Our offer
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 profile
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; ability to communicate complex rationales to regulators and auditors.
* Bilingual French, English
Working conditions
* On‑site or hybrid; ability to spend time in development and manufacturing areas as needed with PPE and cleanroom gowning as required.
* Occasional travel to suppliers/CMOs and/or supporting on‑site audits (up to ~10%).
Contact
If 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 rh@baccinex.com
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 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 impurity‑related deviations, root cause analyses, and CAPAs.
* Trend process related impurities and selected material quality attributes; build predictive monitoring and alert limits for APIs and critical process materials.
* New product introductions and tech transfer: Assess site start‑up readiness and timelines with respect to new process materials.
Provide support in defining and maintaining MSAT processes as part of tech‑transfer activities:
* Maintain procedures, templates and forms
* Ensure standardization and efficiency across processes
* Collect feedback from program managers and subject matter experts to improve and simplify the processes
Regulatory and quality interfaces:
* Support internal/external audits and regulatory authority inspections; present risk assessments, process impurities control strategies, and evidence of effectiveness.
Cross‑functional leadership:
* Collaborate and find opportunities to harmonize approaches, create synergies and contribute to the development of Raw Materials Center of Excellence.
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