Mainz, Germany | full time | Job ID: 9407
Associate Director Potency Assays - AS&T Lifecycle Management
As Associate Director Potency Assays, you will be making a meaningful contribution to the ongoing product development and regulatory submission (BLA/MAA) of our Protein-based therapeutic pipeline as part of our Analytics, Science & Technology (AS&T) department.
In this role, you will be the main point of contact for specific methods within your area of expertise. You will ensure that the analytical methods comply with GMP standards and provide accurate, precise, and reliable results.
Your Contribution:
* Provide technical analytical expertise in the field of potency assays for late-stage and commercial projects across a global network
* Responsible for the design and performance of method validation and transfer strategies as well as method lifecycle activities (e.g. exchange of critical reagents, method performance and laboratory investigations)
* Participate in strategic and technical discussions within projects cross-functionally with CMC team members and external partners
* Evaluation and review of technical and regulatory submission documents in a timely manner for the approval and market launch of development products
* Act as analytical SME by providing expert knowledge for regulatory filings, as well as contributing expertise to questions from health authorities and responses to regulatory submissions
A Good Match:
We are looking for an enthusiastic, committed, and visionary individual, ideally with the following characteristics:
* An advanced university degree in a scientific discipline (Biology, Chemistry, Pharmacy, Biotechnology, or a related field)
* Industry experience (5+ years) in a regulated environment in the pharmaceutical industry; managerial experience in a potency assay laboratory is considered a plus
* In-depth knowledge of cell-based and immunoassays for determining potency and biological activity, which reflect the mechanism of action of a product (e.g. Cell Proliferation and Cytotoxicity Assays, ELISA, and Flow Cytometry)
* Hands-on experience with assay development, design and performance of method validations, as well as data analysis and statistical evaluation
* Expertise in analysis of relative potency, including parallel line analysis and slope-ratio models, as well as combination of relative potency replicates.
* Experience in assay control strategies and lifecycle management of relative potency assays, including SST parameters and assay bridging.
* In-depth knowledge of ICH guidelines, GMP regulations, and industry best practices
* Experience in working in intercultural, cross-functional, and global teams
* Structured way of working, ability to understand and break down complex challenges and plan associated timelines and interdependencies
* Highly motivated and willingness to work in a fast-paced and evolving environment
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 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 9407 (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.