Our client site in Westport is 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 schedule of days and nights.
In this position, you will ensure high-quality product delivery, regulatory compliance, and financial performance, including cost reductions, while fostering a high-performance team culture.
Key activities:
* Serve as the primary technical contact and expert for your team.
* Lead and support your team in activities such as compounding, filling, lyophilization, equipment preparation, formulation, buffer preparation, and processing within the biologics fill-finish facility to meet operational goals.
* Coach and mentor team members to maximize effectiveness through clear communication.
* Promote contamination control and aseptic best practices.
* Communicate departmental goals to ensure cost-effective, quality, compliant products produced safely and efficiently.
* Collaborate with program management, supply chain, technical operations, quality, and engineering to plan, schedule, and execute manufacturing activities for both commercial and NPI clinical projects.
* Resolve operational and project issues with team members, clients, and other stakeholders.
* Drive operational excellence and achieve key targets such as OEE.
* Act as a subject matter expert interfacing with QA, HPRA, FDA, and other health authorities, including internal audits.
Qualifications:
* Minimum of 5 years' experience in batch processing, automation, commissioning, or validation within an FDA/HPRA-regulated industry.
* Bachelor’s degree in chemistry, pharmacy, engineering, or a related scientific field; advanced degrees preferred.
* Strong knowledge of cGMP and pharmaceutical regulatory requirements.
* Understanding of contamination control and aseptic processing regulations.
* Technical background in pharmaceuticals, biologics, or similar industries.
* At least 1 year of supervisory experience in a team environment is preferred.
* Strong technical skills with the ability to analyze complex problems, exercise judgment, and advise on appropriate actions.
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