The Position Boehringer Ingelheim develops cutting-edge viral therapeutics therapies with a focus on gene therapies, cancer vaccines and oncolytic viruses by combining its world class, in-house research and development with that of highly innovative external companies. In your new role as a scientist for drug substance development you can be part of building our new and innovative pharmaceutical development platform of viral therapeutics. Drug substance development starts in parallel with preclinical development and ends with a successful marketing authorization application (MAA) of a new pharmaceutical product. Join us to develop first-in-class immuno-oncology therapies for the benefit of our patients around the world. Tasks & responsibilities - In your new role, you will lead and coordinate drug substance related activities associated to the development of viral therapeutics, e.g. planning of studies, their execution and evaluation. - With your scientific expertise, you will lead and drive the process development and establish processes to produce therapeutic viruses for clinical studies. - As a drug substance expert, you will be responsible in leading interdisciplinary and international project teams. In your role, you will support clinical supply teams to transfer established processes to enable GMP manufacturing of drug substance. - You will be accountable for the drug substance chapters of CMC-part regulatory submissions, including the preparation and its representation towards health authorities. - Based on your solid expertise you will contribute to the overall drug substance manufacturing strategy, development of existing processes and apply new technologies. Requirements - Master´s degree in Pharmacy, Biotechnology, Biology, Virology, Biochemistry or equivalent; PhD degree is preferable, with initial professional experience in the development or manufacturing of virus or protein therapeutics - Solid knowledge and several years of professional experience in drug substance process knowledge and manufacturing, preferably in the field of viral/gene therapy/biological products - Knowledge of general GMP aspects and health authority guidelines requirements, preferably with a focus on ATMPs - Team player with excellent communication, negotiation, presentation and organization skills (internal and external global interfaces) - Agile, quick comprehension and high sense of quality and responsibility - Fluent in English and/or German, written and spoken. Ready to contact us? Please contact our HR Direct Team, Tel: 49 (0) 6132 77-3330. Recruitment process: Step 1: Online application - application deadline is 28.11.2024 Step 2: Virtual meetings in the end of november Step 3: On-site interviews beginning of december Please submit your application documents in English. Discover our Biberach site: xplorebiberach.com All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.