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Executive Consultant: Quality & Regulatory - Pharma, Med Device & Biotech. Perm / Contract. (+353)1 474 4669
Our client site in Westport are hiring a Manufacturing Supervisor - Biologics for their NPI Biopharma operations team. In this role, you will have the opportunity to lead an established team, developing and guiding its members technically and professionally. This is a shift-based role, requiring 12-hour shifts on a rotating day/night schedule.
Your responsibilities include ensuring product quality, regulatory compliance, achieving financial targets, and fostering a high-performance team culture.
Key activities:
* Serve as your team's primary technical contact and expert.
* Lead and support manufacturing activities including compounding, filling, lyophilization, equipment prep, formulation, buffer prep, and processing in the biologics fill-finish facility to meet operational goals.
* Coach and mentor team members to enhance effectiveness through clear communication.
* Promote contamination control and aseptic best practices.
* Communicate departmental goals to deliver quality, cost-effective, compliant products safely and efficiently.
* Collaborate with cross-functional teams for planning, scheduling, and executing manufacturing processes, including NPI and clinical trials.
* Resolve operational and project issues proactively.
* Drive operational excellence and meet key performance indicators like OEE.
* Interface with QA, health authorities (HPRA, FDA), and internal audits as a subject matter expert.
Qualifications:
* At least 5 years of experience in batch processing, automation, commissioning, or validation within an FDA/HPRA-regulated industry.
* Bachelor’s degree in chemistry, pharmacy, engineering, or related scientific field; advanced degrees preferred.
* Strong knowledge of cGMP and pharmaceutical regulations.
* Understanding of contamination control and aseptic processing standards.
* Technical background in pharmaceuticals or biologics industries.
* Minimum 1 year of supervisory experience preferred.
* Strong technical skills, problem-solving ability, and judgment in complex situations.
Additional details:
* Seniority level: Associate
* Employment type: Full-time
* Job function: Manufacturing
* Industry: Pharmaceutical Manufacturing
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Location updates: Westport, Castlebar, and nearby areas.
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