MSAT Process Lead

Role Summary

Provide technical leadership within Manufacturing Science and Technology by defining and maintaining the processes as part of Tech transfer / NPI activities such as:

• ICH‑Q3 risk assessments and testing strategies
• Establishment of an end‑to‑end process for materials management (raw materials, process consumables, single‑use components).
• Translate GMP and regulatory expectations into robust risk management strategies, ensuring compliance and reliable manufacturing & supply.

Your mission

Key Responsibilities

Lead and author ICH Q3 risk assessments:

• Perform risk identification, quantification, and control strategy definition for process‑related impurities derived from materials of construction of product contact materials.
• Define and justify risk monitoring testing strategies using ICH Q9 principles and product knowledge.

Lead process materials manageme...