Biologics (Manufacturing) Technical Shift Lead

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 strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube and LinkedIn. 

Our pipeline holds the promise of medicines and solutions that could treat 1.6+ billion people. Learn more about bringing this promise to life.

Welcome to AbbVie!
AbbVie employees work every single day to discover and address many of the world's most pressing health challenges. Our work helps people live better lives. When you have patients depending on your solutions, you look for the best people, and when we find them, we make it our business to treat them well.

Our Westport team invites technical experts to join our NPI Biopharma operations team as our new Technical Shift Leader. In the role, you will have the opportunity to lead an established team developing and guiding its members technically and professionally.  

This is a shift based role, you will be required to work 12-hour shifts between days and nights on a monthly rotation. 

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.

If great benefits, a defined career path, and work-life balance are important in your next career move, then read on to find out more:

Key activities:

• 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.

So what will you need to be successful in this role?

Education and preferred experience:

• Minimum of 5 years experience in batch processing, automation, commissioning, and/or validation in an FDA/HHPRA-regulated industry. 
• 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 required for this role.
• Comprehensive understanding of contamination control principles and regulatory expectations for aseptic processing.
• Technical background in pharmaceutical, biologics, or similar industries.
• A minimum of 1 year of direct supervisory experience in a team environment is preferred
• Possess strong technical knowledge and application of concepts, practices, and procedures. Works on problems of complex scope where analysis of situations or data involves multiple competing factors. Exercises judgment and advises the appropriate actions

All your information will be kept confidential according to EEO guidelines.

AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion.  It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.