Analytical Methods Validation Coordinator

We are a Contract Development and Manufacturing Organization (CDMO), based in Donostia-San Sebastián, currently undergoing a major growth project. We are driven by an unwavering passion for science and a strong commitment to excellence and people.

Our purpose: to improve people’s lives through groundbreaking advances in biotechnology and gene therapy that help cure rare diseases and cancer.

With a philosophy not just of working together, but growing together, our company culture is built on honesty, excellence, leadership, engagement, ethics, and rigor.

We are a CDMO (Contract Development and Manufacturing Organization), and the trust placed in us by over 50 biotech companies around the world is our greatest endorsement. We develop and manufacture viral vectors (lentiviral), and are among the European leaders operating under EMA and FDA guidelines. The lentiviral vectors produced by VIVEbiotech are used in the treatment of various diseases, including hematologic and solid cancers, as well as rare diseases.

We are looking for you to be part of our Team!

We are looking for an Analytical Method Validation Coordinator to perform this key role in the company.

Your mission will be to coordinate the strategy, planning and execution of the validation, transfer and implementation of analytical methods in the Quality Control laboratory, providing cross-functional technical support to the QC area and acting as a scientific reference to ensure GMP and ICH compliance (including ICH Q2), data integrity and the availability of robust methods suitable for use in routine control and regulatory support.

You will also coordinate technical communication with clients when required, explaining the strategies for validation, transfer and adaptation of analytical methods.

• Coordinate the strategy, planning and execution of the validation and transfer of analytical methods in QC, ensuring compliance with GMP and ICH.
• Plan, prioritize, and coordinate method validation and transfer activities based on operational and regulatory needs.
• Ensure that analytical validations are executed in accordance with approved protocols, defined acceptance criteria, and data integrity principles.
• Coordinate the transfer of methods from Analytical Development to QC, ensuring their correct implementation and suitability for routine use (“fit for purpose”).
• Provide cross-cutting technical support to the QC area in the use of analytical methods, interpretation of results and resolution of incidents.
• Support other areas of QC when required (e.g. microbiology, physico-chemistry or other analytical functions), contributing to the evaluation of results, data analysis, implementation of methods and resolution of technical problems.
• Review and evaluate analytical data derived from validations, transfers, and QC activities when required.
• Perform scientific analysis of results, including evaluation of trends, outliers, and robustness of analytical methods.
• Ensure that the data generated is consistent, traceable and suitable for use in quality control and regulatory documentation.
• Act as a technical reference in analytical research (OOS, OOT, deviations), defining research and data evaluation strategies.
• Support in the execution of laboratory analyses when required, including evaluation of critical results.
• Draft, review, and maintain validation documentation, including associated protocols, reports, and records.
• Ensure document traceability, technical consistency and compliance with regulatory requirements, guaranteeing availability for audits and inspections.
• Coordinate the training of technical staff in validated analytical methods and ensure their technical competence.
• Supervise the management of analytical standards, ensuring their traceability, control and availability.
• Participate as a technical expert in internal, customer and regulatory audits, defending the validation strategy and the adequacy of methods.
• Explain and justify to clients, when required, the strategies for validation, transfer and implementation of analytical methods, as well as their suitability for intended use.
• Identify and propose improvements in analytical methods, processes and technologies, implementing them through the corresponding quality systems.
• Collaborate transversally with QA, Analytical Development, Production and QC, ensuring alignment between development, validation and routine use of methods.

• University degree related to Biology, Biotechnology or others related to clinical, scientific and/or biomedical areas, with a solid background in Molecular Biology.
• Master’s degree related to one of the areas of knowledge described above.
• GMP Training
• Training in Validation of analytical methods (ICH Q2 and ICH Q5 for biological products)
• Knowledge in ATMP is an asset
• Knowledge of Data Integrity is an asset
• You have at least 3 to 5 years of previous experience in validation and transfer of analytical methods
• You have experience in QC Laboratory under GMP regulations, as well as in associated analytical techniques, such as Cytometry, qPCR, etc.
• You have experience in data analysis and scientific interpretation
• Experience in audit support and analytical troubleshooting is an asset
• You have an upper-intermediate level of English
• You demonstrate a high capacity for teamwork and orientation to results.

• You will participate in innovative projects that are constantly updated technologically.
• You will have a competitive salary in line with your profile for this position.
• You will be part of an expert, young, dynamic, innovative and enthusiastic team united by a common purpose, to accompany our clients to advance in the cure of diseases.
• You will enjoy a professional work environment, which is truly distinguished by our humanity and closeness, and where we take care of diversity and inclusion. Diverse points of view, your curiosity, bring diverse capabilities that strengthen our focus and drive our growth.
• We are proud to offer equal opportunities. All individuals receive equal consideration for our open positions, without regard to gender, age, race, religion, identity, sexual orientation, origin, disability, or any other characteristic.