Associate Director / Director, CMC Product Development
AbbVie
August 23, 2026
Remote friendly (North Chicago, IL)
United States
$160,500 - $305,000 USD yearly
Operations
Description:
Independently manages several clinical development programs of higher complexity using a matrix approach. Leads CMC teams and Product Presentation and Device Strategy Teams (PPDST) of functional representatives for projects with external collaboration partners. As PPDST co-chair for Asset Strategy Teams (ASTs) and key member of AST, creates a CMC strategy and development plan aligned to asset strategy, serving as spokesperson for CMC functions and ensuring information flow among AST, line functions, and stakeholders. Partners with Clinical, Regulatory, Operations, Quality, Preclinical Safety, ADME, and Commercial; communicates CMC plans, strategies, and risks for global filings and approvals. Supports corporate/division initiatives and influences CMC technical initiatives. Scope: late-discovery through tech transfer to commercial manufacturing.
Responsibilities:
- Represent all CMC areas on AST; ensure high-quality deliverables and compliance; respond to regulatory queries; own CMC development plan (timelines, risks, mitigations).
- Lead PPDST/CMC development teams; schedule meetings, set agendas, drive risk mitigation, and run periodic phase transition reviews.
- Review third-party manufacturer/consultant contracts; develop budget needs; drive outsourcing/legal/financial aspects; negotiate and influence.
- Lead due diligence for in-licensing and transition leadership when development is internalized.
- Manage complex programs; negotiate resources; manage timelines, efficiency, and feedback to functional managers; mentor 0–3 direct reports.
- Ensure alignment with preclinical toxicology/biological sciences and QTAS/ADME; integrate preclinical development plans.
- Ensure regulatory, health, safety, and environmental compliance; manage dossier quality and global agency communications.
Qualifications:
Director: BS 12+ years (or MS 10+, or PhD 8+); 3–8 years in same/similar CMC role.
Associate Director: BS 10+ years (or MS 8+, or PhD 6+); 2–6 years in same/similar role.
Required skills: excellent scientific writing/verbal communication; regulatory knowledge and familiarity with scientific instrumentation; deep/solid understanding of pharmaceutical drug development; CMC interdisciplinary expertise; negotiating/influencing/leadership; entrepreneurial, creative business decision-making; cross-functional collaboration.
Benefits (as stated): paid time off; medical/dental/vision insurance; 401(k) (eligible employees); eligible for long-term incentive programs.
Independently manages several clinical development programs of higher complexity using a matrix approach. Leads CMC teams and Product Presentation and Device Strategy Teams (PPDST) of functional representatives for projects with external collaboration partners. As PPDST co-chair for Asset Strategy Teams (ASTs) and key member of AST, creates a CMC strategy and development plan aligned to asset strategy, serving as spokesperson for CMC functions and ensuring information flow among AST, line functions, and stakeholders. Partners with Clinical, Regulatory, Operations, Quality, Preclinical Safety, ADME, and Commercial; communicates CMC plans, strategies, and risks for global filings and approvals. Supports corporate/division initiatives and influences CMC technical initiatives. Scope: late-discovery through tech transfer to commercial manufacturing.
Responsibilities:
- Represent all CMC areas on AST; ensure high-quality deliverables and compliance; respond to regulatory queries; own CMC development plan (timelines, risks, mitigations).
- Lead PPDST/CMC development teams; schedule meetings, set agendas, drive risk mitigation, and run periodic phase transition reviews.
- Review third-party manufacturer/consultant contracts; develop budget needs; drive outsourcing/legal/financial aspects; negotiate and influence.
- Lead due diligence for in-licensing and transition leadership when development is internalized.
- Manage complex programs; negotiate resources; manage timelines, efficiency, and feedback to functional managers; mentor 0–3 direct reports.
- Ensure alignment with preclinical toxicology/biological sciences and QTAS/ADME; integrate preclinical development plans.
- Ensure regulatory, health, safety, and environmental compliance; manage dossier quality and global agency communications.
Qualifications:
Director: BS 12+ years (or MS 10+, or PhD 8+); 3–8 years in same/similar CMC role.
Associate Director: BS 10+ years (or MS 8+, or PhD 6+); 2–6 years in same/similar role.
Required skills: excellent scientific writing/verbal communication; regulatory knowledge and familiarity with scientific instrumentation; deep/solid understanding of pharmaceutical drug development; CMC interdisciplinary expertise; negotiating/influencing/leadership; entrepreneurial, creative business decision-making; cross-functional collaboration.
Benefits (as stated): paid time off; medical/dental/vision insurance; 401(k) (eligible employees); eligible for long-term incentive programs.