ADC Biologics Manufacturing Team Lead

• Lead and manage the operations team, ensuring adherence to safety, regulatory, and operational requirements.
• Foster a high-performance culture focused on customer service, quality, compliance, financial performance, and inclusion.
• Oversee and execute filling, lyophilization, equipment preparation, formulation, buffer preparation, and support processing activities.
• Prioritize safety and compliance in all activities, conducting regular safety Gembas and promoting a culture of zero safety incidents.
• Review daily work activities to identify and address high-risk activities.
• Ensure compliance with EHS standards, procedures, and policies.
• Promote a culture of contamination control and adherence to aseptic best practices.
• Effectively deploy and manage team members to meet production schedules.
• Provide daily reporting on the status of operations and support activities.
• Lead, motivate, and direct the manufacturing team to maximize effectiveness.
• Foster team engagement through regular one-on-ones, clear expectations, feedback, performance reviews, and action plans.
• Develop direct reports through training, challenging tasks, and performance reviews.
• Promote a culture of Right First Time execution, Behavioral Based Safety, Always Audit Ready, and Human Error Reduction.
• Drive operational excellence and achieve key operations targets, including OEE.
• Ensure compliance with safety, environmental, and quality-related SOPs.
• Collaborate with other Technical Shift Leaders for interdepartmental planning and execution.
• Schedule human and material resources to meet production schedules.
• Utilize management infrastructure tools, trackers, visual management, tier meetings, and Gemba walks.
• Ensure smooth shift handover and communication of performance metrics.
• Identify and supervise critical process steps during your shift.
• Achieve financial targets by improving overhead spend, material usage, and labor efficiency.
• Manage cycle time and identify improvement opportunities.
• Collaborate with program management, supply chain, technical operations, quality, and engineering for effective planning, scheduling, and execution.
• Provide technical guidance and approval for manufacturing batch records.
• Verify and update manufacturing control system transactions accurately and timely.
• Serve as the key technical contact for aseptic fill-finish activities.
• Support the documentation and investigation of NCRs.
• Interface with QA department for interactions with HPRA, FDA, and other health authorities.
• Lead cross-functional risk assessments and continuous improvement projects.
• Compile and analyze data to track process performance.
• Provide technical expertise for investigations, root cause analysis, CAPAs, process improvements, and change control reviews and approvals.
• Manage compliance issues that may arise during shifts and ensure adherence to regulatory requirements.

• Degree, Masters or PhD in Life Sciences, Process Engineering, Biopharmaceutical Engineering or Chemical Engineering discipline
• A minimum of 5 years experience in batch processing, automation, commissioning and validation in an FDA/HPRA regulated industry.
• Detailed knowledge of cGMP and regulatory requirements relating to the pharmaceutical industry is required for this role.
• Comprehensive understanding of the principles of contamination control and regulatory expectations for aseptic processing.
• Has a technical background in pharmaceutical, biologics, or similar industries
• Experience of start-ups and/or new product introductions to bio-pharmaceutical/pharmaceutical facilities (Biologics Preferred). Must be able to lead & project manage these activities.
• Demonstrated project management skills, including the ability to deliver projects on schedule, within budget, and meeting the predefined quality and safety requirements.
• A minimum of 1 year team direct supervisory experience in a team environment
• Possesses a strong technical knowledge and application of concepts, practices, and procedures.
• Works on problems of complex scope where analysis of situations or data involves multiple competing factors.
• Exercises judgment and advises management as to the appropriate actions. ·

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