Fellow MSAT Nitrosamine & Impurity Lead

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:
Beerse, Antwerp, Belgium, Latina, Italy

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 m...