Associate Director AS&T Manufacturing Network Mainz, Germany | full time | Job ID:9427 As Analytical Transfer Lead (Associate Director AS&T Manufacturing Network), you will be making a meaningful contribution to the ongoing development of our product pipeline as part of the Analytical Sciences and Technology (AS&T) team. In this role, you will be the main contact (SPoC) for analytical transfers at Contract Manufacturing Organizations (CMOs), Contract Testing Organizations (CTOs) and our internal sites. Furthermore, you will lead analytical transfers and the on-boarding into our BioNTech manufacturing- and testing- network, as well as the support of routine operations. Defining, maintaining, and facilitating the communication line between internal departments and sites and external collaboration partners and CMOs and supporting compliance and harmonization of analytical testing strategies as the main contact of CMOs/ new sites during on-boarding and/or transfer Leading analytical technology transfer projects in the internal and external manufacturing network Conducting analytical investigations and problem-solving activities during technology transfer and routine production Overseeing the creation/revision and approval of work instructions, transfer/validation documentation and other supporting documents Supporting the evaluation and implementation of new technologies required to maintain state-of-the-art analytical methods for development in alignment with internal and external stakeholders Providing support for troubleshooting and continuous improvement in the laboratory Essential Requirements University degree in biology, chemistry, pharmacy, biotechnology or comparable OR advanced degree in life science or healthcare (or equivalent) Several years of working experience in a regulated environment in Biotechnology or Pharmaceutical Industry, ideally under GMP, and good knowledge of the standard quality processes (OOS, deviations, Change control, CAPAs) Experience in leading analytical transfers covering method implementation, optimization, trouble shooting and validation, ideally in QC within the pharmaceutical industry Knowledge in analytics of therapeutic proteins (e.g. antibodies, ADCs), especially regarding analytical chemistry (e.g. HPLC), bioassays and/or ELISAs Excellent organizational skills, with the ability to manage multiple priorities and deliver results in a fast-paced environment Highly conscientious, detail-oriented, and problem-solving approach Effective communication skills (verbal and written), supportive team player, and excellent collaborating and stakeholder management skills Desirable Requirements Experience in managing analytical/ QC aspects at external partners (CMOs) Knowledge of relevant US, EU, EMA and FDA regulatory standards It's our priority to support you: Your flexibility: flexible hours | vacation account Your growth: Digital Learning | Performance & talent development | leadership development | Apprenticeships | LinkedIn Learning Your value: Your voice at the table | Culture on an equal footing | Opportunities to shape & impact | Support for your full potential Your health and lifestyle: Company bike Your mobility: Job ticket | Deutschlandticket Your life phases: Employer-funded pension | Childcare