Biologics Manufacturing Lead (Shift Role)

AbbVie Inc.; Sligo; On-site; EUR 70,000 - 95,000; Full time

Job summary

AbbVie Ballytivnan site in Ireland is seeking a Manufacturing Lead to guide and develop a biologics fill-finish team. This shift-based role requires days and evenings rotations and a strong emphasis on product quality and regulatory compliance.

You will lead compounding, filling, lyophilization, equipment prep, formulation and processing, coach the team, drive cost-effective quality, and collaborate with program management, supply chain, and quality to meet objectives and audits.

Qualifications

• Minimum of 5 years experience in batch processing, automation, commissioning, and/or validation in an FDA/HHPRA-regulated industry.
• A minimum of 1 year of 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

Commissioning

Validation

Supervisory

cGMP

Contamination control

Education

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

Advanced degree preferred

Job description

AbbVie Ballytivnan site in Ireland is seeking a Manufacturing Lead to guide and develop a biologics fill-finish team. This shift-based role requires days and evenings rotations and a strong emphasis on product quality and regulatory compliance.

You will lead compounding, filling, lyophilization, equipment prep, formulation and processing, coach the team, drive cost-effective quality, and collaborate with program management, supply chain, and quality to meet objectives and audits.