Projects and QC Support Technician

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 a Projects and QC Support Technician to play a key role within the Quality Control area.

Your mission will be to ensure the coordination, planning and end-to-end of customer projects and batches in the field of Quality Control, ensuring that all activities associated with the manufacture of the batch, from inception to release and stability studies are executed in a timely manner, in accordance with GMP requirements and the commitments made to the customer.  acting as an operational QC reference for the assigned projects.

• from the initial planning phase to the release of the batch and the closure of the associated stability studies.
• Ensure that all Quality Control activities required for each project are planned and executed according to the committed deadlines, identifying risks, dependencies or deviations early.
• Continuously monitor the status of the project, proactively escalating any relevant deviations that may impact deadlines or commitments with the client.
• Coordinate continuously with the Business Development area to ensure alignment in scope, priorities and dates committed to the client from the QC point of view.
• Coordinate closely with the QC Laboratory Managers (Microbiology and General Laboratory) to ensure the correct planning and execution of the analytical activities required for each project.
• Facilitate the prioritization of activities when there are capacity conflicts, in alignment with the Project Coordination Manager QC.
• Ensure that the documentation associated with QC projects is generated, reviewed and delivered in accordance with the established requirements, including: Sampling plans, Manufacturing Formula Review, Analytical Planning, CoA/RoA, Batch Reports, Documentation and monitoring of stability studies
• Verify that documentary deliverables are closed on time, with traceability and current versions, in accordance with applicable GMP procedures.
• Record, communicate, and track incidents, deviations, or changes that may affect the project schedule, proposing corrective actions and escalating when necessary.
• Manage a portfolio of projects per assigned client, ensuring continuity, visibility into project status, and consistency in planning and deliverables.
• Ensure clear and structured communication of the status of projects within QC.

• University degree in Biology, Biotechnology or related disciplines.
• Minimum experience of 3 years in the pharmaceutical industry or life sciences.
• Knowledge and experience working under GMP or GLP regulations.
• Minimum level of English B2 (C1 is an asset).
• Organizational skills, results-oriented and attention to detail.
• Proactivity, teamwork and orientation to continuous improvement.

• 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.