Clinical Production Team Leader

2 weeks ago


North Chicago, Illinois, United States AbbVie Full time

Company Overview

At AbbVie, our mission is to innovate and provide transformative medicines and solutions that tackle significant health challenges today while preparing for the medical hurdles of tomorrow. We aim to make a profound difference in the lives of individuals across various therapeutic domains, including immunology, oncology, neuroscience, and eye care, alongside our offerings in the Allergan Aesthetics portfolio. For further insights about AbbVie, please visit our official website.

Position Summary

The Clinical Production Team Leader is accountable for overseeing and mentoring operational staff involved in the production of clinical or commercial goods. This role collaborates closely with fellow supervisors to ensure seamless operations. The position entails the precise and prompt completion of production-related cGMP documentation and supports the transfer, planning, implementation, and ongoing maintenance of manufacturing processes and protocols. The leader is responsible for optimizing the utilization of materials, equipment, and personnel to produce high-quality products.

Key Responsibilities

- Establishes weekly objectives and schedules while prioritizing tasks for team members.

- Reviews the weekly production agenda and priorities to allocate unit assignments and identify critical actions.

- Evaluates all materials and batch records necessary to support both day and off-shift operations.

- Provides hands-on training to facilitate formal technical and GMP training. Ensures operator training files are aligned with the processes they are expected to execute.

- Monitors operator training documentation and collaborates with compliance specialists to maintain up-to-date records.

- Engages with Quality Assurance and Subject Matter Experts to address exceptions and reviews new batch records and SOPs.

- Works alongside the technology transfer team to integrate new processes into the facility.

- Coordinates interdepartmental efforts to resolve work orders, dispensing, preventative maintenance, QC, and documentation challenges, enhancing communication across all levels.

- Ensures adherence to direct materials and overtime budgets.

- Provides supervision primarily to skilled non-exempt and junior exempt personnel, acting as an advisor and mentor for less experienced team members.

- Conducts staff performance evaluations.

- Guarantees compliance with all relevant local, state, and federal regulatory standards, including but not limited to OSHA's Process Safety Management (PSM) standard and EPA's Risk Management Planning (RMP) rule.

- Fosters a safety-oriented culture by directing efforts to minimize or eliminate operational injuries, product or equipment loss, and unnecessary expenses by ensuring all facilities and equipment meet AbbVie's safety, security, and hygiene standards.

Qualifications

- A Bachelor’s degree or equivalent is required; a minimum of eight years of experience in manufacturing or production processes is essential.

- Proficiency in computer systems and scheduling is necessary, along with strong writing capabilities.

- A solid understanding of safety protocols, quality systems, and cGMP regulations is mandatory.

- Familiarity with industrial automation, including distributed control and PLC-based systems, is preferred.

- Knowledge of equipment and facilities validation is advantageous.

Additional Information

AbbVie is dedicated to operating with integrity, fostering innovation, transforming lives, serving our community, and embracing diversity and inclusion. We are committed to employing qualified individuals without discrimination based on race, color, religion, national origin, age, sex, physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, veteran status, or any other legally protected status.



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