MSAT Process Lead

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 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.

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 <665>/<1663>/<1664>) 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