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, production and characterisation of biological raw materials 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, process development and optimisation, raw material production, analytical testing and the preparation of scientific and technical documentation within a regulated pharmaceutical environment.

MISSION

To contribute to the development, optimisation, production and analysis of raw materials for allergen immunotherapy products, ensuring that processes, methodologies and activities comply with the scientific, regulatory and quality standards established by the company.





The position will contribute both to the continuous improvement of existing processes and to the development of new allergen sources and production processes, participating in their experimental evaluation and subsequent implementation within the area.

MAIN TASKS AND RESPONSIBILITIES

- Process Development & Optimisation: Participate in the development, evaluation and optimisation of processes for obtaining and processing biological raw materials, while also contributing to the production of materials using established and validated processes.
- Raw Material & Supplier Evaluation: Participate in the assessment of new suppliers, raw materials and allergen sources, evaluating their suitability from scientific, technical and quality perspectives.
- Pilot Batches & Active Substance: Plan, execute and analyse pilot batches of Active Substance, monitor and assess the results obtained, and prepare the corresponding scientific and technical reports.
- Experimental Design & Scientific Documentation: Design and execute experimental studies related to process development and optimisation, ensuring appropriate documentation of methodologies, results, conclusions and improvement proposals.
- Procedures & Process Documentation: Prepare, review and update experimental protocols, Standard Operating Procedures (SOPs), instructions,



records and other documentation associated with production processes and activities within the area.
- Analytical Method Development & Execution: Participate in the development, optimisation and execution of analytical methodologies for the characterisation and quality control of raw materials, including immunological and biochemical techniques.
- Equipment & Instrumentation: Operate and verify analytical and laboratory equipment, collaborating in calibration, qualification, maintenance and commissioning activities when required.
- Change Control & New Equipment: Participate in Change Control activities and in the preparation of documentation associated with the acquisition and implementation of new equipment, including Risk Assessments and Operating Instructions.
- GMP/GLP & Traceability: Ensure compliance with applicable GMP/GLP requirements and the appropriate traceability, integrity and documentation of processes, tests and activities performed.
- Continuous Improvement: Identify and propose opportunities to improve production processes, analytical methodologies, documentation and working procedures, contributing to the scientific and technical development of the section.
- Cross-functional Collaboration: Work closely with other R&D; scientific and technical teams and collaborate with Quality, Quality Control, Validation and Industrial Operations when required by the nature of the projects.

REQUIREMENTS

Education & Technical Background

- University degree in Biology, Biochemistry, Biotechnology, Pharmacy, Health Sciences or a related scientific discipline.
- Experience in the planning, execution and documentation of experimental studies or research projects.
- Knowl

📌 R&D Raw Materials Section Technician (Zamudio)
🏢 ROXALL Medizin
📍 Zamudio