Scope of Role
* 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.
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 management: Own the lifecycle of process materials from specification through qualification, use, and change control.
* Establish material requirements and critical attributes; create critical materials qualification protocols and reports i.e for single use systems (SUS).
* Implement whenever necessary dual sourcing or alternate materials, and identify obsolescence risks.
* Technical stewardship and investigations: Lead material- or process related impurities deviations, root cause analyses, and CAPAs.
* New product introductions and tech transfer: Assess site start-up readiness and timelines with respect to new process materials.
Minimum Qualifications, Skills and Competencies
* MS in Chemical Engineering, Chemistry, Pharmaceutical Sciences, or related field.
* 5+ years (Scientist/Engineer) in MSAT, Process Development, Quality, or related GMP manufacturing role in pharma/biotech.
* Hands‑on experience performing and defending drug product risk assessments (e.g. ICH Q3C and Q3D assessments).
* Demonstrated knowledge of raw material/process material qualification and specification setting in a GMP environment.
* Strong knowledge of cGMPs and ICH guidelines (Q3 series, Q7, Q8, Q9, Q10; for biologics also Q11), BPOG, USP / / ) and materials of construction.
* Experience with supplier technical management and dual-source/alternate material qualification.
* Clear technical writing and presentation skills.
* English C1 level and preferably understands and speaks French.
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