Associate Director, MSAT API

About the role

Madrigal seeks an Associate Director to provide site‑facing MSAT leadership and technical oversight for a small‑molecule API CMO. The role ensures performance monitoring, issue resolution, and readiness for tech transfers and lifecycle changes.

Key responsibilities

• Act as the primary technical interface for the assigned CMO, running governance routines and performance monitoring.
• Coordinate technical issue resolution, improvement actions, and produce weekly/monthly governance packs, issue logs, and trackers.
• Lead readiness tracking for transfers and changes, assess impacts on process understanding and control strategy, and align mitigations with CMC and Quality.
• Provide technical input to deviations, investigations, and CAPAs, maintaining inspection‑ready documentation and knowledge repositories.

Required profile

• BS+ in Engineering, Life Sciences or related field.
• 10–12 years of MSAT, process engineering, or CMC API support experience with external site readiness delivery.
• Demonstrated partner‑facing technical leadership and issue management for commercial API manufacturing.
• Experience supporting CMO audits, inspections, and regulatory responses is preferred.

Required skills

• MSAT technical oversight
• Process engineering
• CMC API support
• Technical governance and risk assessment
• Partner‑facing issue triage and resolution