Excellent opportunity for a Manufacturing Shift Manager to join a leading Biologics company in the West of Ireland.
The role will be responsible for leading operations of a 24/7 biologics manufacturing team in a state-of-the-art bioprocessing facility.
Key Responsibilities:
* Serve as the primary technical contact for aseptic fill-finish activities, ensuring compliance with regulatory requirements.
* Supervise and execute compounding, filling, lyophilization, equipment prep, formulation, buffer prep, and support processing to meet operational goals, prioritizing efficiency and quality.
* Lead, coach, and mentor your manufacturing team on a 12-hour rotating shift, promoting clear communication of tasks and goals, and fostering a culture of collaboration and innovation.
* Promote a culture of contamination control and aseptic best practices on the floor, minimizing risk and ensuring product safety.
* Communicate departmental goals to produce cost-effective, quality-compliant products safely, aligning with company objectives.
* Collaborate with program management, supply chain, technical operations, quality, and engineering to ensure effective planning and execution of commercial and NPI clinical manufacturing, driving project success.
* Resolve operational and project issues by working with team members and stakeholders, utilizing strong problem-solving and conflict resolution skills.
Requirements:
* At least 3 years of experience in batch processing, automation, commissioning, and validation in FDA-regulated industries, demonstrating expertise in pharmaceutical production.
* Bachelor's degree in Science, Engineering, or a related field (advanced degree preferred), showcasing a strong educational background.
* Strong knowledge of cGMP and pharmaceutical regulatory requirements, staying up-to-date with industry developments.
* In-depth understanding of contamination control and aseptic processing standards, minimizing risk and ensuring product safety.
* Technical background in pharmaceuticals, biologics, or similar industries, highlighting relevant experience.
* At least 1 year of supervisory experience in a team setting, demonstrating leadership skills.