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Technical Shift Leader - API Manufacturing

On-site Full-time

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Experience Level

Experience

Qualifications

Required Qualifications:Degree, Master's, or PhD in Life Sciences or Process/Chemical Engineering. Job/Technical Skills:A minimum of 5 years’ experience in batch processing, automation, commissioning, and validation within an FDA/HPRA regulated industry. Comprehensive understanding of cGMP and regulatory requirements pertinent to the pharmaceutical sector. Proven track record as a technical leader in process engineering, formulations, or technical transfers. Experience with start-ups and/or new product introductions in pharmaceutical environments, with strong project management skills to lead these initiatives. Demonstrated ability to deliver projects on time, within budget, and meeting quality standards. At least 1 year of supervisory experience in a team environment.

About the job

Purpose:

The Technical Shift Leader for API is responsible for ensuring the production of API material aligns with organizational requirements and complies with all relevant regulations.

 

This role involves leading the API Small Scale (SSC) manufacturing team in a pharmaceutical processing facility, ensuring adherence to safety, regulatory, and operational standards.

 

Key Responsibilities:

  • Oversee and implement pharmaceutical processing activities within the API SSC and associated locations to achieve operational goals.
  • Provide leadership, motivation, and guidance to the manufacturing team, clearly communicating tasks and objectives to optimize performance.
  • Ensure timely and accurate verification and updates of manufacturing control system transactions.
  • Serve as the primary technical contact for the API SSC Business Unit, with shift technicians reporting directly to you.
  • Communicate departmental objectives to ensure cost-effective product delivery within the AbbVie Class A supply chain framework.
  • Collaborate with Supply Chain and Program Management to facilitate efficient planning, scheduling, and execution of commercial and NPI clinical manufacturing.
  • Resolve operational and project-related issues by engaging with team members and project stakeholders.
  • Drive operational excellence and meet key performance targets, including Overall Equipment Effectiveness (OEE) where applicable.
  • Maintain compliance with all safety, environmental, and quality-related SOPs.
  • Champion safety improvements and initiatives throughout the operations.
  • Review, amend, and implement changes to SOPs while managing Corrective and Preventive Actions (CAPAs).
  • Foster a culture of excellence and 'Right First Time' within the team.
  • Coordinate with relevant departments and customers during the introduction and execution of NPI projects.
  • Adhere to and promote all EHS & E standards, policies, and procedures.
  • Work closely with other Technical Shift Leaders to ensure safe planning and execution of interdepartmental activities.
  • Develop team members through appropriate training and performance evaluations.
  • Assist HR in managing employee relations issues.
  • Engage with internal and external customers regularly to address inquiries and clarify processes.

About AbbVie Inc.

AbbVie is a global biopharmaceutical company dedicated to discovering and delivering innovative medicines that tackle serious health challenges today and prepare for future medical needs. We focus on making a significant impact on patients' lives across key therapeutic areas such as immunology, oncology, neuroscience, and eye care, as well as offering products and services under our Allergan Aesthetics portfolio. To learn more about AbbVie, visit www.abbvie.com.

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