Excellent opportunity for a Technical Shift Lead to join a Biologics Leader in the West of Ireland. The role will be responsible for leading New Product Introductions for the biologics operations team. The ideal person will have a proven people management experience and GMP experience in a pharma or biopharma environment.
Overview of your responsibilities (full job description available on request):
1. Serve as the primary contact and technical expert for the team.
2. Lead and support the team in activities such as compounding, filling, lyophilization, equipment preparation, formulation, buffer preparation, and processing to achieve operational goals.
3. Coach and mentor the manufacturing team to enhance effectiveness through clear communication.
4. Foster a culture of contamination control and adherence to aseptic best practices.
5. Communicate departmental goals to ensure the production of cost-effective, quality-compliant products safely and efficiently.
Knowledge, Skills and Experience Required for the Role:
6. At least 5 years of experience in batch processing, automation, commissioning, and validation in FDA/HPRA-regulated industries.
7. Bachelor's degree in chemistry, pharmacy, engineering, or a related field (advanced degree preferred).
8. In-depth knowledge of cGMP and pharmaceutical regulatory requirements.
9. Strong understanding of contamination control and aseptic processing standards.
10. Technical expertise in pharmaceuticals, biologics, or similar fields.
11. Preferably, at least 1 year of supervisory experience in a team setting.
12. Strong technical knowledge and application of industry practices, capable of solving complex problems with informed judgment.