Analytical Transfer Lead
Mainz, Germany | full time | Job ID:9104
As Analytical Transfer Lead (Associate Director AS&T Manufacturing Network), you will be making a meaningful contribution to the ongoing development of our mRNA production processes 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
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 in molecular biology, microbiology and/ or analytical chemistry, especially HPLC
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