Director, API Development & Tech Transfer

AbbVie Inc.; Chicago (IL); Hybrid; USD 180,000 - 260,000; Full time

Job summary

AbbVie Inc. seeks a Director of Operations Product Development, Science & Technology (PDS&T) to set vision, plan and lead manpower, facilities and budgets to keep projects on track, aligning development with manufacturing and customer requirements.

You will lead a diverse staff, liaise between R&D and contract manufacturers, and drive seamless scale-up from pilot to full-scale manufacturing with a focus on quality and regulatory compliance.

Qualifications

• 10+ years of API development/manufacturing, formulation, analytical chemistry and/or technical services in pharma.
• At least 6+ years of managerial experience in the pharmaceutical industry.
• Strong background in drug development, marketed product support and regulatory/compliance fields.

Responsibilities

• Manage strategies, assessment, planning, decision-making, and risk management of API and dosage form projects.
• Provide mature, credible CMC leadership at AbbVie.
• Direct a cross-functional staff to meet scientific, regulatory and commercial standards.
• Evaluate new technology and integrate regulatory guidance into strategy.
• Develop cost estimates, business plans, timelines and contingency plans.
• Recruit resources and make go/no-go decisions for projects.
• Interface with R&D and Operations; engage with external manufacturers and customers.

Skills

CMC leadership

Drug development

Regulatory knowledge

Cross-functional leadership

Education

Master’s Degree or equivalent related experience

PhD or equivalent experience

Job description

AbbVie Inc. seeks a Director of Operations Product Development, Science & Technology (PDS&T) to set vision, plan and lead manpower, facilities and budgets to keep projects on track, aligning development with manufacturing and customer requirements.

You will lead a diverse staff, liaise between R&D and contract manufacturers, and drive seamless scale-up from pilot to full-scale manufacturing with a focus on quality and regulatory compliance.