Advanced Biologic Product Specialist
2 weeks ago
We are seeking an Advanced Biologic Product Specialist to lead method lifecycle activities supporting advanced biologic products. In this role, you will ensure GMP compliance across sites in Ireland and the UK.
- Develop analytical methods for gene therapy programs.
- Manage analytical procedures, lab instrumentation, and material oversight.
- Maintain documentation according to regulatory and compliance standards.
- Oversee test method rollouts to meet project milestones.
- Ensure external testing activities comply with current GMP regulations.
- Provide training on newly introduced technologies and methodologies.
- Conduct routine assessments of analytical methods.
- Support the upkeep of the Quality Management System and uphold data integrity standards.
Key Skills and Qualifications:
- Background in health sciences or equivalent experience in a regulated industry.
- Experience in a validation role within a regulated environment.
- Ability to manage a team and deliver projects on time.
- Knowledge of EU and FDA regulations, GMP, and quality standards.
- Strong organizational skills with the ability to handle multiple projects simultaneously.
Benefits: We offer a challenging work environment with opportunities for growth and professional development.
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