ABOUT US
We are dedicated to the research, design, validation, manufacture and distribution of anti-allergic vaccines within the allergen immunotherapy sector. Our Technical, R&D; and Clinical Trials headquarters are located in Zamudio, which is also currently home to our only manufacturing site. In this context, we have a strong growth outlook for the coming years. Our value proposition for our people is based on:
* PEOPLE-CENTRIC: We put people and their professional development at the centre of what we do.
* SELF-DEMANDING PEOPLE: We encourage individual accountability and high standards in pursuit of shared goals.
* CURIOUS PEOPLE: We learn through innovation and value the experience and knowledge that each person brings to the organisation. ABOUT THE JOB We are looking for an R&D; Raw Materials Section Technician (SMP) to join our R&D; Department in Zamudio on a permanent contract. The position will be part of a scientific and technical team specialised in the development, manufacture, optimisation and characterisation of biological raw materials and active substances used in allergen immunotherapy products, working with different allergen sources, including Hymenoptera venoms, mites, animal epithelia and pollens. The role combines hands-on laboratory work, manufacturing and scale-up of biological processes, pilot batch production, analytical testing and technical documentation within a regulated pharmaceutical environment. MISSION To contribute to the development, optimisation, manufacture and analysis of biological raw materials and active substances for allergen immunotherapy products, ensuring compliance with the scientific, regulatory and quality standards established by the company. The position will actively participate in the manufacture and evaluation of Active Substance pilot batches,



the optimisation and scale-up of production processes, and the continuous improvement of established manufacturing and analytical methodologies. MAIN TASKS AND RESPONSIBILITIES
* Pilot Batch Manufacturing & Active Substance: Plan, manufacture and analyse Active Substance pilot batches, evaluate process performance and analytical results, and prepare the corresponding technical reports.
* Process Development, Optimisation & Scale-up: Participate in the development, optimisation and scale-up of biological manufacturing processes, contributing to the production of raw materials and active substances using established processes.
* Experimental Protocols & Process Documentation: Prepare, review and update experimental protocols, Standard Operating Procedures (SOPs), manufacturing instructions, technical records and other documentation associated with production processes.
* Analytical Testing & Quality Control: Develop, optimise and execute analytical methodologies for the characterisation and quality control of raw materials and Active Substance obtained from pilot batches, including immunological and biochemical techniques.
* Change Control & Process Implementation: Participate in Change Control activities and prepare technical documentation associated with the acquisition, qualification, commissioning and implementation of new equipment and/or manufacturing processes.
* Equipment & Instrumentation:



Operate and verify analytical and laboratory equipment, collaborating in calibration and qualification activities to ensure reliable and reproducible results.
* GMP/GLP Compliance & Traceability: Ensure compliance with applicable GMP/GLP requirements, maintaining accurate documentation, data integrity and full traceability of manufacturing, analytical and laboratory activities.
* Continuous Improvement: Identify and propose opportunities to improve manufacturing processes, analytical methodologies, operational efficiency and working procedures within the section.
* Cross-functional Collaboration: Work closely with other R&D; teams and collaborate with Quality Assurance, Quality Control, Validation and Industrial Operations to support process optimisation, technical problem-solving and the implementation of improvements. REQUIREMENTS Education & Technical Background
* University degree in Biology, Biochemistry, Biotechnology, Pharmacy, Health Sciences or a related scientific discipline.
* Hands-on experience in the manufacture, development and scale-up of biological, biotechnological or pharmaceutical processes.
* Experience in manufacturing activities, pilot batch production and/or process optimisation within laboratory, pilot plant or pharmaceutical manufacturing environments.
* Professional experience working under GMP and/or GLP requirements and managing associated technical and controlled documentation.
* Experience preparing and reviewing Standard Operating Procedures (SOPs), experimental protocols, manufacturing records and technical reports.
* Knowledge and practical experience in immunological and biochemical techniques, particularly ELISA, SDS-PAGE, Western Blot and protein quantification methods.
* Ability to work

📌 R&D Raw Materials Section Technician (País Vasco)
🏢 Roxall Medicina España
📍 País Vasco