Project Manager

PE Global is recruiting for a Project Manager for a leading multinational biotech client based in Dublin. This is an initial 12-month contract, remote role.

The Specialist Contract Development & Manufacturing provides oversight of New Product Introductions (NPI), technical support to the manufacturing team, solves complex production problems, and implements improvements to enhance efficiency and quality. They liaise between different departments to ensure a smooth manufacturing process and compliance with quality standards. They provide information insight and data analysis, drive execution of transactional/tactical tasks to ensure Amgen Contract & Development Manufacturing (ACDM) work cell (hub) success.

In this dynamic role, you will provide a strategic dimension to Amgen's manufacturing network to improve operational competitiveness and ensure uninterrupted global supply of medicines to our patients.

Responsibilities:

• Project Management and Technology transfers: The role involves leading and managing new product introductions (NPI) and technology transfers to external (third party) manufacturing organisations. This includes coordinating cross-functional teams, ensuring adherence to business processes, and overseeing multiple complex projects. Responsibilities also cover project planning, budgeting, communication, and reporting, as well as driving continuous improvement initiatives to enhance quality, efficiency, and alignment with company priorities.
• Follow-up and track activities in a department-wide project from conception to implementation and close-out. Manage timeline and highlight risks of transfer team activities; coordinate risk management activities as part of transfer; provide escalation to the right level.
• Manufacturing operations: Ensure accuracy and completion of data entries and/or tasks for budget development, monitoring, and reporting; contract inputs and requirements, confidentiality disclosure agreement(s), scope of work agreement(s), request for pricing/information, supply agreement(s) etc.
• Own Deviations (Major/Minor). Maintain and monitor systems to ensure all deviations received are appropriately investigated and concluded per the company's quality standards and procedures. Optimise deviations management, corrective and preventive actions effectiveness to prevent reoccurring events.
• Own SICAR | CAPA | CAPA EV and more complex change control records.
• Site performance monitoring: Report contract site performance metrics to site lead; identify improvement opportunities for site performance; daily duties will include coordination, issuance, and review of meeting minutes, conclusions from analysis of data and metrics, continuous improvement and standardisation of performance tools used by the Work Centre Teams (WCT), oversight and reporting of procurement/payment of invoices, and active participation in WCT meetings with the contract site as well as internal site team.

Qualifications:

Preferred Requirements:

• Bachelors in Business Administration, Engineering or Science-related field
• 5+ years of experience in protein, API, DS, DP or packaging manufacturing environment
• 5+ years in roles requiring knowledge of cGMP principles, FDA and other regulatory guidelines, and validation principles
• 2+ years of project management experience leading multi-functional and/or multi-location team
• 1+ years of experience working with external parties and/or leading cross-functional teams for clinical and/or commercial products

Preferred Competencies:

• Demonstrated matrix management and influencing skills.
• Strong organisational and cross-functional project management skills.
• Strong technical background with understanding of pharmaceutical manufacturing, commercialisation, and cGMP knowledge / experience.
• Demonstrated negotiation skills, accountability to deliver results and meet deadlines while handling contending priorities
• Strong project management skills.
• Operational Excellence proficiency and ability to drive continuous improvement.
• Financial/budgeting knowledge and business acumen.
• Problem-solving and critical thinking and decision-making skills.
• Understanding of contractual requirements.
• Technical writing and multi-level communication skills.
• Demonstrated ability to lead effectively in collaborative/team environment.
• Demonstrated ability to take initiative, drive action, and work under minimum supervision.
• Proficiency in Microsoft Office especially Project, Excel, PowerPoint, Visio, and Smartsheet

Interested candidates should submit an updated CV.

Please click the link below to apply, or alternatively send an up to date CV to [email protected]

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***