Supervisor, Bioassay NPI

ABBVIE; Waterford; Vor Ort; EUR 65.000 - 90.000; Vollzeit

Zusammenfassung

AbbVie in Westport seeks a Supervisor, Bioassay NPI to oversee CBPA and ELISA testing for development and clinical products. This fixed-term 12-month contract focuses on release and stability testing aligned with global timelines, with cross-functional collaboration across QA, Microbiology, Chemistry, Production and Planning.

The role requires leading a skilled team, managing performance, training staff, and ensuring compliance with regulatory and corporate standards while supporting staff

Qualifikationen

• Minimum BSc in Biological Sciences.
• At least five years’ laboratory experience with proven team leadership.
• Knowledge of biologics manufacturing, bioassays, biochemistry and biostatistics in GMP setting.
• Experience in regulated environments and data integrity requirements.

Aufgaben

• Provide motivation to the team and take corrective action when required.
• Hold performance meetings in line with company policy.
• Recruit and onboard new team members.
• Maintain attendance and timekeeping records.
• Train and certify new staff members.
• Ensure activities comply with QA, EHS, and corporate standards.
• Plan capacity and recruit to meet business needs.
• Coach Analytical Technology Specialists and support IDPs.
• Provide data to support product release and stability programmes.
• Attend department and OPEX meetings and review documents.

Kenntnisse

Team leadership

Regulatory awareness

Ausbildung

BSc in Biological Sciences

Jobbeschreibung

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

The Westport Bioassay department requires highly skilled personnel to fulfil several critical tasks. The Supervisor, Bioassay NPI is responsible for the oversight and operation of the Bioassay QC NPI laboratory. The group performs Cell-Based Potency Assay (CBPA) and ELISA testing of development and clinical products generated by Biologics Development Manufacturing and is responsible for release and stability testing following assay transfer and validation from PDS&T. This is for a fixed term contract of 12 months.

The supervisor ensures that release and stability testing for products in the development pipeline is scheduled and completed in line with global request timelines, supporting uninterrupted clinical supply and the achievement of project milestones. The role also communicates results to key stakeholders, schedules ancillary laboratory activities—including critical reagent screening and qualification, laboratory housekeeping, paperwork review, and procedural updates—and supports personnel development, talent management, and succession planning within the team.

• Provide motivation to the team and take appropriate corrective action on individual or team performance where required through effective communication.
• Hold performance meetings in accordance with company policy.
• Take an active role in the recruitment of team members.
• Update Kronos and take appropriate action where an individual’s attendance or timekeeping is below the expected standard.
• Actively participate in the training and certification of new employees.
• Ensure all activities are completed in line with regulatory requirements, including QA and EHS requirements, and corporate standards.
• Maintain capacity in line with business needs, including recruiting staff and managing constraints appropriately.
• Coach and develop Analytical Technology Specialists to support succession planning and Individual Development Plans (IDPs).
• Provide required data in line with testing timelines to support product release and the global stability programme.
• Provide team KPI data.
• Attend departmental and OPEX meetings.
• Review and approve local and corporate documents.
• Work directly with Microbiology, Chemistry, Production, QA, and Planning to ensure the timely release of development products.
• Ensure the timely review of data generated within the team.

Qualifications

• Qualification in Biological Sciences, with a minimum of a BSc.
• At least five years’ experience working in a laboratory setting with proven team leadership skills.
• Knowledge of biologics manufacturing, bioassays, biochemistry, and biostatistics, with experience in a GMP testing laboratory.
• Clear understanding of working within a regulated environment.
• Good organisational and interpersonal skills.
• Willingness to upskill and collaborate.
• Ability to support priority projects and meet timelines.

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 applicants seeking a reasonable accommodation, click here to learn more: