R&d Senior Cmc Associate
hace 3 días
Overview: **mAbxience i**s a global, vertically integrated fully-fledged **biotechnology company,** with over a decade of experience in the development, manufacture and commercialization of biopharmaceutical medicines. We incorporate the latest state-of-the-art technology in our development and manufacturing platform, across 3 multi product Drug Substance facilities and our partners filling sites. We are committed to global quality standards to manufacture & supply our products worldwide. 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. **Responsibilities**: - Design strategy for analytical similarity and comparability studies. - Support analytical characterization studies for CDMO projects. - Plan and execute studies with support from more junior members and input from other teams as required (e.g. project management): manage CROs, analyze and interpret analytical data, statistical analysis, 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. - Prepare/review investigators brochures, data packages for scientific advice, regulatory dossiers/variations data packages, and respond to requests from regulatory agencies. - Collaborate in the improvement of the R&D quality system. - Actively participate in SOPs development and updates - Lead/participate in scientific publications. - Participate in trainings/presentations to other R&D teams or mAbxience departments. - Mentor more junior members of the team. Qualifications: - **Education**: University Degree (Biochemistry, Chemistry, Pharmacy or Biology), PhD is a plus. - ** Languages**: Fluent English. Spanish desirable - ** Experience (years/area**)**:> 5 years’ experience in R&D > 2 years’ experience with biosimilars. Experience in QC/QA/Regulatory Affairs under GMP environment is valuable.****: - **Specific Knowledge**: - Strong knowledge of the pharmaceutical industry and biosimilars. - Strong knowledge of physicochemical analytical methods applied to protein/antibody characterization (HCPL based methods, Mass Spectrometry and electrophoretic methods). - Experience of working with third parties. - Knowledge of binding assay/bioassays is a plus. - Practical knowledge/experience as analytical laboratory technician is a plus. - Experience of working with CDMO companies is a plus. - 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.
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