Manufacturing Lead

Job Description

Our Ballytivnan team invites Manufacturing experts to join our growing team as a Manufacturing Lead. In the role, you will have the opportunity to lead, develop and guide team members both technically and professionally.

This is a shift-based role, you will be required to work rotational shifts between days and evenings.

Delivering high levels of customer service, in this role, you will ensure the quality of the product, comply with all regulatory requirements, achieve desired financial performance, including cost reductions, and build a high-performance culture for the team.

Roles and 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.

Qualifications

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.

Additional Information

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:

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