Director, Late-Stage CMC Product Development

AbbVie Inc.; North Chicago (IL); On-site; USD 161,000 - 305,000; Full time

Benefits offered by this job

Long-term incentive programs

Benefits package including paid time 0

Job summary

AbbVie Inc. is seeking a Director, CMC Product Development - Late Stage, Operations to lead the CMC development plan for late-stage assets.

You will collaborate with clinical, regulatory and commercial teams to ensure robust CMC strategies across modalities, including small molecules and biologics, and align with asset strategies. The role requires strong leadership, strategic thinking, and proven experience in guiding crossfunctional teams through regulatory submissions and global filings, with

Qualifications

• Bachelor’s Degree with at least 18 years of experience in CMC functions required; Master’s Degree with at least 16 years of relevant CMC experience required; or PhD with at least 10 years of relevant CMC experience required to effectively manage global teams and all CMC activities with respect to science, technology, quality, regulatory/compliance requirements, budget and resources.
• Multiple product development experiences of leading a CMC team through regulatory submissions (NDA/BLA/PMA/510K preferred).
• Must possess good scientific writing skills and good verbal skills.
• Must have a good working knowledge of regulatory requirements and familiarity with relevant CMC development approaches. (Device regulatory requirements preferred.)
• Knowledge of pharmaceutical sciences and the drug/device development process.
• Must have CMC interdisciplinary experience and expertise.
• Possess negotiating, influencing and leadership skills. Creative in implementing entrepreneurial thinking and capable of making smart business decisions.

Responsibilities

• Represents all CMC areas on the AST serving as spokesperson for the CMC project team and ensures information flow among the AST and all line functions. Ensures high quality science, technology, deliverables, and collaborates to ensure compliance with global regulatory and quality requirements. Participates in interactions with Regulatory and Health Authorities.
• Critically evaluates and integrates drug substance, drug product, and device inputs to CMC team strategies and plans that align with corporate business objectives. Decision-making will often require assessment and integration of physical chemical properties, formulation science, engineering, analytical, and device technical information in conjunction with the project strategy, with full consideration of current regulatory and compliance requirements.
• Manages multiple projects and contributes to project prioritization. Negotiates for additional resources when required, influences project timelines to ensure proper completion of required activities. Implements creative approaches to conserve resources, and achieve efficiency with respect to time, and budget. Provides feedback to CMC management on resource and talent opportunities.
• Reviews contracts with external partners and consultants. Develops a budget in collaboration with AST and obtains resources from functional areas. Accountable for the success and overall CMC quality of a given project. Ensures timely execution of project plan to deliver high quality with respect to science, technology, compliance and cost effectiveness.
• Represents AbbVie on high profile partnerships and collaborations with other pharma/biotech companies and at the Joint Development Committee level driving decisions for the development programs.
• Promotes scientific and entrepreneurial thinking, encourage creativity and manage quality and results with respect to science, time, budget and resources.
• Ensures compliance with regulatory, health, safety and environmental requirements. Stay abreast of developments in global technical, regulatory and compliance arena and industry practice.
• Apprises CMC Management of plans and risks through regular communications and periodic reviews throughout development and in support of global filings, approvals and launches.
• Ensures high level of morale in the CMC team.

Job description

AbbVie Inc. is seeking a Director, CMC Product Development - Late Stage, Operations to lead the CMC development plan for late-stage assets.

You will collaborate with clinical, regulatory and commercial teams to ensure robust CMC strategies across modalities, including small molecules and biologics, and align with asset strategies. The role requires strong leadership, strategic thinking, and proven experience in guiding crossfunctional teams through regulatory submissions and global filings, with