Fellow MSAT Nitrosamine & Impurity Lead

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Job Description:

The Fellow, MSAT Synthetics Nitrosamines and Impurity Management is a scientific authority ensuring a robust strategy on Impurities potentially present in synthetic drug products, with a primary focus on the Nitrosamine Risk Assessment Strategy across the commercial synthetic portfolio.

The role provides technical and scientific continuity from late development through commercial manufacturing and across the commercial product lifecycle, ensuring that scientific intent, process architecture and regulatory commitments translate into resilient and supply‑reliable commercial execution and impurity control strategy.

Operating as an individual contributor, the Fellow influences through technical depth, platform and systems thinking, and mentorship.

Key Responsibilities:

1.                Technical leadership

• Provide expert leadership in Impurity Management across the Synthetics portfolio.
• Drives risk assessments and regulatory controls for Impurities across Drug Substance and Drug Product. Deep knowledge of ICH Guidelines on Impurity Management.
• Initially focuses on Nitrosamines, later expert leadership on Impurities such as PFAS as well as Extractables & Leachables management across the commercial synthetic portfolio.
• Interacts with manufacturing and synthesis chemists as well as with formulation scientists and packaging engineers to optimize reaction parameters and/or adjust pharmaceutical compositions/packaging in view of Impurity Management.
• Interacts with analytical and safety experts in relation to control strategy development
• Serve as the global subject matter expert on degradation pathways, extractables/leachables, and impurity profiling
• Strengthen JJIM’s Impurity Management via intellectual property and scientific communications.

2.                Portfolio & Stakeholder management

• Serve as trusted Synthetics DP technology advisor on MSAT Synthetics Technical Review Committee (TRC), partner closely with management and SME’s across Synthetics Development (pharmaceutical, chemical and analytical development), Toxicology, MSAT SM DS and DP, Global Engineering, Quality, Regulatory Affairs, Value Chain Management, and Supply Chain.
• Strongly link to Manufacturing Sites and Cleaning CoP/Fellow on the Impurity Management and Cleaning Validation Strategies (Impurity Carry-over).
• Ensure alignment between product portfolio needs, site capabilities, and value chain expectations.
• Act as a technical representative and innovative leader in relevant industry and regulatory fora.
• Function as mentor to partnering functions

3.                Regulatory & CMC Technical Stewardship

• Serve as a senior technical reviewer and contributor for CMC sections related to Impurity Management and control strategies.
• Support inspections, health authority interactions, and lifecycle changes with clear, scientifically grounded justifications.

4.                Commercialization and Life Cycle Management

• Serve as technical steward for the Impurity Management across the synthetic commercial product portfolio.
• Provide expert input on manufacturing technologies as well as packaging materials for both DS and DP from an Impurity Management point of view.
• Guide BP²AL-targets, driving towards a robust design together with a validated Impurity control strategy.

Provide technical guidance of post‑launch Impurity Management to enable commercial improvements

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