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R&D CMC SENIOR ASSOCIATE

Descripción de la oferta de empleo

GLOBAL RESPONSIBILITY Responsible for leading R&D CMC activities related to product development including demonstration of analytical similarity and comparability, coordinating activities with other R&D functions and project management to deliver activities on time. Provide input to the core team as required to ensure successful products development. Provide support to regulatory Affairs for scientific advice, RA dossiers creation and updates, and deficiency letters. Suggest and develop teams SOPs. Mentor more junior members of the team.SPECIFIC RESPONSIBILITIESDesign strategy for analytical similarity and comparability studiesPlan and execute studies with support from more junior members and input from other teams as required (e.g. project management): manage CROs, analyze analytical data, identify and interpret trends or patterns in complex data sets, identify outliers, request complementary information and seek clarifications as required. Look for scientific literature to support/illustrate findings.Write and review reports with high quality. Ensure data traceability at all timesPrepare/review investigators brochure, data packages for scientific advice, regulatory dossiers/variations data packages, and respond to requests from regulatory agencies Mentor more junior members of the teamActively participate in SOPs development and updatesLead/participate in scientific publicationsParticipate in trainings/presentations to other R&D teams or mAbxience departmentsREQUIREMENTSEducation: University Degree (Biochemistry, Chemistry, Pharmacy or Biology), PhD is a plus.Languages: Fluent English. Spanish desirableExperience (years/area): > 5 years experience in R&D and > 2 years experience with biosimilars.Specific Knowledge: Strong knowledge of the pharmaceutical industry and biosimilars. Knowledge of analytical methods applied to protein analyses. Practical knowledge/experience as analytical laboratory technician is a plus. Experience of working with third parties. Advanced knowledge of Excel including basic statistical analysis. Advanced use of Microsoft Word, PowerPoint, and Outlook.Personal skills: Ability to lead projects, team player, able to work in multicultural team environment. Strong analytical skills and organization skills. Good attention to detail and accuracy. Disposition to learn.Travels:
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Detalles de la oferta

Empresa
  • mAbxience
Localidad
  • En toda España
Dirección
  • Sin especificar - Sin especificar
Fecha de publicación
  • 18/12/2024
Fecha de expiración
  • 18/03/2025
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