Supervisor, QC Bioassay

AbbVie; Westport; Vor Ort; CAD 90.000 - 120.000; Vollzeit

Zusammenfassung

AbbVie Westport is seeking a Supervisor for the QC Bioassay group to oversee cell-based potency assays and ELISA testing of commercial products. You will chair Tier 1 meetings, manage staffing, and ensure timely release data while maintaining QA/EHS compliance.

Ideal candidates have 5+ years in a regulated lab, strong bioassay/biostatistics knowledge, and proven leadership. This role emphasizes collaboration with Microbiology, Chemistry, Production, and QA teams at the Westport site.

Qualifikationen

• 5+ years of experience in a laboratory setting.
• Knowledge of biologics manufacturing, bioassays and biostatistics.
• GMP testing laboratory experience.
• Experience working in a regulated environment.
• Excellent conflict handling and communication skills.
• Strong organizational and interpersonal abilities.
• Willingness to up-skill and collaborate.
• Ability to support priority projects to meet timelines.

Aufgaben

• Chair and run daily Tier 1 meetings and oversight of lab activities.
• Schedule ancillary laboratory duties including reagent screening and qualifications.
• Maintain housekeeping and review paperwork and SOP updates.
• Develop personnel and succession planning for the team.
• Provide KPI data and coordinate with QA, Microbiology, Chemistry and Production.
• Ensure timely product release and data availability for timelines.

Kenntnisse

Laboratory experience

Biologics manufacturing

Bioassays

Biostatistics

GMP testing

Regulatory environment

Conflict resolution

Communication skills

Organization

Interpersonal skills

Continuous learning

Team collaboration

Project support

Jobbeschreibung

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.

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Job Overview

The QC Bioassay commercial department requires highly skilled personnel to fulfil several critical tasks. The role is responsible for the oversight and operation of the lab.

Activities of the group include Cell Based Potency Assay (CBPA) and ELISA testing of commercial products manufactured within the AbbVie network. The group is responsible for release and stability testing of commercial products and supporting commercial process changes.

The Supervisor ensures delivery of batch release targets which feed into overall plant performance metrics. Outside of routine scheduling, the role entails interfacing with multiple departments within the AbbVie Westport site, in addition to corporate colleagues, and being able to facilitate ad hoc requests for data management/review.

The successful candidate will be responsible for chairing and running daily Tier 1 meetings, scheduling ancillary laboratory duties including critical reagent screening/qualifications, laboratory housekeeping, review of paperwork and procedural updates where required.

The Supervisor of the lab is also responsible for personnel development, talent management and succession planning of their team.

Key Responsibilities

• + Provide motivation to the team and take appropriate corrective action on individual/team performance where required through effective communication.
• + Hold performance meetings according to company policy.
• + Take an active role in the recruitment of team members.
• + Update Kronos and take appropriate action where an individual's attendance/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 (QA and EHS) and corporate requirements.
• + Maintain capacity in line with business needs, including the recruitment of staff, and ensure any constraints are managed appropriately.
• + Coach and develop Analytical Technology Specialists to support the company's succession planning and Individual Development Plans (IDPs).
• + Provide required dates in line with testing timelines to support product release and the global stability programme.
• + Provide team KPI data.
• + Attend Departmental and OPEX meetings.
• + Provide review and approval of local and corporate documents.
• + Work directly with other departments, including Microbiology, Chemistry, Production, QA and Planning, to ensure the timely release of commercial products.
• + Ensure timely review of data generated within the team.

Qualifications

• + Experience working in a laboratory setting of 5+ years
• + Knowledge of biologics manufacturing, bioassays, biostatistics and experience within a GMP testing laboratory
• + Clear understanding of working within a regulated environment
• + Excellent conflict handling skills
• + Clear communication skills required.
• + Good organizational skills and interpersonal skills required.
• + Willingness to up-skill and collaborate.
• + Ability to support priority projects to 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 only