Director, CMC Product Development at AbbVie · LumiJobs

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.

Qualification

Strong leadershipDemonstrated strategic thinking

Required

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

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.
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.

Director, CMC Product Development

Responsibilities

Qualification

Required

Preferred

Benefits

Company

AbbVie

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