Supervisor, Bioassay NPI

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.

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 activitiesincluding critical reagent screening and qualification laboratory housekeeping paperwork review and procedural updatesand 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 individuals 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.
• 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.

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. 

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Work :

No

Employment Type :

Full-time