Excellent opportunity for a Manufacturing Shift Manager to lead the operations of a 24/7 biologics manufacturing team in our state-of-the-art bioprocessing facility.
Job Description
* Serve as the primary technical contact for aseptic fill-finish activities, ensuring seamless execution and compliance with regulatory requirements.
* Supervise and execute compounding, filling, lyophilization, equipment prep, formulation, buffer prep, and support processing to meet operational goals and deliver high-quality products safely.
* Lead, coach, and mentor your manufacturing team on a 12-hour rotating shift, fostering a culture of open communication, clear expectations, and shared accountability.
* Promote a culture of contamination control and aseptic best practices on the floor, minimizing risks and maximizing efficiency.
* Communicate departmental goals to produce cost-effective, quality-compliant products safely, aligning with company objectives and industry standards.
* Collaborate with program management, supply chain, technical operations, quality, and engineering to ensure effective planning and execution of commercial and NPI clinical manufacturing.
* Resolve operational and project issues by working with team members and stakeholders, applying problem-solving skills and creative thinking.
Requirements
* At least 3 years of experience in batch processing, automation, commissioning, and validation in FDA/HPRA-regulated industries, with a strong understanding of cGMP and pharmaceutical regulatory requirements.
* Bachelor's degree in Science, Engineering, or a related field (advanced degree preferred), with a technical background in pharmaceuticals, biologics, or similar industries.
* In-depth knowledge of contamination control and aseptic processing standards, with at least 1 year of supervisory experience in a team setting.