Director, CMC Strategy & Cross-Functional Leadership

AbbVie; Waltham (MA); On-site; USD 190,000 - 270,000; Full time

Benefits offered by this job

Medical/dental/vision insurance

401(k) plan

Paid time off

Job summary

AbbVie is seeking a Senior CMC Leader to drive cross‑functional product development from IND through NDA/MAA, coordinating technical ownership across CMC and S&T teams. The role interfaces with R&D, RA, MES, QA, and supply chain to advance development milestones.

Responsibilities include shaping project plans, budgets, and timelines, plus review of submissions and lifecycle management. This is a high‑impact, on‑site leadership position based in the US.

Qualifications

• CMC development experience through IND and NDA/MAA preferred.
• Experience leading multiple CMC project teams.
• Knowledge of FDA/global regulatory requirements for CMC.

Responsibilities

• Lead cross-functional S&T product teams and interface with leadership.
• Develop and maintain project plans, budgets, timelines, strategies.
• Own product/process/methods tech ownership within CMC.
• Review regulatory submissions and post‑approval life cycle.

Skills

CMC leadership

Regulatory knowledge

Project management

Technical writing

Education

Bachelor’s degree + 16+ years (CMC)

Master’s degree + 14+ years (CMC)

PhD + 12+ years (CMC)

Job description

AbbVie is seeking a Senior CMC Leader to drive cross‑functional product development from IND through NDA/MAA, coordinating technical ownership across CMC and S&T teams. The role interfaces with R&D, RA, MES, QA, and supply chain to advance development milestones.

Responsibilities include shaping project plans, budgets, and timelines, plus review of submissions and lifecycle management. This is a high‑impact, on‑site leadership position based in the US.