Associate Director* AS&T Lifecycle Management
Become a member of the BioNTech Family!
As a part of our team of more than 5.000 pioneers, you will play a key role in developing solutions for some of the most crucial scientific challenges of our age. Within less than a year, we were able to develop our COVID-19 mRNA vaccine following the highest scientific and ethical standards – writing medical history.
We aim to reduce the suffering of people with life-changing therapies by harnessing the potential of the immune system to develop novel therapies against cancer and infectious diseases. While doing so, we are guided by our three company values: united, innovative, passionate. Get in touch with us if you are looking to be a part of creating hope for a healthy future in many people's lives.
Associate Director* AS&T Lifecycle Management
This vacancy is limited.
Associate Director* AS&T Lifecycle Management - Instrumental Analytics
As Associate Director* AS&T Lifecycle Management for Instrumental Analytics you will be making a meaningful contribution to the ongoing development of our late stage project pipeline (including RNA and Protein products) as part of our Analytics, Science & Technology (AS&T) department. In this role, you will be responsible for the development and supervision of Lifecycle Management for Instrumental Analytics in the internal and external laboratory network.
Your main responsibilities will be:
- Responsibility for analytical methods within AS&T working groups and project teams (e.g., tech transfers), i.e. implementation, validation, trending, and continuous improvement
- Identifying, qualifying and managing usage of respective methods of internal and contracted laboratories to assure compliance with current Good Manufacturing Practice (cGMP)
- Representing Quality Control (QC) in internal and external cross-disciplinary teams as responsible expert for method life cycle and analytical transfers
- Providing input for process validation activities and compilation of Module 3 content for late stage development projects
What you have to offer.
We are looking for an enthusiastic, committed, and visionary individual, ideally with the following characteristics:
- University degree in a scientific discipline (Biochemistry, Chemistry, Microbiology, Biotechnology)
- Several years of work experience in QC within biotech or pharmaceutical industry, especially working in the field of Instrumental Analytics (e.g. HPLC, CE)
- Experience in analytical method development, method transfer and method validation with a focus on RNA, monoclonal Antibody and Antibody Drug Conjugates analytics
- Profound knowledge of relevant US and EU, EMA, FDA regulatory standards, Good Manufacturing Practices, as well as the USP (United States Pharmacopoeia), and Ph. Eur. (European Pharmacopoeia)
- Conscientiousness and detail-orientation
- Creativity and the ability to develop a flexible approach to changing conditions
- Great communication skills, incl. technical writing, and fluency in English and German
Benefits for you:
- Flexible Working Time
- Mobile Office
- Work from EU Countries (up to 20 days per year)
- Company Pension Scheme
- Childcare
- Jobticket
- Company Bike
- Leave Account
- Fitness Courses
... and much more.
Have we kindled your pioneering spirit?
Then apply now for our location Mainz Goldgrube and simply send us your application documents using our online form.
If you have any further questions, our Talent Acquisition Team will be happy to answer them on + 49 (0) 6131-9084-1291 (monday-friday, from 12 noon to 4 pm).
Job-ID 5945 (please indicate for inquiries)
We look forward to your application!
*BioNTech does not tolerate discrimination, favoritism, or harassment based on gender, political opinion, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other aspect of personal status. We are committed to creating a diverse and inclusive environment and are proud to be an equal opportunity employer. Most important – it’s a match!
BioNTech - As unique as you
www.biontech.com