AbbVie
Associate Director, Process Chemistry (External Manufacturing)
North Chicago, IL, United States · Director
Sponsorship not specifiedDetected 1 day ago
Supply ChainGMPAnimal StudiesLeadershipDemand Planning
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Cap-exempt (no lottery)0
Sponsors this role85
Entry-level history0
PERM / green-card track0
Lottery odds40
Fits your clock70
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About the role
- For more information about AbbVie, please visit us at www.abbvie.com.
- Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
- AbbVie is seeking a highly experienced and strategic Associate Director I, Process Development (External Manufacturing) to join our Synthetic Molecule (SM) CMC organization.
Responsibilities
- Lead SCPS responsibilities across multiple AbbVie programs and mentor API teams and PPDST members in developing robust external manufacturing strategies for SM, t-LNPs, peptides, and ADC clinical assets.
- Own CMC timelines, drug substance supply/demand planning, and budgetary oversight, including proactive phase-gate management of external spend and alignment with SM CMC leadership on at-risk spend.
- Develop and maintain cost of goods estimates to support R&D and clinical development decisions.
- Identify, escalate, and communicate critical supply chain issues at the program level, partnering with appropriate subject matter experts to develop and execute mitigation plans.
- Build, coach, and retain high-performing talent with strong capabilities in outsourcing, external manufacturing, and matrix teamwork.
- Drive cross-functional improvements in workflows, CRO/CDMO management practices, in-licensing readiness, and CMC development execution.
- Partner closely with Purchasing, Finance, Regulatory, and Quality to ensure all CRO/CDMO activities meet AbbVie requirements for quality, finance, ethics, and compliance.
- Support TQA and MSA activities as needed to enable effective external partnerships.
- Drive supplier diversification while actively managing strategic CRO/CDMO relationships.
- Lead due diligence and onboarding CMC activities for in-licensed assets, including gap assessment and DS/DP supply chain mitigation planning.
Requirements
- Strong understanding of CMC regulatory expectations, quality systems, and process safety.
- Experience with digital transformation, automation, and operational excellence initiatives is highly desirable.
Company info
- 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.
Equal opportunity
- Employer/Veterans/Disabled.
- US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
- US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
- https://www.abbvie.com/join-us/reasonable-accommodations.html
This listing is sourced directly from AbbVie's careers page and normalized into a canonical job model.