Fellow MSAT Nitrosamine & Impurity Lead

Johnson & Johnson Co.; Schaffhausen; On-site; CHF 180,000 - 240,000; Full time

Job summary

Johnson & Johnson is seeking a Fellow, MSAT Synthetics Nitrosamines and Impurity Management in Schaffhausen, Switzerland. The role ensures a robust impurity strategy across commercial synthetic products, providing technical depth and cross-functional mentorship from development to manufacturing and lifecycle.

You will influence process architecture, regulatory commitments, and impurity control strategies. The position emphasizes leadership in Nitrosamines and broader impurities, collaboration

Qualifications

• Advanced leadership in impurity management and regulatory controls.
• Experience with ICH impurity guidelines and drug substance/product interfaces.
• Strong collaboration across R&D, manufacturing, QA, and regulatory.
• Proven ability to manage technical reviews and lifecycle changes.

Responsibilities

• Provide expert leadership in impurity management for the Synthetics portfolio.
• Drive risk assessments and regulatory controls for impurities across DS/DP.
• Mentor and collaborate with cross-functional teams and sites.
• Support inspections and lifecycle changes with regulatory justifications.

Skills

Agile

Compliance

Consulting

Crisis management

Design mindset

Emerging tech

Lean SCM

Program mgmt

Project scheduling

STEM

Technical credibility

Technical research

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at jnj.com. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function: Supply Chain Engineering Job Sub Function: Process Engineering Job Category: Scientific/Technology All Job Posting Locations: Schaffhausen, Switzerland

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

Required Skills: Preferred Skills: Agile Decision Making, Compliance Management, Consulting, Crisis Management, Design Mindset, Disruptive Innovations, Emerging Technologies, Lean Supply Chain Management, Managing Blended Teams, Operational Excellence, Process Control, Process Engineering, Product Costing, Program Management, Project Schedule, Science, Technology, Engineering, and Math (STEM) Application, Technical Credibility, Technical Research

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact, to humanity.Learn more at https://www.jnj.com/.

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