Director, CMC Product Development - Late Stage, Operations

AbbVie • North Chicago, IL

2d

About The Position

The Product Development Director (PDD) is a member of the Operations Strategy & Pipeline Leadership (OSPL) team within the Product Development, Science & Technology (PDS&T) organization and reports to a Therapeutic Area Lead. The PDD is responsible for late-stage pipeline programs from a Chemistry, Manufacturing, and Controls (CMC) perspective, leads the Product Presentation and Device Strategy Team (PPDST), and develops CMC strategies aligned with the clinical and regulatory development strategy set by the Asset Strategy Team (AST). Programs may span small molecules, biologics—including proteins, gene therapies, and toxins—and antibody drug conjugates. Product presentations may include oral dosage forms, parenteral products, and devices for therapeutics or aesthetics.

The PDD creates CMC development plans with line functions and ensures strategic alignment across Clinical, Regulatory, and Commercial enterprise functions at the AST. The role serves as the CMC spokesperson at asset-level governance, represents assets within Operations, and supports late-stage development and launch readiness. The PDD communicates development and regulatory risks and seeks feedback from CMC leadership. This position is accountable for project success and overall CMC quality, including delivery of high-quality science and technology, regulatory and compliance readiness, and effective management of timelines, budgets, and resources.

Requirements

• Bachelor’s degree and at least 18 years of experience in CMC functions; or a master’s degree and at least 16 years of relevant CMC experience; or a Ph.D. and at least 10 years of relevant CMC experience.
• Experience effectively managing global teams and CMC activities across science, technology, quality, regulatory and compliance requirements, budgets, and resources.
• Multiple product development experiences leading a CMC team through regulatory submissions.
• Good scientific writing and verbal communication skills.
• Good working knowledge of regulatory requirements and familiarity with relevant CMC development approaches.
• Knowledge of pharmaceutical sciences and the drug/device development process.
• Interdisciplinary CMC experience and expertise.
• Negotiation, influencing, and leadership skills.
• Creative, entrepreneurial thinking and the ability to make sound business decisions.

Nice To Haves

• Experience leading CMC teams through NDA, BLA, PMA, or 510(k) submissions.
• Familiarity with device regulatory requirements.

Responsibilities

• Represent all CMC areas on the Asset Strategy Team, serve as spokesperson for the CMC project team, and ensure information flows between the AST and line functions.
• Ensure high-quality science, technology, and deliverables, collaborating to meet global regulatory and quality requirements.
• Participate in interactions with Regulatory and Health Authorities.
• Evaluate and integrate drug substance, drug product, and device inputs into CMC team strategies and plans aligned with corporate business objectives.
• Manage multiple projects and contribute to project prioritization.
• Negotiate for additional resources when needed and influence project timelines to ensure required activities are completed.
• Implement creative approaches to conserve resources and improve efficiency in time and budget.
• Provide CMC management with feedback on resource and talent opportunities.
• Review contracts with external partners and consultants.
• Develop budgets with the AST and obtain resources from functional areas.
• Ensure timely execution of project plans and high-quality outcomes in science, technology, compliance, and cost effectiveness.
• Represent AbbVie in high-profile partnerships and collaborations, including at Joint Development Committee level, and drive development-program decisions.
• Promote scientific and entrepreneurial thinking, encourage creativity, and manage quality and results with respect to science, time, budget, and resources.
• Ensure compliance with regulatory, health, safety, and environmental requirements.
• Stay current with developments in global technical, regulatory, and compliance practices and the industry.
• Communicate plans and risks to CMC management through regular updates and periodic reviews throughout development and in support of global filings, approvals, and launches.
• Maintain a high level of morale within the CMC team.

Benefits

• Paid time off, including vacation, holidays, and sick time.
• Medical, dental, and vision insurance for eligible employees.
• 401(k) for eligible employees.
• Eligibility to participate in long-term incentive programs.

What This Job Offers

• Job Type: Full-time
• Career Level: Director