Scientist* GMP/CMC Drug Product
Location
Mainz | Germany
Job description
Scientist* GMP/CMC Drug Product
As part of the CMC DP Operations team, you will contribute to the design and execution of CMC studies to contribute to technical reports for regulatory filing.
Your main responsibilities are:
- Independent planning, execution and reporting (incl. official reports to external partners or authorities) of numerous types of CMC laboratory experimental studies (e.g. in use and point of use stability, process compatibility and bridging of methods to a clinical setting); active lab work would be required
- Coordination and management (incl. self-responsible contacting manufacturers, CMOs, CROs etc.) of activities related to the material logistics, supply and inventory management for various CMC experiments and scenarios as well as acting as a first point of contact and bridging unit across departments
- Liaising with various departments and external partners to devise experimental plans and strategies to serve the CMC sections of Regulatory documents
- Responsibility for instruments, laboratory management, supervision of Student Assistants and Research Associates
What you have to offer.
- PhD in a relevant scientific area is preferable
- Experience in design process for formulation or product development gained in a pharmaceutical or biotech environment
- Knowledge or awareness of the regulatory documentation process for drug development
- Hands on experience with regulatory filings is preferable
- A multi-disciplinary background gained through working in analytical and pre-clinical development departments is preferable
- Strong planning expertise and a quality oriented approach to report writing
- Advanced knowledge in data analysis (e.g. excel, power BI, R) is preferable
- Coordination and management of internal and external partners
- Some experience in laboratory management and supervision of Student Assistants and Research Associates
- Fluency in English both written and spoken is a requirement; knowledge of German is advantageous
Benefits for you:
- Flexible Working Time
- Mobile Office
- Work from EU Countries
- 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 RoKo50 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 6627(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
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