Small-Scale Cell Operations Lead for GMP Manufacturing

AbbVie; Sligo; Vor Ort; EUR 90.000 - 120.000; Vollzeit

Zusammenfassung

AbbVie is seeking a hands-on Small Scale Cell Operations Leader to run manufacturing activities in the SSC facility, ensuring safe, compliant and on-schedule delivery of drug substance while meeting safety, quality, regulatory and site requirements.

You will lead a manufacturing team, plan resources, collaborate with API Operations and Technical Operations, drive continuous improvement, and prepare for regulatory inspections and audits.

Qualifikationen

• A degree or higher qualification in chemical engineering or related discipline.
• At least three years' experience in batch processing operations within an FDA- or HPRA-regulated industry.
• At least three years’ 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.

Aufgaben

• 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.

Ausbildung

Degree or higher qualification in chemical engineering or related discipline

Jobbeschreibung

AbbVie is seeking a hands-on Small Scale Cell Operations Leader to run manufacturing activities in the SSC facility, ensuring safe, compliant and on-schedule delivery of drug substance while meeting safety, quality, regulatory and site requirements.

You will lead a manufacturing team, plan resources, collaborate with API Operations and Technical Operations, drive continuous improvement, and prepare for regulatory inspections and audits.