Your main responsibilities are.
* Act as the analytical lead or subject matter expert (SME) in early and late-stage development programs, providing comprehensive expertise and strategic input
* Lead analytical sub-teams and ensure seamless coordination between project teams and SMEs
* Develop and oversee the analytical development plan (including method implementation, validation & transfers, reference standard qualification, and stability studies) and align with CMC project strategies and requirements
* Support Quality by Design (QbD) initiatives, including QTPP, CQA assessments, and the development of the analytical control strategy
* Oversee analytical activities related to manufacturing & supply of investigational medicinal products (IMPs) for clinical trials
* Contribute to deviation and change management and lead analytical comparability exercises
* Provide scientific input for briefing books, regulatory submissions, and scientific advice meetings and ensure regulatory compliance for analytical sections of dossiers (e.g., IMPD, IND, BLA)
What you have to offer.
* Master’s degree or preferably PhD in Pharmacy, Chemistry, Biopharmaceuticals, Biochemistry, Biology, or a comparable field with at least 5 years of relevant professional experience in an international and highly regulated environment
* Proven experience in protein and ADC analytical technologies (physico-chemical assays, functional assays, quality control); knowledge in small molecule analytics is considered a plus
* General experience in CMC development of early- and late-stage projects, including strategy definition and strategy execution, with a sound understanding of all stages in the drug development process
* Sound GMP knowledge and experience with regulatory filings for biologicals (IND/IMPD, BLA/MAA)
* Excellent project management skills, capable of working in cross-functional CMC teams and with external stakeholders
* Excellent communication and negotiation skills (English required, German is a plus) as well as ability to communicate complex technical matters concisely to various stakeholders
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; Munich, Germany 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 12 PM to 4 PM CET).
Job ID 9844 (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.