Director, Pharmaceutical Development (API Pilot Plant Head)

Purpose:

• Lead the API Pilot Plant Organization which is responsible for all API deliveries (small molecules, drug-linkers and ADCs) to support pre-clinical and clinical studies, and drug product development activities.
• The pilot plant is also responsible for producing API primary stability batches, demonstrating the commercial process and control strategy, and generating the process knowledge and experience to enable a smooth Tech Transfer to commercial sites.
• Provide strategic leadership to all functions in the Pilot Plant for successful execution of pipeline deliverables, talent development and to drive efficiency and sustainability.

Responsibilities:

• Ensure manufacturing of API clinical supplies in compliance with cGMP and AbbVie Quality and Regulatory standards, and consistent with project timelines.
• Lead the Pilot Plant Operations (manufacturing and materials management), Technical Operations and Engineering organizations to ensure successful execution of pipeline deliverables.
• Work collaboratively with partner functions, including Process R&D scientific organizations, QA and EHS to align on priorities and timelines, and to ensure safety and regulatory compliance.
• Ensure the development of strategies that drive technical excellence and innovation to improve future capabilities and productivity of the Pilot Plant and Process R&D.
• Responsible for leadership and technical development of employees within the organization to develop successful future leaders.
• Create a culture of empowerment that drives collaboration, engagement and accountability in the organization.
• Lead the talent management process to ensure employee development and effective succession planning. Actively drive performance excellence.
• Ensure projects and operating costs are managed within the approved capital and expense budgets for the pilot plant.
• Build strong relationships with internal and external partners, including drug product clinical manufacturing, TPMs and AbbVie commercial manufacturing sites.
• Benchmark with industry peers and implement strategies, new technologies and best practices to enable the pipeline, enhance efficiency and drive long term success.
• Champion innovative approaches and enabling technologies (flow chemistry, PAT, etc.) that have potential to deliver impactful solutions for API processes.
• Identify strategies to optimize allocation of key resources such as budget, capital, facilities and/or personnel to meet goals and to give AbbVie a competitive advantage.

Qualifications:

• PhD in Chemical Engineering or a related discipline and 15 years of experience in the Pharmaceutical Industry, or Bachelor's/ Master's degree and 20 years of experience
• Demonstrated capability in leading large organizations
• Strong experience in API manufacturing operations
• Demonstrated capability to solve critical business and scientific problems
• Demonstrated ability to grow the capabilities of an organization and develop people into future leaders

Equal Opportunity Employer Minorities/Women/Veterans/Disabled