Small-Scale Cell Operations Leader - GMP & Compliance

AbbVie Inc.; Sligo; On-site; EUR 90,000 - 120,000; Full time

Job summary

AbbVie is seeking a Small Scale Cell Operations Leader in Ireland to head manufacturing activities in the SSC facility. The role delivers drug substance materials, assures safety, quality, and regulatory compliance, and guides the team through operational performance and continuous improvement initiatives.

You will work with API and Technical Operations, providing technical leadership, coaching, and strategic planning to ensure on-time, right-first-time execution in a regulated environment.

Qualifications

• A degree or higher qualification in chemical engineering or a related discipline.
• At least three years' experience in batch processing operations within an FDA- or HPRA-regulated industry.
• At least three years’ relevant direct supervisory experience or training, including experience leading a team and participating in proactive improvement programmes.
• Proven planning and prioritisation skills, with the ability to organise team resources in line with changing business needs.
• Demonstrated problem-solving ability, attention to detail and a strong commitment to quality, compliance and right-first-time execution.
• Effective communication skills and the ability to work effectively across functions and stakeholders.
• Collaborative, results-focused leader with the resilience to drive issues to closure.

Responsibilities

• Lead the safe, compliant and on-schedule execution of pharmaceutical processing activities in the SSC facility and associated support areas.
• Provide clear direction, coaching and motivation to the manufacturing team, ensuring that priorities, tasks and performance expectations are understood.
• Plan people, materials and training requirements so that manufacturing activities can be delivered safely and efficiently.
• Work closely with shift leaders and cross-functional partners to plan and execute interdepartmental activities.
• Monitor, report and take ownership of departmental performance measures, including yield, rate, usage, attendance and overtime.
• Ensure manufacturing control system transactions and personnel records are completed accurately and on time.
• Maintain compliance with applicable safety, environmental, quality and cGMP procedures, and support the continued compliance of validated systems.
• Lead the development of team members through effective training, goal setting, growth planning, performance reviews and progressively challenging assignments.
• Support employee relations activities in partnership with Human Resources.
• Identify and implement improved work processes and contribute to continuous improvement programmes across SSC, API and the wider site.
• Represent and take ownership of the area during regulatory inspections and corporate audits.
• Collaborate with API Operations and Technical Operations to support new product introductions and new SSC manufacturing initiatives.
• Provide technical leadership and guidance to stakeholders, present relevant data and support timely operational decision-making.

Skills

Leadership

Batch processing

Quality compliance

Communication

Problem solving

Cross-functional

Education

Chemical engineering degree

Job description

AbbVie is seeking a Small Scale Cell Operations Leader in Ireland to head manufacturing activities in the SSC facility. The role delivers drug substance materials, assures safety, quality, and regulatory compliance, and guides the team through operational performance and continuous improvement initiatives.

You will work with API and Technical Operations, providing technical leadership, coaching, and strategic planning to ensure on-time, right-first-time execution in a regulated environment.