10 oct
|
ROXALL Medizin
|
Madrid
10 oct
ROXALL Medizin
Madrid
ABOUT USWe are dedicated to the research, design, validation, manufacture and distribution ofanti-allergic vaccines within the allergen immunotherapy sector .OurTechnical, 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.Ourvalue proposition for our peopleis 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 JOBWe are looking for anR&D Raw Materials Section Technician (SMP)to join our R&D Department in Zamudio on apermanent contract .The position will be part of a scientific and technical team specialised in the development, production and characterisation ofbiological raw materials used in allergen immunotherapy products, working with different allergen sources, includingHymenoptera 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.MISSIONTo contribute to thedevelopment, 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 RESPONSIBILITIESProcess 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.REQUIREMENTSEducation & Technical BackgroundUniversity degree inBiology, Biochemistry, Biotechnology, Pharmacy, Health Sciencesor a related scientific discipline.Experience in theplanning, execution and documentation of experimental studies or research projects .Knowledge and hands-on experience inimmunological and biochemical techniques, particularlyELISA, SDS-PAGE,
Western Blot and protein quantification methods .Experience working withinGMP and/or GLP regulated environmentsand managing associated scientific and technical documentation.Experience preparing and reviewingStandard Operating Procedures (SOPs), protocols, records and technical reports.Experience in the development, optimisation or transfer of biological or biotechnological processes will be highly valued.Previous experience withproteins, biological products, vaccines, allergens or immunotherapywill be highly valued.Experience with analytical data acquisition, processing or management software will be considered an asset.Skills & LanguagesFluent English, both written and spoken (C1 level).Advanced computer skills and confidence working in digital environments.Strong analytical skills and the ability to critically interpret experimental results.Ability to work autonomously in a structured, organised and rigorous manner.Strong problem-solving skills and a solution-oriented scientific and technical mindset.Ability to work effectively withinmultidisciplinary teams and collaborative environments .Strong commitment to quality, continuous improvement and procedural compliance.A high level ofcorporate competencies, ideally above the organisation's average range, will be particularly valued.REMUNERATION & WHAT WE OFFERCompetitive compensation package based on experience and qualifications.Permanent positionbased in Zamudio.Opportunity to join an R&D team specialised inallergen immunotherapy and biological raw materials .Direct involvement in activities ranging fromexperimental development to the establishment of robust production and analytical processes .Exposure to different allergen sources and biological processes within a regulated pharmaceutical environment.Participation in cross-functional projects and collaboration with scientific, technical and quality teams.Professional development within a growing, science-driven organisation.Collaborative working environment focused oninnovation, quality and continuous improvement .OBSERVATIONSWe are looking for a professional with a strongscientific and experimental mindset, who enjoys hands-on laboratory work while also being able to understand the overall process, document it appropriately and contribute to its continuous improvement.The idóneo candidate will combinetechnical expertise, scientific curiosity and analytical thinkingwith autonomy, rigour and a structured approach to experimental work.We particularly value candidates who are comfortable working at the intersection ofapplied research and a regulated pharmaceutical environment, with the ability to translate experimental results into reproducible, robust and properly documented processes.#J-18808-Ljbffr
📌 R&D Raw Materials Section Technician ( Zamudio ) (Madrid)
🏢 ROXALL Medizin
📍 Madrid