La positionPharma Technical Development brings game-changing therapies from clinical phase I into the market to serve every patient, every day. Our core business is to develop safe, innovative and effective drugs using cutting edge technologies for manufacturing process (Drug Substance and Drug Product), clinical supply, analytics, formulation, device and packaging. Our daily work includes authoring of regulatory documents and the transfer of development projects to the commercial organization.We are striving for a caring and sensing network organization which lives a culture of trust and collaboration. Our smart people drive innovation through their expertise, passion and "getting it done" mentality. The benefit for the patient is in the center of our thoughts and efforts.The department Analytical Development and Quality Control (ADQC) Biotech is responsible for Biochemical and Biophysical Analytical Development, Quality Control and Compliance for Biopharmaceuticals Drug Products from pre Investigational New Drug (IND) to New Drug Application (NDA) and Launch.The OpportunityServe as analytical project lead representing ADQC in global technical development teams including the coordination of all necessary analytical activities for biotechnological development productsDirect leadership responsibility for a team of approx. 6 associates / scientists incl. piroritization of workloadSetting of specifications and shelf life for investigational medicinal products and support of IND and BLA (Biologics License Application) filingsEvaluation, implementation, and further development of new technologies/ test methods to ensure state of the art analytics including analytical method validation and transferQuality control for investigational medicinal products and batches used in preclinical and clinical studiesCreation of prerequisites for securing a competent, efficient GxP conform analytics in due time and keeping the current GxP guidelines as well as the relevant SOPsWho you areYou are someone who wants to influence your own development. You are looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point. Additionally to that we are looking for the following qualifications and experience:PhD in Analytics, Biochemistry, Pharmacy or similar scientific qualification and a minimum of 3-5 years experience in biopharmaceutical industry with focus on protein analytics and characterization, preferably in a GMP environment. Experience with combination products is a plus.Experience in development of new technologies and methods for biophysical/biochemical analysis and characterization of proteinsExcellent leadership skills and a track record in cross functional collaboration. Ability to influence stakeholders at all levels will be essential in this roleSelf-motivated, pro-active, responsible, result-oriented and an excellent team player with success in building trustful relationshipsStatistics expertise (e.g. statistical models and their application) and high affinity to digitalization is preferredThis is initially a 2 year contract.If you are an experienced scientist looking to make an impact in a cross functional setting, we would love to hear from you. Please apply by submitting your updated CV and cover letter via our careers portal.Qui nous sommesUn avenir plus sain nous pousse à innover. Ensemble, plus de 100 000 employés à travers le monde sont dédiés à faire progresser la science et à garantir à chacun l'accès aux soins de santé aujourd’hui et pour les générations à venir. Nos efforts aboutissent à plus de 26 millions de personnes traitées avec nos médicaments et plus de 30 milliards de tests réalisés avec nos produits de Diagnostique. Nous nous encourageons mutuellement à explorer de nouvelles possibilités, à favoriser la créativité et à conserver nos grandes ambitions, afin de fournir des solutions de santé qui changent des vies et ont un impact mondial.Construisons ensemble un avenir plus sain.Roche est un employeur offrant l\'équité en matière d\'emploi.
#J-18808-Ljbffr