R&D CMC ASSOCIATE

GLOBAL RESPONSIBILITY Support projects development within the R&D department and provide support to R&D Senior members. Help to coordinate and manage analytical assessments at internal and external laboratories. With support from Senior members, critically review reports, make data entry into department templates to facilitate statistical analysis and critical assessment; participate in writing of internal reports and presentations. Manage simple projects to ensure data are delivered on time & with high quality. Help manage R&D documentation. SPECIFIC RESPONSIBILITIES Conduct data entry in departmental templates ensuring all data traceability.With help of senior members: Interpret analytical data and analyze results using basic statistical techniques. Identify, analyze and interpret trends or patterns in complex data sets. Critically review internal and third parties data/reports, request complementary information and seek clarifications as required.Oversee specific third parties activities and ensure project progress.Participate in internal reports writing and presentations.Look for scientific literature to support/illustrate findings.Organize and follow-up sample shipments according to the company policy and third parties requirements. Participate in the elaboration of internal SOPs. Manage R&D Documentation according to SOPs including archiving. REQUIREMENTS Education: University Degree (Biochemistry, Chemistry, Pharmacy or Biology), PhD is a plus.Languages: Fluent English. Spanish desirableExperience (years/area): 2-6 years experience in R&D. laboratories Specific Knowledge: Knowledge of the pharmaceutical industry and understanding of biosimilars. Knowledge of analytical methods applied to protein analyses, including HPLC based assays and bioassaysPractical knowledge/experience as analytical laboratory technician is a plus. Experience of working with third parties is a plus. Advanced knowledge of Excel including basic statistical analysis. Advanced use of Microsoft Word, Excel and PowerPoint. Knowledge of statistical software is a plus.At mAbxience, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.