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 Product Development, Science & Technology. Reporting to a Therapeutic Area Lead, the PDD is responsible for pipeline programs from a Chemistry, Manufacturing, and Controls (CMC) perspective. The role leads the Product Presentation and Device Strategy Team and develops CMC strategies for late-stage assets aligned with clinical and regulatory development strategies. Programs may span small molecules, biologics—including proteins, gene therapies, and toxins—and antibody drug conjugates, with oral, parenteral, and device presentations. The PDD creates CMC development plans with line functions and ensures cross-functional alignment with Clinical, Regulatory, and Commercial teams at the Asset Strategy Team level. The role represents CMC at asset-level governance and within Operations, supporting late-stage development and launch readiness. The PDD communicates development and regulatory risks and seeks feedback from CMC leadership, while being accountable for project execution, CMC quality, science, compliance, cost effectiveness, and delivery of project plans.
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 sufficient to effectively manage global teams and CMC activities involving science, technology, quality, regulatory and compliance requirements, budget, 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.
- Ability to apply creative, entrepreneurial thinking and 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 among the Asset Strategy Team and line functions.
- Ensure high-quality science, technology, and deliverables, and collaborate to support compliance with 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, contribute to project prioritization, negotiate for additional resources, and influence project timelines to ensure required activities are completed.
- Implement approaches to conserve resources and improve efficiency in time and budget, and provide CMC management with feedback on resource and talent opportunities.
- Review contracts with external partners and consultants; develop budgets in collaboration with the Asset Strategy Team and obtain resources from functional areas.
- Ensure timely execution of project plans and the overall CMC quality, scientific and technical quality, compliance, and cost effectiveness of projects.
- Represent AbbVie in high-profile partnerships and collaborations with other pharmaceutical and biotechnology companies, 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, 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.
- Support high morale within the CMC team.
Benefits
- Paid time off, including vacation, holidays, and sick leave.
- Medical, dental, and vision insurance for eligible employees.
- 401(k) for eligible employees.
- Eligibility to participate in long-term incentive programs.
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What This Job Offers
Job Type
Full-time
Career Level
Director
