Senior MSAT Specialist, Small Molecules

Senior MSAT Specialist, Small Molecules

Lonza

Visp, Switzerland

In this senior MSAT role based in Visp, Switzerland, you will play a key part in safeguarding product quality and patient safety by driving risk‑based impurity compliance for Small Molecules. You will lead impurity risk assessments and shape robust, pragmatic control strategies across the entire product lifecycle, in line with ICH Q3D, ICH Q3C and ICH Q9.

This position offers a high level of visibility and impact at a strategically important manufacturing site. You will work at the interface of MSAT, Compliance and Operations, collaborate closely with cross‑functional teams, influence critical decisions, and actively contribute to establishing sustainable compliance standards within a dynamic GMP environment.

What you will do:

• Lead and execute impurity risk assessments across the product lifecycle, identifying, assessing and documenting risks and mitigation measures;
• Define and document scientifically sound, compliant impurity control strategies, including risk‑based testing concepts, acceptance criteria, sampling approaches and periodic reviews;
• Evaluate manufacturing processes, utilities, equipment contact materials, raw materials, process aids and changes for potential impurity and carryover risks in a GMP environment;
• Act as MSAT subject matter expert for compliance topics in cross‑functional teams, supporting technology transfers, deviations, investigations and change controls;
• Identify compliance gaps and product impact, providing clear recommendations and pragmatic mitigation plans;
• Ensure high‑quality, audit‑ and inspection‑ready documentation for internal governance and regulatory interactions;
• Build strong collaboration with QC, QA, Manufacturing, Procurement, EHS and external partners to ensure robust data packages and sustainable control strategies.

What we are looking for:

• University degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences or a comparable discipline;
• Solid experience in a GMP‑regulated environment, ideally within Small Molecule API or pharmaceutical manufacturing, MSAT, Process Development, QA or QC;
• Strong ability to interpret process and analytical data and identify gaps against quality and compliance standards;
• Excellent technical writing skills, with a focus on clear, concise and inspection‑ready documentation;
• Confident communicator with the ability to align stakeholders and challenge constructively when needed;
• High level of collaboration combined with autonomy, accountability and a pragmatic mindset;
• Fluency in English; German is considered an advantage.