Seeking a QC Validation Specialist!
This position plays a critical role in ensuring analytical methods are properly designed, validated and transferred in alignment with EU/FDA GMP requirements for advanced therapy products.
We are particularly interested in speaking with candidates who have hands-on experience designing validation studies, as well as authoring and reviewing validation protocols and reports —not just executing test methods developed by others. A genuine understanding of the regulatory landscape and the rationale behind validation activities is essential.
The Role
In this position, you will:
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Lead and support the development, validation and technology transfer of new and established analytical methods for gene therapy products.
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Design validation studies and generate validation protocols, data analysis summaries and comprehensive reports.
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Ensure analytical methods are fully validated and transferred into QC GMP laboratories in line with regulatory expectations (EU/FDA, ICH Q2(R1), GMP, data integrity).
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Create, update and maintain method SOPs and technical documentation.
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Provide clear communication and progress updates to cross-functional stakeholders.
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Conduct routine assessments of analytical methods to ensure continued control and suitability.
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Support Quality Management System activities, including document control and data integrity oversight.
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Maintain and track personal training, GMP compliance and document lifecycle responsibilities (deviations, CAPAs, change controls).
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When required, perform analytical testing of gene therapy products according to approved specifications.
Candidate Profile
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A degree or Master’s in a scientific discipline (e.g., Biology, Biotechnology, Biochemistry).
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Approx. 2+ years’ experience in the pharmaceutical, biologics, or a similarly regulated environment.
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Demonstrated experience in method validation, including:
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Designing validation studies,
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Writing and reviewing protocols and validation reports,
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A strong understanding of regulatory requirements and data integrity.
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Experience with analytical techniques (advantageous but not essential): qPCR, HPLC (RP-HPLC/SEC), ELISA, SDS-PAGE/Western blot, cell culture, DNA extraction.
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Strong understanding of ICH Q2(R1).
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Proficiency in Microsoft Office (Word, Excel, PowerPoint).
Keywords: QC Validation Chemist, Method Transfer Chemist, Analytical Chemist, Scientist, Chemist, Analytical Chemist, Scientist,Chemist, HPLC,GMP
