Supervisor, QC Bioassay

AbbVie Inc.; Town of Westport (WI); On-site; USD 90,000 - 120,000; Full time

Job summary

AbbVie Westport seeks a Supervisor for the QC Bioassay lab to oversee batch release and stability testing, ensuring timely product releases and compliance with QA/EHS. You will chair Tier 1 meetings, manage staffing, and develop talent across Analytical Technology Specialists.

The role requires 5+ years in a lab, deep GMP knowledge, and strong collaboration with Microbiology, Chemistry, Production, QA and Planning to deliver high-quality commercial products.

Qualifications

• 5+ years in a laboratory setting.
• Knowledge of biologics manufacturing, bioassays, biostatistics, and GMP testing.
• Understanding of working within a regulated environment.
• Strong organizational and interpersonal skills; willingness to up-skill.

Responsibilities

• Provide motivation and corrective action for team performance.
• Hold performance meetings and assist with recruitment of team members.
• Update Kronos and manage attendance/timekeeping below standard.
• Train and certify new employees.
• Ensure activities comply with QA, EHS and corporate requirements.
• Coordinate with Microbiology, Chemistry, Production, QA and Planning for timely releases.
• Review data and provide KPI data.

Skills

Team leadership

Biologics manufacturing

Bioassays

Biostatistics

GMP knowledge

Regulated environment

Tools

Kronos

Job description

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 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 andexperience within a GMP testing laboratory
• Clear understanding of working within a regulated environment
• 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.