PbIn a nutshell /b /ppbr/ppPosition: Extractables and Leachables Senior Scientist /ppLocation: Azuqueca de Henares /ppExperience: at least 4-6 years in the development of the position and duties described /ppbr/ppbWant to know more? /b /ppbr/ppINSUD PHARMA operates across the entire pharmaceutical value chain, providing expertise and experience in scientific research, development, manufacturing, sales and marketing of a wide range of active pharmaceutical ingredients (APIs), finished dosage forms (FDFs) and branded pharmaceutical products, with added value for human and animal health. /ppbr/ppINSUD PHARMA's activity is organised into three synergistic business areas: Industrial (Chemo), Branded (Exeltis) and Biotech (mAbxience), with more than 9,000 professionals in over 50 countries, 20 state-of-the-art facilities, 15 specialised RD centres, 12 commercial offices and more than 35 pharmaceutical subsidiaries, serving 1,150 customers in 96 countries around the world. INSUD PHARMA believes in innovation and sustainable development. /ppbr/ppbr/ppbWhat are we looking for? /b /ppbr/ppWe are recruiting a bExtractables and Leachables Senior Scientist /b to join the RD team at one of our plants located in Azuqueca de Henares. /ppbr/ppbr/ppbThe challenge! /b /ppbr/ppThis position will be part of EL Team, and will bring hands-on and in-depth technical leadership experience in mass spectroscopy, E L for both medical device and drug products. /ppbr/ppThis role will design strategies for laboratory work in mass spectroscopy and EL including independent technical leadership of laboratory studies at in-house. The candidate will also act as the study incharge for multiple studies at any given time. The individual is expected to be a proven expert in EL for devices and pharma products. The individual will write required reports (internal documentation and regulatory submissions) following guidelines. The individual will train and mentor other team members. /ppbr/ppbSpecific responsibilities /b /ppbr/pulliPerform EL assessments and work with team members to determine a comprehensive testing strategy through gap assessments, technical documents related to EL /liliMaintain and apply current knowledge of relevant Quality System Regulations and other regulatory requirements related to chemical characterization, extractables for devices and pharma products. /li /ulpbr/ppbWhat do you need? /b /ppbr/pulliMaster of Science with a minimum of 6 years of relevant experience, or a PhD with a minimum 4 years of relevant experience /liliHands-on Experience and demonstrated expertise in EL testing /liliExperience in leading EL studies, working in cross-functional teams and executing projects on-time and on-budget /li /ulpbr/ppPreferred Skills: /ppbr/pulliExpertise in regulatory expectations for E L and mass spectrometry techniques. /li /ulpbr/ppbr/ppbr/ppbOur benefits! /b /ppbr/pp⏰Monday to Friday working hours, with flexible start times between 8:00 a.m. and 9:30 a.m. and finish times depending on start time, from 4:30 p.m. onwards. /pp Permanent contract. /pp Attractive salary package. /p