CMC Product Development Director — Late-Stage Strategy

AbbVie; North Chicago (IL); On-site; USD 180,000 - 280,000; Full time

Benefits offered by this job

Medical/dental/vision insurance

401(k) plan

Long-term incentive programs

Job summary

AbbVie seeks a Product Development Director (PDD) to lead CMC development and strategy within the Operations Strategy & Pipeline Leadership team. You will guide late-stage asset programs, align with regulatory and clinical plans, and present CMC perspectives at governance forums.

You will manage budgets, collaborate with cross-functional partners, ensure quality, and drive risk management for regulatory filings and launches across modalities, including small molecules, biologics, and devices.

Qualifications

• Bachelor’s/Masters/PhD with extensive CMC leadership and global regulatory exposure.
• Experience leading CMC teams through regulatory submissions (NDA/BLA/PMA/510K preferred).
• Excellent scientific writing and verbal communication skills.
• Strong regulatory knowledge and familiarity with CMC development approaches (device regulatory knowledge preferred).
• Knowledge of pharmaceutical sciences and drug/device development process.
• CMC interdisciplinary experience and leadership capabilities.
• Strong negotiating, influencing and leadership skills.

Responsibilities

• Represent all CMC areas on the AST and coordinate with line functions.
• Integrate drug substance/product and device inputs into CMC strategies aligned with business objectives.
• Manage multiple projects, prioritize resources, and optimize time and budget.
• Review contracts with external partners and manage budget with AST.
• Represent AbbVie in high-profile partnerships and development decisions.
• Foster scientific thinking, creativity, and high-quality deliverables.
• Ensure regulatory, health, safety and environmental compliance.
• Report plans and risks to CMC leadership and support global filings/launches.

Skills

Scientific writing

Regulatory knowledge

Leadership

Negotiation

Cross-functional collaboration

Education

Bachelor’s Degree with 18+ years CMC experience

Master’s Degree with 16+ years CMC experience

PhD with 10+ years CMC experience

Job description

AbbVie seeks a Product Development Director (PDD) to lead CMC development and strategy within the Operations Strategy & Pipeline Leadership team. You will guide late-stage asset programs, align with regulatory and clinical plans, and present CMC perspectives at governance forums.

You will manage budgets, collaborate with cross-functional partners, ensure quality, and drive risk management for regulatory filings and launches across modalities, including small molecules, biologics, and devices.