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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

The Clinical Laboratory Operations Leader is responsible for leading and facilitating the operations of a cGMP Clinical Laboratory. This role ensures that all safety, regulatory, and procedural requirements are met, while overseeing the production quality of clinical supplies. The Leader ensures compliance with build protocols and maintenance of lab equipment and materials. Additionally, the Leader supports activities in the Process Development Lab when the Clinical Lab is idle.

Supervisory Responsibility

• Supervise the work/activities within the Clinical Lab through matrix management.
• No direct reports.

Key Duties and Responsibilities

People

• Responsible for the effective deployment of team members and the delegation of tasks to meet project team schedules and cleanroom environmental requirements.
• Ensure team members are trained to required standards and protocols for builds.
• Maintain presence on the floor to promote a culture of zero safety incidents, complying with all Environmental, Health, and Safety (EHS) requirements.
• Proactively review daily work activities to highlight any high-risk activities.

Compliance and Operational

• Coordinate shift activities effectively to meet project timelines.
• Enforce quality rules and ensure compliance with all procedures and protocols to maintain product quality.
• Manage, with support functions, any compliance issues that could impact lot completion.
• Oversee the expense re-classification of all costs associated with project-based studies.
• Establish and monitor a supply inventory system for ordering necessary items for lab/project activities.

Technical Oversight and Assistance

• Provide oversight and hands-on assistance with tissue processing activities, including:
  • Re-assembly, adjustment, operation, and maintenance of associated equipment.
  • Tissue assessment for specific material properties.
  • Aseptic execution of Research and Development (R&D) lab processing activities such as manual solution changes, cutting tissue to final product size, and final packaging.

Minimum Qualifications:

•     Associates Degree

•     Ability to communicate and document technical matters with Maintenance Engineering, Quality, Senior Management Team and Auditors.

•     Demonstrate a clear understanding of ISO, regulatory requirements and of GMP standards through compliance of the Quality Policy

•     Computer proficiency (including MS Office Suite) and scheduling experience required

•     Working knowledge of safety, quality systems, and cGMPs is required

•     Excellent oral and written communication skills

Preferred Qualifications:

•     Bachelor's Degree

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​​

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• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.​​

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​​

• This job is eligible to participate in our short-term incentive programs. ​​

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Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion.  It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html 

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html