Biologics Manufacturing Shift Lead (12h)

AbbVie; Westport; On-site; EUR 65,000 - 90,000; Full time

Job summary

AbbVie Westport is seeking a Technical Shift Leader to lead, develop and guide team members technically and professionally in a biologics fill-finish facility. This is a shift-based role with 12-hour days and nights on a monthly rotation.

You will ensure product quality, regulatory compliance, cost targets, and a high-performance culture while coordinating with QA, program management, supply chain and engineering to plan and execute manufacturing and related activities.

Qualifications

• Minimum 5 years experience in batch processing, automation, commissioning, and/or validation in an FDA/HHPRA-regulated industry.
• Minimum 1 year direct supervisory experience in a team environment is preferred
• Bachelor’s degree in chemistry, pharmacy, engineering or a related scientific field is required; an advanced degree is preferred.
• Detailed knowledge of cGMP and regulatory requirements relating to the pharmaceutical industry is essential.
• Comprehensive understanding of contamination control principles and regulatory expectations for aseptic processing.
• Technical background in pharmaceutical, biologics, or similar industries.

Responsibilities

• Act as your team's key point of contact and technical expert.
• Lead and support your team to deliver compounding, filling, lyophilization, equipment preparation, formulation, buffer preparation and processing activities in the biologics fill-finish facility to meet clearly stated operating objectives.
• Coach & mentor your manufacturing team to maximize its effectiveness through clear and effective communication.
• Promote and develop a culture of contamination control and compliance with aseptic best practices.
• Communicate departmental goals to provide cost-effective quality compliant products in a safe, effective manner.
• Collaborate with program management, supply chain, technical operations, quality, and engineering groups to ensure effective planning, scheduling and execution of commercial and NPI clinical manufacturing.
• Resolve operations/project issues with team members, project customers, and others as appropriate.
• Drive operations excellence and key operations targets, including OEE where applicable.
• Provide direct interface as a subject matter expert with the QA department to interact with HPRA, FDA and applicable health authorities and internal audits.

Skills

Batch processing

Automation

Supervisory experience

cGMP knowledge

Regulatory liaison

Education

Bachelor’s degree in chemistry, pharmacy, engineering or related field

Job description

AbbVie Westport is seeking a Technical Shift Leader to lead, develop and guide team members technically and professionally in a biologics fill-finish facility. This is a shift-based role with 12-hour days and nights on a monthly rotation.

You will ensure product quality, regulatory compliance, cost targets, and a high-performance culture while coordinating with QA, program management, supply chain and engineering to plan and execute manufacturing and related activities.