreland10 hours ago
ContractProject Management
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Purpose
The Senior Project Manager - Manufacturing Support is responsible for a broad variety of project management activities that support both Direct Manufacturing and Manufacturing Support across vial and syringe drug-product (DP) and finished drug-product (FDP) operations.
The role will help plan, coordinate and deliver New Product Introductions (NPIs), deviation lifecycle development, operational and strategic projects (including capital, reliability and process-improvement / volume initiatives). Embedded in Manufacturing Support, the post will partner closely with Direct Manufacturing, Process & Aseptic Owners, Quality, Engineering, Validation, MES/, Technical Writing and other site and global stakeholders to establish safe, compliant and sustainable project management that maintain supply continuity.
Responsibilities
* Support both Direct Manufacturing and Manufacturing Support across vial and syringe drug-product (DP) and finished drug-product (FDP) operations.
* Project manage timelines associated with complex investigations (deviations, aseptic excursions, batch issues, equipment failures) owning timelines, meeting scheduling, communications and lifecycle visualisations / tracking.
* Maintain daily/weekly project momentum with clear project controls, ensuring on-site presence and hands-on leadership of cross-functional teams.
* Lead and facilitate project meetings and governance forums to accurately capture and nd track actions, timelines, deliverables, milestones and decision-points; clarify and document roles and responsibilities and ensure timely closure and verification of action owners' commitments.
* Provide timely escalation of project risks and issues and make decisions that enable progress within the contract timeline.
* Effectively communicate with everyone involved in the project
* Have a controlled scope in place, that is understood by all stakeholders maintained throughout completion of the project
* Maintains Actions/Risk and Decision logs
* Works with resource managers from across the organisation to effectively obtain and allocate resources to complete programs and projects on time
* Define and align project objectives with Direct Manufacturing customers and site leadership. Create and maintain comprehensive project plans that address quality, scope, cost, schedule, resources and manufacturing readiness.
* Project Manage medium to large technical projects (capital, reliability, NPI, lifecycle) from concept through design reviews, build, validation readiness and handover to operations.
Qualifications and Experience
* Technical Degree and/or Masters' or equivalent
* 5-8 years of experience (including min of 3yrs as Project Manager) in a Life Science / Pharmaceutical / Biotechnology Environment
* Preferred Experience: Portfolio Management, Portfolio Resource Management, Business Case Development
Preferred Qualifications:
* PMP or PRINCE2 certification.
* Experience with Lean Six Sigma methodologies.
* Knowledge of industry-specific regulations and standards.
Systems / Equipment:
* Smartsheet, MS Office, MS Project, MS PowerPoint and MS Visio,
* Trackwise Change Control & Document Management Systems
The Senior Project Manager - Manufacturing Support is responsible for a broad variety of project management activities that support both Direct Manufacturing and Manufacturing Support across vial and syringe drug-product (DP) and finished drug-product (FDP) operations.
The role will help plan, coordinate and deliver New Product Introductions (NPIs), deviation lifecycle development, operational and strategic projects (including capital, reliability and process-improvement / volume initiatives). Embedded in Manufacturing Support, the post will partner closely with Direct Manufacturing, Process & Aseptic Owners, Quality, Engineering, Validation, MES/, Technical Writing and other site and global stakeholders to establish safe, compliant and sustainable project management that maintain supply continuity.
Responsibilities
* Support both Direct Manufacturing and Manufacturing Support across vial and syringe drug-product (DP) and finished drug-product (FDP) operations.
* Project manage timelines associated with complex investigations (deviations, aseptic excursions, batch issues, equipment failures) owning timelines, meeting scheduling, communications and lifecycle visualisations / tracking.
* Maintain daily/weekly project momentum with clear project controls, ensuring on-site presence and hands-on leadership of cross-functional teams.
* Lead and facilitate project meetings and governance forums to accurately capture and nd track actions, timelines, deliverables, milestones and decision-points; clarify and document roles and responsibilities and ensure timely closure and verification of action owners' commitments.
* Provide timely escalation of project risks and issues and make decisions that enable progress within the contract timeline.
* Effectively communicate with everyone involved in the project
* Have a controlled scope in place, that is understood by all stakeholders maintained throughout completion of the project
* Maintains Actions/Risk and Decision logs
* Works with resource managers from across the organisation to effectively obtain and allocate resources to complete programs and projects on time
* Define and align project objectives with Direct Manufacturing customers and site leadership. Create and maintain comprehensive project plans that address quality, scope, cost, schedule, resources and manufacturing readiness.
* Project Manage medium to large technical projects (capital, reliability, NPI, lifecycle) from concept through design reviews, build, validation readiness and handover to operations.
Qualifications and Experience
* Technical Degree and/or Masters' or equivalent
* 5-8 years of experience (including min of 3yrs as Project Manager) in a Life Science / Pharmaceutical / Biotechnology Environment
* Preferred Experience: Portfolio Management, Portfolio Resource Management, Business Case Development
Preferred Qualifications:
* PMP or PRINCE2 certification.
* Experience with Lean Six Sigma methodologies.
* Knowledge of industry-specific regulations and standards.
Systems / Equipment:
* Smartsheet, MS Office, MS Project, MS PowerPoint and MS Visio,
* Trackwise Change Control & Document Management Systems
Key Skills
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