Job Description
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...