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Become a member of the BioNTech Family! As a part of our team of more than 5.000 pioneers, you will play a key role in developing solutions for some of the most crucial scientific challenges of our age. Within less than a year, we were able to develop our COVID-19 mRNA vaccine following the highest scientific and ethical standards - writing medical history. We aim to reduce the suffering of people with life-changing therapies by harnessing the potential of the immune system to develop novel therapies against cancer and infectious diseases. While doing so, we are guided by our three company values: united, innovative, passionate. Get in touch with us if you are looking to be a part of creating hope for a healthy future in many people's lives. Associate Director Bioanalytics As subject matter expert (SME) Bioanalytics you are responsible for delivering methods for PK, ADA and biomarker analytics required for all phases of clinical trials as well as cell based biopotency methods, each outsourced to external contract laboratories. Contribution to implement biomarker testing and biopotency assay strategy of multiple clinical trial projects Selection of appropriate analytical technologies in collaboration with R&D teams and departments Translational Sciences, Clinical Pharmacology and CMC Contribute to the global selection and management of contractors in terms of their technical appropriateness and compliance with the respective regulatory requirements Responsibility for method transfer to or method development at external vendors (contract labs) Responsibility for oversight of contract laboratories that perform feasibility studies, (further) development, and appropriate analytical validation of methods Degree in pharmacy, chemistry, biology, biochemistry, or equivalent A minimum of 5 years of experience in regulated pharmaceutical or regulated biotech industry Solid experience in assay development and analytical validation of methods for PK, ADA and biomarker testing or cell based biopotency assays. In-depth knowledge of GCP/GLP and/or GMP Quality Control as well as FDA and EMA requirements. Ability to express complex issues in concise and clear language, very good English (written and spoken) and German (desired) Ability to identify problems and find solutions, as well as attention to detail BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base. We offer competitive remuneration packages which is determined by the specific role, location of employment and also the selected candidate's qualifications and experience. Click here to find out more about what we do, the careers we offer ans also the benefits we provide. Note: The availability, eligibility and design of the listed benefits may vary depending on the location. The final requirements for the individual use of our benefits are based on the company's internal policies and applicable law.