R&D Researcher CDMO Analytical Methods
HIPRA es una empresa farmacéutica y biotecnológica enfocada en la prevención y diagnóstico para salud animal y humana, con una amplia gama de vacunas altamente innovadoras y un avanzado servicio de diagnóstico.
Tiene una sólida presencia internacional en más de 40 países con filiales propias, 11 centros de diagnóstico y 6 plantas de producción ubicadas estratégicamente en Europa (España) y América (Brasil).
La investigación y el desarrollo constituyen el núcleo de su conocimiento. HIPRA dedica el 15% de su facturación anual a actividades de I+D que se concentran en la creación y aplicación de los últimos avances científicos para el desarrollo de vacunas innovadoras de la más alta calidad. Para darle un valor añadido a su experiencia en vacunación, la empresa también desarrolla dispositivos médicos y servicios de trazabilidad.
At HIPRA Biotech Services, we are seeking an R&D Researcher CDMO - analytical methods - to contribute to the launch and consolidation of our newly created R&D CDMO unit, a dedicated team established to provide Cell Line Development, Process Development, and Analytical Development services to external clients.
This position is based in Aiguaiviva (Girona)
In this role, you will accompany clients throughout the entire development lifecycle, from early discovery and process setup through process development, process optimization, transfer to real industrial scale, process characterization, and support for clinical and commercial manufacturing stages. This position provides broad exposure to how biologics are developed, transferred, and manufactured within a CDMO environment.
You will be part of a multidisciplinary R&D team responsible for the technical coordination of client projects, working closely with internal specialists in Cell Line Development, Process Development, and Analytical Methods. The role combines hands-on scientific work with strong coordination and communication responsibilities, offering a comprehensive and transversal view of biological development.
QUALIFICATIONS
Ph.D. in Biotechnology, Bioengineering, Pharmacy, or a related field with at least 1 year of industrial experience in biologics process development, or alternatively at least 3 years of equivalent experience without a Ph.D.
Solid background in analytical methods for biologics, either biochemical/biological (e.g. ELISA, qPCR, bioassays) and/or physicochemical (e.g. SEC-HPLC, CE-SDS, icIEF, peptide mapping).
Experience in analytical method development, transfer, qualification, and/or validation.
Understanding of GMP and regulatory expectations related to analytical methods.
Strong organizational and coordination skills, beyond hands-on laboratory execution.
Ability to interact effectively with clients and multidisciplinary internal teams.
Experience preparing and reviewing analytical documentation.
Proactive, curious, well-organized, and solution-oriented individual
Strong communication skills, with the ability to interact effectively with clients and multidisciplinary internal teams.
Fluent in written and spoken English.
KEY RESPONSIBILITIES
Coordinate and support analytical method development activities for biologics projects within R&D.
Lead and support analytical method transfer from clients, including review of analytical packages, validation history, and method performance.
Act as a technical interface between clients and internal analytical teams, ensuring alignment on analytical scope, acceptance criteria, timelines, and regulatory expectations.
Support and coordinate analytical method qualification and validation activities in GxP environments.
Contribute to analytical troubleshooting during development, technical, engineering, and GMP batches.
Provide analytical support during GMP manufacturing at industrial scale, ensuring continuity between development, validation, and routine testing.
Contribute to the definition of analytical strategies supporting process development, characterization, comparability, and validation activities.
Prepare, review, and coordinate analytical documentation (method descriptions, transfer protocols, validation plans and reports).
Collaborate closely with Process Development, Quality, Manufacturing, and external partners to ensure coherent project execution.
Participate in technical meetings with clients, audits, internal project meetings, and on-site visits.
Contribute to the continuous improvement of analytical development, method transfer, and validation workflows within the CDMO organization.
HIPRA ofrece igualdad de oportunidades a todos sus trabajadores y trabajadoras.
Todos los/las solicitantes que reúnan los requisitos serán considerados para el puesto a cubrir, sin tener en cuenta el género, la raza, la nacionalidad, la condición de discapacidad o de edad.
Todas las decisiones de contratación se toman en base a los méritos, la competencia y las necesidades de la empresa.
