Project Leader

We have an exciting opening for a Project Leader to work in our client’s growing Biologics Division located in Ballina, Co. Mayo, Ireland.

Why you should apply:

• Be part of a global organization. With a presence in over 20 countries, our client is strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving unique challenges.
• Start with the knowledge that your work helps to improve the health and well-being of many across the globe.
• The role is generously compensated, and attracts a competitive base salary and highly attractive benefits package.

What you will be doing:

• Lead the establishment/transfer of multiple methods from client to our test labs across a number of different disciplines.
• Make sure all new methods are validated in accordance with ICH guidelines, where appropriate.
• Create study plans and execute studies in strict accordance with SOPs ensuring full GMP regulatory compliance.
• Collaborate with the Quality Department for the generation of audit responses, deviation reports and study reports.
• Leading laboratory investigations.
• Reporting project progress information to management.
• Providing technical training to scientific team, as required.
• Day to day liaison with clients regarding current and new projects.
• Involvement with regulatory and client audits.
• Generating new and update current standard operating procedures, where required.
• Creating risk assessments for drug products, substances and processes as required.
• Making sure that all new equipment is qualified and validated in accordance with GMP and corporate validation requirement standards and guidelines.

What you need to apply:

• PhD in a relevant science discipline
• A minimum of 3 years relevant experience in Scientific Research preferably within a GMP regulated environment (EMEA/FDA) within the medical device, pharmaceutical or CRO Industry.
• Knowledge of study design, assay development, optimization, ICH analytical validation and project management essential.
• Skill in analytical techniques, molecular biology techniques e.g., PCR and Q-PCR or cell culture techniques and virology desirable.
• Capability to project manage multiple studies.
• Statistical software experience
• Ability to work on own initiative and problem solve