Expert Solid State & Non-Chromatographic Analytical Technologies

Our client, a leading pharmaceutical organization, is seeking an expert to provide comprehensive oversight of non-chromatographic quality control laboratories. This role involves driving analytical excellence, ensuring regulatory compliance for small molecule APIs, and leading strategic improvement initiatives within a global manufacturing environment.

• Provide scientific oversight and coaching to laboratory personnel on technical matters related to non-chromatographic analytical fields.
• Lead complex scientific investigations and cross-functional quality remediation plans, including the development of CAPA strategies.
• Drive systematic changes by creating change controls and facilitating the implementation of new procedures and guidance documents.
• Develop and review GMP procedures and standards to ensure scientific excellence and regulatory compliance in a commercial environment.
• Manage analytical method transfer activities and act as system owner for an extensive laboratory instrument park.
• Monitor laboratory practices to ensure alignment with industry trends, regulatory expectations, and global standards.
• Represent the quality control department during authority inspections and facilitate compendial vigilance for EP, USP, and JP updates.

• You have a Master's degree in Chemistry, Pharmaceutical Sciences, or a related scientific field.
• You bring 5+ years of experience in small-molecule CMC analytical areas, specifically within analytical R&D, MSaT, or industrialization.
• You possess in-depth knowledge of cGMP principles and ICH guidelines including Q1, Q2, Q7, and M7.
• You have advanced scientific expertise in non-chromatographic technologies such as XRPD, laser diffraction, Karl Fischer (KF), IR spectroscopy, and ICP-OES/MS.
• You're experienced in analytical method validation, stability testing, and analytical method transfer processes.
• You bring strong interpersonal skills with the ability to influence and partner across organizational boundaries.
• You are fluent in English with a good understanding of Dutch.

Nice to Haves

• Possession of a PhD in a relevant scientific discipline.
• Experience with chemometrics, PAT, or RTRT methodologies.
• Familiarity with different phases of pharmaceutical development and Quality Risk Management principles.

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