R&D Researcher CDMO Analytical Methods
1 day ago
Aiguaviva
HIPRA is a pharmaceutical and biotechnological company focused on prevention and diagnosis for animal and human health, with a broad range of highly innovative vaccines and an advanced diagnostic service. ¿Es usted el solicitante adecuado para esta oportunidad? Descúbralo leyendo el resumen del puesto a continuación. HIPRA has a solid international presence in more than 40 countries, with its own subsidiaries, 11 diagnostic centres and 6 production plants strategically located in Europe (Spain) and America (Brazil). Research and Development constitute the core of its knowledge. HIPRA dedicates 15% of its annual turnover to R&D activities that concentrate on the creation and application of the latest scientific advances to the development of the highest quality innovative vaccines. To give added value to its vaccination experience, the company also develops medical devices and traceability services. 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. 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. 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. xcskxlj, • Fluent in written and spoken English. #J-18808-Ljbffr
