Mainz, Germany; Gaithersburg, US | full time | Job ID: 9427
This position can be filled either in Mainz (Germany) or Gaithersburg (US).
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.
Your responsibilities:
* 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
What you have to offer:
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
Your Benefits:
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
Apply now - We look forward to your application!
Apply to our Mainz, Germany; Gaithersburg, US location by sending us your documents via our online form. For any questions, contact our talent acquisition team on: + 49 (0) 6131-9084-1291 (Monday-Friday from 1 PM to 3 PM CET).
Job ID 9427 (please always specify if you have any questions)
By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech-Recruiter.