R&D Biologics: Pilot & Scale-Up Technician

ROXALL Medicina España; Zamudio; Sur place; EUR 35 000 - 52 000; Plein temps

Avantages offerts par ce poste

Permanent position in Zamudio

R&D in allergen immunotherapy

Professional development opportunities

Résumé du poste

ROXALL Medicina España in Zamudio is seeking an R&D Raw Materials Section Technician (SMP) to join the R&D Department on a permanent contract. You will work on development, manufacture, optimization and qualification of biological raw materials and active substances for allergen immunotherapy, covering pilot batch production, analytical testing and documentation within a regulated pharma setting.

The role combines hands-on laboratory work with manufacturing process scale-up, process

Qualifications

• University degree in Biology, Biochemistry, Biotechnology, Pharmacy, Health Sciences or related field.
• Hands-on experience in manufacture, development and scale-up of biological/pharmaceutical processes.
• Experience in GMP/GLP environments and documentation management.
• Experience preparing SOPs, protocols, manufacturing records and reports.
• Knowledge of immunological and biochemical techniques (ELISA, SDS-PAGE, Western Blot).
• Ability to work in multidisciplinary teams and with cross-functional departments.

Responsabilités

• Plan, manufacture and analyze Active Substance pilot batches and report results.
• Participate in development, optimisation and scale-up of biological manufacturing processes.
• Prepare and update SOPs, manufacturing instructions and technical records.
• Develop and execute analytical methods for material characterisation and QC.
• Participate in Change Control and documentation for new equipment and processes.
• Operate and verify lab equipment, supporting calibration and qualification.
• Ensure GMP/GLP compliance, data integrity and traceability.

Connaissances

English (C1)

Analytical skills

Problem solving

Autonomous working

Structured & organized

Collaboration

Quality & compliance mindset

Formation

University degree in Biology/Biochemistry/Biotech/Pharmacy/Health Sciences

Outils

SOPs management

ELISA

SDS-PAGE

Western Blot

Description du poste

ROXALL Medicina España in Zamudio is seeking an R&D Raw Materials Section Technician (SMP) to join the R&D Department on a permanent contract. You will work on development, manufacture, optimization and qualification of biological raw materials and active substances for allergen immunotherapy, covering pilot batch production, analytical testing and documentation within a regulated pharma setting.

The role combines hands-on laboratory work with manufacturing process scale-up, process