Director AS&T Projects & Strategy
Mainz, Germany | full time | Job ID: 11261
As Director AS&T Projects & Strategy - Analytical Lead you will be making a meaningful contribution to the ongoing development of our late-stage protein pipeline for Antibody drug conjugates (ADCs) products as part of our Analytics, Science & Technology (AS&T) department. In this role, you will be the central point of contact and responsible for the co-ordination of all analytical activities within the internal and external analytical network. Further, you will be representing the analytical network in the interdisciplinary late-stage CMC team to advance development projects to the market.
Your responsibilities:
· Represent analytics in interdisciplinary teams and act as single point of contact for the CMC team and all relevant stakeholders.
· Ensure successful management of all analytical activities and actively report the status (progresses, delays, risks) to the relevant (cross-functional) stakeholders.
· Coordination of analytical tasks within the internal analytical network and external partners in line with the overall analytical strategy.
· In charge of defining and aligning the analytical control strategy across departments (e.g. Regulatory Affairs, CMC, Quality). Ensure that the proposed strategy is in line with health authority guidelines and regulatory requirements.
· Take full ownership of the analytical CMC Module 3 package (authoring, review, lifecycle management).
What you have to offer:
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 comparable) optional PhD or equivalent qualification.
· Industry experience (10+ years) within biotech or pharmaceutical industry, strong background in analytical CMC activities for mAbs and/or work experience in mAb QC and/or analytical development.
· Proven track record in analytical late-stage antibody development, ideally including antibody-drug conjugates (ADCs).
· Demonstrated leadership and analytical project management experience.
· Profound knowledge of relevant US and EU, EMA, FDA regulatory standards, CMC analytical development packages, Good Manufacturing Practices, as well as the USP (United States Pharmacopoeia), and Ph. Eur. (European Pharmacopoeia).
· Experience with pre-approval activities (e.g. PAI, BLA preparation, launch activities) is a plus.
· Fluent English and technical writing skills.
· Experience in working in intercultural, cross-functional 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 fast-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 11261 (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.