API Small Scale Cell Operations Leader

AbbVie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow.

We are looking for a Small Scale Cell Operations Leader to lead and facilitate manufacturing operations within our Small Scale Cell (SSC) facility. In this role, you will help deliver drug substance material in line with business needs while ensuring that operations meet all applicable safety, quality, regulatory and organisational requirements.

This is a hands-on manufacturing leadership opportunity with responsibility for team performance, operational delivery, compliance and continuous improvement. You will collaborate closely with API Operations, Technical Operations and other site partners, while providing technical leadership and guidance on SSC manufacturing activities.

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.
• 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.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html