Director, CMC Product Development - Late Stage, Operations
About The Position
The Product Development Director (PDD) is a member of AbbVie’s Operations Strategy & Pipeline Leadership team within the Product Development, Science & Technology organization. Reporting to a Therapeutic Area Lead, the PDD is responsible for pipeline programs from a Chemistry, Manufacturing, and Controls (CMC) perspective, leading the Product Presentation and Device Strategy Team and developing CMC strategies for late-stage assets that align with clinical and regulatory development strategies. The role spans multiple modalities—including small molecules, biologics such as proteins, gene therapies and toxins, and antibody-drug conjugates—and presentations such as oral doses, parenteral products and devices. The PDD creates CMC development plans in collaboration with line functions, aligns strategy with Clinical, Regulatory and Commercial functions at the Asset Strategy Team, and represents CMC at asset-level governance and within Operations. The role supports late-stage development and launch readiness, communicates development and regulatory risks, and seeks feedback from CMC leadership.
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 PhD and at least 10 years of relevant CMC experience.
- Experience sufficient to effectively manage global teams and CMC activities across science, technology, quality, regulatory and compliance requirements, budget and resources.
- 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 and device development process.
- Interdisciplinary CMC experience and expertise.
- Negotiating, influencing and leadership skills, with the ability to apply entrepreneurial thinking and make sound business decisions.
Nice To Haves
- Multiple product-development experiences leading a CMC team through regulatory submissions, preferably NDA, BLA, PMA or 510(k) submissions.
- Familiarity with device regulatory requirements.
Responsibilities
- Represent CMC areas on the Asset Strategy Team, serve as spokesperson for the CMC project team, and ensure information flows between the team 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 strategies and plans aligned with corporate business objectives and applicable regulatory and compliance requirements.
- Manage multiple projects, contribute to prioritization, negotiate for additional resources, influence timelines, and identify ways to conserve resources and improve efficiency.
- Provide feedback to CMC management on resource and talent opportunities.
- Review contracts with external partners and consultants; develop budgets with the Asset Strategy Team and obtain resources from functional areas.
- Be accountable for project success and overall CMC quality, and ensure timely execution of project plans with respect to science, technology, compliance and cost effectiveness.
- Represent AbbVie in high-profile partnerships and collaborations with other pharmaceutical and biotechnology companies and at Joint Development Committee level, driving 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, and stay current with global technical, regulatory and compliance developments and industry practices.
- Keep CMC Management informed of plans and risks through regular communications and periodic reviews throughout development and in support of global filings, approvals and launches.
- Ensure high morale in 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.
- Eligible to participate in long-term incentive programs.
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What This Job Offers
Job Type
Full-time
Career Level
Director
