Role Overview
This is a senior specialist QC role focused on solid-state and non-chromatographic analytical technologies in a small-molecule pharmaceutical setting. The position is designed for an expert who can provide scientific oversight, strengthen laboratory compliance, and drive technical improvement across non-chromatographic QC activities.
The role combines hands-on scientific leadership with quality and compliance ownership. It is not a routine analyst position; instead, it requires someone who can guide investigations, improve procedures, support method lifecycle activities, and coach laboratory teams.
Main Responsibilities
* Provide day-to-day technical and scientific support to release and IPC laboratories.
* Lead complex investigations and support CAPA or remediation plans in a cross-functional setting.
* Review, prepare, and improve GMP procedures, guidance documents, and local working practices.
* Drive change controls and ensure implementation of laboratory improvements.
* Support analytical method transfer, lifecycle management, and compendial vigilance activities.
* Coach and train laboratory staff on technical and scientific matters.
* Act as system owner for laboratory instruments and support inspection readiness.
Technical Focus
The technical scope covers non-chromatographic methods such as XRPD, laser diffraction, Karl Fischer, IR, UV, Raman, AAS, and ICP-OES/MS. Experience with PAT, RTRT, chemometrics, and multivariate experimentation is a plus, especially in commercial or late-stage development environments.
The role also requires strong knowledge of cGMP, analytical method validation, stability testing, analytical method transfer, and compendial verification under current regulatory expectations. In addition, the candidate should understand QbD, Quality Risk Management, and lifecycle principles linked to ICH guidance and broader regulatory frameworks.
Key Requirements
* Master’s degree in Chemistry, Pharmaceutical Sciences, or a related scientific discipline; a PhD is preferred.
* Minimum 5 years of experience in small-molecule CMC analytical work, ideally in analytical R&D, MSaT, or industrialization.
* Strong background in pharmaceutical product release, stability testing, method validation, and method transfer.
* Deep understanding of cGMP and relevant ICH guidance, including Q1, Q2, Q3, Q7, Q14, and M7.
* Scientific familiarity with solid-state and non-chromatographic analytical techniques used in API and intermediate analysis.
* Ability to work independently, manage multiple priorities, and collaborate across functions and departments.
* Strong communication, influencing, and presentation skills across different organizational levels.
* Full professional English and a good understanding of Dutch.
Best-Fit Candidate
This role suits a highly experienced analytical scientist who enjoys being the technical reference point for a laboratory area. The best fit is someone with strong GMP discipline, practical problem-solving ability, and confidence in coaching others while driving continuous improvement.
It is particularly suitable for professionals with experience in commercial QC, analytical development, or late-stage small-molecule environments who are ready to take ownership of complex scientific topics and represent the lab in compliance and inspection settings.