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- Full Time
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