Technical Shift Lead

Biopharma Careers; Town of Westport (WI); On-site; USD 85,000 - 110,000; Full time

Job summary

AbbVie in Westport, WI invites an experienced Technical Shift Leader to guide a biologics fill-finish manufacturing team. You will lead procedures from compounding through processing, ensuring quality, regulatory compliance, and cost-conscious operations.

The role requires 12-hour shift work on a rotating schedule, with focus on safety, training, and continuous improvement in a regulated GMP environment.

Qualifications

• Minimum of 5 years experience in batch processing, automation, commissioning, and/or validation in an FDA/HHPRA-regulated industry.
• At least 1 year of direct supervisory experience is preferred.
• Bachelor's degree in chemistry, pharmacy, engineering or related 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

Leadership

Supervisory

Batch processing

Aseptic processing

Regulatory knowledge

cGMP

Biologics

Education

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

Advanced degree preferred

Job description

Company Description

About AbbVie

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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube.

Job Description

Our Westport team invites technical experts to join our growing team as a Technical Shift Leader. 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 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.

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

• 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

Bring your expertise, make it matter.

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