Associate Director, Process Chemistry (External Manufacturing
Listed on 2026-08-02
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Business
Regulatory Compliance Specialist
Company Description
About Abb Vie
Abb Vie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. 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. For more information about Abb Vie, please visit us at Follow @abbvie on Linked In, Facebook, Instagram, X and You Tube.
Job DescriptionAbb Vie is seeking a highly experienced and strategic Associate Director I, Process Development (External Manufacturing) to join our Synthetic Molecule (SM) CMC organization. In this role, you will lead and support the development and external manufacturing strategy for Abb Vie’s small molecules (SM), t-LNPs, peptides, and ADC clinical assets across a global network of CROs and CDMOs.
This role is ideal for a seasoned process chemistry leader who thrives in a fast-paced, matrixed environment and can successfully manage multiple projects simultaneously. You will serve as a trusted scientific and operational partner, influencing cross-functional teams, guiding external partners, and ensuring reliable, high-quality, and cost-effective supply for preclinical through cPOC programs. You will also play a critical role in CMC planning, budget stewardship, phase-gate governance, and supplier relationship management.
The successful candidate will bring deep expertise in early- and mid-stage process development, strong technical judgment, and the ability to lead with both scientific credibility and operational discipline. This is a high-visibility role representing Abb Vie in strategic partnerships and in-licensing activities, with meaningful impact on development timelines, external manufacturing performance, and overall portfolio success.
Key Responsibilities- Lead SCPS responsibilities across multiple Abb Vie programs and mentor API teams and PPDST members in developing robust external manufacturing strategies for SM, t-LNPs, peptides, and ADC clinical assets.
- Serve as the process chemistry subject matter expert for external CROs/CDMOs and provide technical guidance on process development, scale-up, and lifecycle planning.
- 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, escalce, and communicate critical supply chain issues at the program level, partnering with appropriate subject matter experts to develop and execute mitigation plans.
- Influence cross-functional decisions in a matrix organization, balancing asset team priorities, functional requirements, and business objectives.
- 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 Abb Vie requirements for quality, finance, ethics, and compliance.
- Support TQA and MSA activities as needed to enable effective external partnerships.
- Strengthen leadership capability across the organization to address complex outsourcing challenges and improve decision-making.
- 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.
- Support development and manufacturing activities across global CROs/CDMOs and participate in meetings across multiple international time zones as needed.
- PhD in Process Chemistry with 8+ years of relevant pharmaceutical/biotech industry experience, or MS with 10+ years of relevant experience.
- Extensive experience in small molecule process development, cGMP manufacturing, tech…
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