Director, CMC Product Development

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

Job summary

AbbVie in Chicago is seeking a Director, CMC Product Development to lead the CMC strategy across late discovery through clinical development and transfer to manufacturing. You will serve as the single CMC spokesperson for assets, coordinating across CMC, Regulatory, Quality, Clinical, and Commercial teams while mentoring other leaders.

The role requires deep CMC expertise, strategic thinking, and the ability to influence without formal authority in a highly matrixed environment.

Qualifications

• Deep experience in pharmaceutical product development and CMC strategy.
• Ability to lead and influence matrixed teams without formal authority.
• Strong written and verbal communication across technical and non-technical audiences.
• Understanding of global regulatory and quality requirements across development stages.

Responsibilities

• Serve as the CMC leader and spokesperson on the Asset Strategy Team (AST).
• Lead cross-functional Product Presentation and Device Strategy teams (PPDST) and CMC teams.
• Develop, communicate, and drive the integrated CMC strategy and development plan.
• Translate complex CMC topics into clear messages for asset teams and senior leaders.
• Build relationships across CMC, Clinical, Regulatory, Quality, Operations, and external partners.
• Mentor and develop other CMC leaders and team members.
• Oversee a portfolio of programs across modalities and drive execution across the asset lifecycle.

Skills

CMC Strategy

Cross-functional Leadership

Drug Development

Regulatory Knowledge

Scientific Communication

Education

Bachelor's degree in related field

PhD or MD preferred

Job description

Company Description

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.

Job Description

As a Director, CMC Product Development, you will bring together scientific insight, enterprise perspective, and cross-functional leadership to help transform promising assets into differentiated medicines. As a key member of the Asset Strategy Team (AST) and leader of the CMC team, you will develop and drive an integrated CMC strategy that enables the overarching asset strategy. Serving as the single CMC spokesperson and integrator for the asset, you will connect expertise across the enterprise to drive alignment, informed decisions, and successful product development. This highly visible role offers a unique opportunity to lead multidisciplinary teams, influence asset-level strategy and investment decisions, and engage with senior leaders, external partners, and global health authorities from late discovery through clinical development and transfer to commercial manufacturing. Through scientific judgment, enterprise leadership, and matrix influence, you will navigate complexity, manage risks, align stakeholders, and help advance innovative therapies that meaningfully impact patients’ lives.

0-3 direct reports. Scope: from late-stage Discovery through clinical development to technology and process transfer to commercial manufacturing sites.

Responsibilities:

• Serve as the CMC leader, integrator, and spokesperson on the Asset Strategy Team (AST), connecting CMC strategy with the overarching asset strategy and ensuring clear, timely, and effective communication across the AST, CMC functions, and key stakeholders.
• Lead and inspire highly matrixed, cross-functional Product Presentation and Device Strategy teams (PPDST) and CMC teams, creating clarity of purpose, aligning diverse perspectives, facilitating effective decision-making, and building a collaborative and accountable team culture.
• Develop, communicate, and drive the integrated CMC strategy and development plan for complex assets, translating scientific and technical considerations into clear strategic choices, priorities, timelines, risks, and recommendations for teams and senior leaders.
• Communicate with impact across organizational levels, translating complex CMC topics into clear messages and recommendations, proactively surfacing risks and opportunities, and enabling informed decisions by asset teams, senior leaders, and governance bodies.
• Act as a connector across the organization and throughout the development lifecycle, from late discovery through clinical development and technology transfer to commercial manufacturing. Build strong relationships and alignment across CMC, Clinical, Regulatory, Quality, Operations, Preclinical Safety, ADME, Commercial, external partners, and other stakeholders, while mentoring and developing other CMC leaders and team members.
• Build and sustain trust and credibility with team members, stakeholders, and leadership, leading through natural authority, scientific credibility, sound judgment, and influence rather than hierarchy. Leverage that trust and influence to align priorities, resources, and timelines across functions, navigate ambiguity, resolve issues, foster open dialogue, and build alignment around decisions that successfully advance the asset.
• Shape and strengthen team culture by promoting scientific excellence, inclusion, collaboration, candid dialogue, entrepreneurial thinking, accountability, and a strong sense of shared ownership for the success of the asset and broader portfolio.
• Lead a portfolio of programs across multiple modalities, which may include small molecules, biologics, antibody-drug conjugates, cell and gene therapies, toxins, devices, and implants. Program assignments will consider the CMC PDD’s experience and qualifications to set them up for success, while providing opportunities to broaden their experience, build new capabilities, and grow in the role.

Qualifications

Required Qualifications:

• Bachelor’s degree with at least 12 years of relevant industry experience; Master’s degree with at least 10 years; or PhD with at least 8 years of relevant experience. At least 3 years of experience required in the role of CMC team leader or in relevant role in related CMC function.
• Significant experience in pharmaceutical development, with strong interdisciplinary CMC expertise and an understanding of drug development, global regulatory and quality requirements, and CMC strategies across development stages.
• Demonstrated ability to lead and influence highly matrixed, cross-functional teams, build alignment without relying on formal authority, and establish trust and credibility with team members, stakeholders, and senior leaders.
• Excellent written and verbal communication skills, with the ability to translate complex scientific and technical information into clear strategic choices and recommendations for diverse audiences.
• Strong leadership, interpersonal, negotiation, and influencing skills, combined with sound scientific and business judgment and the ability to make timely decisions.
• Demonstrated strategic thinking, adaptability, learning agility, and ability to navigate ambiguity, with the curiosity and willingness to expand into new scientific areas, technologies, and modalities.

Preferred Qualifications:

• Experience developing biologics and/or other complex modalities, including antibody-drug conjugates, cell and gene therapies, combination or device products.
• Experience with strategic collaborations, due diligence, external innovation, or integrating externally developed assets or technologies into an internal development pipeline.
• Demonstrated ability and interest in learning new modalities and scientific areas, applying existing CMC and development expertise to new technologies and increasingly complex programs.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law:

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemayultimatelypaymore or less than the posted range. This range may bemodifiedin thefuture.

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.

• This job is eligible toparticipatein our long-term incentiveprograms.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremainsin the Company's sole andabsolutediscretion unless and until paid andmay bemodifiedat the Company’s sole and absolute discretion, consistent withapplicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

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