Lead Bioassay NPI Lab Supervisor | GMP & People Leader

AbbVie Inc.; Northern (KY); Hybrid; USD 90.000 - 130.000; Vollzeit

Zusammenfassung

AbbVie in Westport, Kentucky is seeking a Supervisor, Bioassay NPI to oversee the Bioassay QC NPI laboratory. The role leads CBPA and ELISA testing for development and clinical products, ensuring release and stability testing aligns with global timelines.

You will motivate and manage a small team, coordinate training and certification, review data, and collaborate with Microbiology, Chemistry, Production, QA and Planning to enable timely product release while maintaining QA, EHS and regulatory

Qualifikationen

• 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.
• Excellent conflict-handling skills.
• Clear communication skills.
• Good organisational and interpersonal skills.
• Willingness to upskill and collaborate.
• Ability to support priority projects and meet timelines.

Aufgaben

• 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.

Kenntnisse

Team leadership

Regulatory compliance

Communication

Training and development

Data reporting

Ausbildung

Biological Sciences (BSc)

Tools

Kronos

Jobbeschreibung

AbbVie in Westport, Kentucky is seeking a Supervisor, Bioassay NPI to oversee the Bioassay QC NPI laboratory. The role leads CBPA and ELISA testing for development and clinical products, ensuring release and stability testing aligns with global timelines.

You will motivate and manage a small team, coordinate training and certification, review data, and collaborate with Microbiology, Chemistry, Production, QA and Planning to enable timely product release while maintaining QA, EHS and regulatory