Associate Director, Process Chemistry (External Manufacturing)
AbbVie
August 21, 2026
Remote friendly (North Chicago, IL)
United States
$141,500 - $268,500 USD yearly
Operations
Associate Director I, Process Development (External Manufacturing)
Key Responsibilities:
- Lead SCPS responsibilities across multiple programs; mentor API teams and PPDST members to develop external manufacturing strategies for SM, t-LNPs, peptides, and ADC clinical assets.
- Serve as process chemistry SME for external CROs/CDMOs; provide technical guidance on process development, scale-up, and lifecycle planning.
- Own CMC timelines, DS supply/demand planning, and budgetary oversight, including phase-gate management of external spend and alignment on at-risk spend.
- Develop and maintain cost of goods estimates for R&D and clinical decisions.
- Identify/escalate critical supply chain issues and execute mitigation plans.
- Influence cross-functional decisions in a matrix organization.
- Build, coach, and retain talent for outsourcing/external manufacturing.
- Drive cross-functional workflow and CRO/CDMO management improvements; support in-licensing readiness and CMC execution.
- Partner with Purchasing, Finance, Regulatory, and Quality to meet quality, finance, ethics, and compliance requirements.
- Support TQA and MSA activities; strengthen leadership for complex outsourcing challenges.
- Drive supplier diversification and manage strategic CRO/CDMO relationships.
- Lead due diligence and onboarding CMC activities for in-licensed assets.
- Support global CRO/CDMO development/manufacturing activities and attend meetings across international time zones as needed.
Qualifications:
- PhD in Process Chemistry with 8+ years relevant industry experience, or MS with 10+ years.
- Experience in small molecule process development, cGMP manufacturing, tech transfer, and lifecycle management.
- Knowledge of CMC regulatory expectations, quality systems, and process safety.
- Proven ability to manage multiple projects and external partners.
- Strong program management, ownership, and ability to influence without authority.
- Recognized technical expert and strategic thinker.
- Digital transformation/automation/operational excellence experience (highly desirable).
- Travel up to 25% (domestic and international).
Benefits:
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) for eligible employees.
- Eligible for long-term incentive programs.
Application instructions:
- Not provided in the job description text.
Key Responsibilities:
- Lead SCPS responsibilities across multiple programs; mentor API teams and PPDST members to develop external manufacturing strategies for SM, t-LNPs, peptides, and ADC clinical assets.
- Serve as process chemistry SME for external CROs/CDMOs; provide technical guidance on process development, scale-up, and lifecycle planning.
- Own CMC timelines, DS supply/demand planning, and budgetary oversight, including phase-gate management of external spend and alignment on at-risk spend.
- Develop and maintain cost of goods estimates for R&D and clinical decisions.
- Identify/escalate critical supply chain issues and execute mitigation plans.
- Influence cross-functional decisions in a matrix organization.
- Build, coach, and retain talent for outsourcing/external manufacturing.
- Drive cross-functional workflow and CRO/CDMO management improvements; support in-licensing readiness and CMC execution.
- Partner with Purchasing, Finance, Regulatory, and Quality to meet quality, finance, ethics, and compliance requirements.
- Support TQA and MSA activities; strengthen leadership for complex outsourcing challenges.
- Drive supplier diversification and manage strategic CRO/CDMO relationships.
- Lead due diligence and onboarding CMC activities for in-licensed assets.
- Support global CRO/CDMO development/manufacturing activities and attend meetings across international time zones as needed.
Qualifications:
- PhD in Process Chemistry with 8+ years relevant industry experience, or MS with 10+ years.
- Experience in small molecule process development, cGMP manufacturing, tech transfer, and lifecycle management.
- Knowledge of CMC regulatory expectations, quality systems, and process safety.
- Proven ability to manage multiple projects and external partners.
- Strong program management, ownership, and ability to influence without authority.
- Recognized technical expert and strategic thinker.
- Digital transformation/automation/operational excellence experience (highly desirable).
- Travel up to 25% (domestic and international).
Benefits:
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) for eligible employees.
- Eligible for long-term incentive programs.
Application instructions:
- Not provided in the job description text.