Job DescriptionAbbVie 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 AbbVie'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 AbbVie 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 AbbVie 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, escalate, 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 AbbVie 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.
Qualifications- 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 transfer, and lifecycle management.
- Strong understanding of CMC regulatory expectations, quality systems, and process safety.
- Demonstrated success managing multiple projects, priorities, and external partners in a fast-moving environment.
- Excellent program management skills with a strong sense of ownership and accountability.
- Proven ability to influence without authority and collaborate effectively across scientific, operational, and leadership teams.
- Recognized technical expert and strategic thinker with the ability to guide complex external manufacturing decisions.
- Experience with digital transformation, automation, and operational excellence initiatives is highly desirable.
- Willingness and ability to travel domestically and internationally up to 25%.
Additional InformationApplicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of thisposting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location,and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our long-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission,incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless anduntil paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.
