- 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.
MSAT Process Lead
Courroux, Suisse
Full-time
Permanent employee
Our offer
Role summary
Your mission
Key responsibilities
Lead and author ICH Q3 risk assessments:
Cross-functional leadership:
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.
- 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
- 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.
- 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
- 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
- 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
In case of questions, please reach out to rh@baccinex.com