Ph3Our offer /h3 pbRole summary /b /p ul liProvide technical leadership within Manufacturing Science and Technology by defining and maintaining the processes as part of Tech transfer / NPI activities such as, /li liICH-Q3 risk assessments and testing strategies /li liEstablishment of an end‑to‑end process for materials management (raw materials, process consumables, single‑use components). /li liTranslate GMP and regulatory expectations into robust risk management strategies, ensuring compliance and reliable manufacturing supply. /li /ul h3Your profile /h3 pbMinimum qualifications, skills and competencies /b /p ul liMS in Chemical Engineering, Chemistry, Pharmaceutical Sciences, or related field. /li li5+ years (Scientist/Engineer) in MSAT, Process Development, Quality, or related GMP manufacturing role in pharma/biotech. /li liHands‑on experience performing and defending drug product risk assessments (e.g. ICH Q3C and Q3D assessments) /li liDemonstrated knowledge of raw material/process material qualification and specification setting in a GMP environment. /li liStrong knowledge of cGMPs and ICH guidelines (Q3 series, Q7, Q8, Q9, Q10; for biologics also Q11), BPOG, USP 665/1663/1664 and materials of construction. /li liExperience with supplier technical management and dual‑source/alternate material qualification. /li liClear technical writing and presentation skills; ability to communicate complex rationales to regulators and auditors. /li liBilingual French, English /li /ul bWorking conditions /b ul liOn‑site or hybrid; ability to spend time in development and manufacturing areas as needed with PPE and cleanroom gowning as required. /li liOccasional travel to suppliers/CMOs and/or supporting on‑site audits (up to ~10%). /li /ul h3Contact /h3 pIf you are ready to actively contribute and join a dynamic sector, please submit your CV via our online form along with a cover letter highlighting your relevant experience and explaining why you are interested in this position. In case of questions, please reach out to /p h3Your mission /h3 pbKey responsibilities /bbr/Lead and author ICH Q3 risk assessments: /p ul liPerform risk identification, quantification, and control strategy definition for process‑related impurities derived from materials of construction of product contact materials. /li liDefine and justify risk monitoring testing strategies using ICH Q9 principles and product knowledge. /li /ul pLead process materials management: /p ul liOwn the lifecycle of process materials from specification through qualification, use, and change control. /li liEstablish material requirements and critical attributes; create critical materials qualification protocols and reports i.e for single use systems (SUS). /li liImplement whenever necessary dual sourcing or alternate materials, and identify obsolescence risks /li /ul pTechnical stewardship and investigations: /p ul liLead material‑or impurity‑related deviations, root cause analyses, and CAPAs. /li liTrend process related impurities and selected material quality attributes; build predictive monitoring and alert limits for APIs and critical process materials. /li liNew product introductions and tech transfer: Assess site start‑up readiness and timelines with respect to new process materials. /li /ul pProvide support in defining and maintaining MSAT processes as part of tech‑transfer activities: /p ul liMaintain procedures, templates and forms /li liEnsure standardization and efficiency across processes /li liCollect feedback from program managers and subject matter experts to improve and simplify the processes /li /ul pRegulatory and quality interfaces: /p ul liSupport internal/external audits and regulatory authority inspections; present risk assessments, process impurities control strategies, and evidence of effectiveness. /li /ul pCross‑functional leadership: /p ul liCollaborate and find opportunities to harmonize approaches, create synergies and contribute to the development of Raw Materials Center of Excellence. /li /ul /p #J-18808-Ljbffr