QC Validation Specialist
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:
- Lead and support the development, validation and technology transfer of new and established analytical methods for gene therapy products.
- Design validation studies and generate validation protocols, data analysis summaries and comprehensive reports.
- 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).
- Create, update and maintain method SOPs and technical documentation.
- Provide clear communication and progress updates to cross-functional stakeholders.
- Conduct routine assessments of analytical methods to ensure continued control and suitability.
- Support Quality Management System activities, including document control and data integrity oversight.
- Maintain and track personal training, GMP compliance and document lifecycle responsibilities (deviations, CAPAs, change controls).
- When required, perform analytical testing of gene therapy products according to approved specifications.
- A degree or Master’s in a scientific discipline (e.g., Biology, Biotechnology, Biochemistry).
- Approx. 2+ years’ experience in the pharmaceutical, biologics, or a similarly regulated environment.
- Demonstrated experience in method validation, including:
- Designing validation studies,
- Writing and reviewing protocols and validation reports,
- A strong understanding of regulatory requirements and data integrity.
- Experience with analytical techniques (advantageous but not essential): qPCR, HPLC (RP-HPLC/SEC), ELISA, SDS-PAGE/Western blot, cell culture, DNA extraction.
- Strong understanding of ICH Q2(R1).
- Proficiency in Microsoft Office (Word, Excel, PowerPoint).
Keywords: QC Validation Chemist, Method Transfer Chemist, Analytical Chemist, Scientist, Chemist, Analytical Chemist, Scientist,Chemist, HPLC,GMP