LYO Project Manager

Summary:

A global biopharmaceutical company based in Waterford is seeking a LYO Project Manager who will be responsible for overseeing a drug product filling project, a change of drug substance supply to site, and a drug substance generation project. This role is site-based.

Responsibilities:

• Lead cross-functional, multi-site teams, in the introduction and business integration of projects.
• Translate customer needs into defined, approved project scope statements.
• Work with functional managers to quantify resource requirements.
• Establish detailed project plans and drive execution of project tasks in line with agreed scope, schedule, and cost.
• Establish and execute a communication plan for the project and facilitate information flow between stakeholders and sites.
• Drive project risk identification, analysis, response, and implement & monitor mitigations to minimise impact to the project or wider business.
• Facilitate cost estimation to determine project budget and drive adherence to budget and forecast submission.
• Project Stakeholder Management to analyse stakeholder expectations and their impact on the project, and to develop appropriate management strategies for effectively engaging stakeholders in project decisions and execution.
• Responsible for some project GMP documents in line with the site procedures; therefore, training to Waterford GMP systems is required.

Qualifications & Experience:

• Degree in Science, Engineering or equivalent.
• 5 years’ experience in biopharma industry, in a project leadership role.
• Demonstrated experience in project/program management in drug substance or drug product.
• Project Management certification, PMI.
• Working knowledge of cGMPs and GLP.