(Associate) Director* Analytical Chemistry
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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* Analytical Chemistry
The (Associate) Director Analytical Chemistry will be part of the project team leading external development and manufacturing of small molecules and antibody drug conjugates (ADCs). He/she will provide scientific and technical input to small molecule and ADC linker-payload development programs related to all analytical matters and will be responsible for review and approval of external development documentation according to regulatory expectations. Based on the CMC development strategy, the (Associate) Director Analytical Chemistry will also provide strategic and scientific input in the assigned development programs being responsible for establishment and execution of the analytical strategy. In addition, the (Associate) Director Analytical Chemistry will serve as a direct contact for CDMO partners related to analytical topics for small molecules and ADC linker-payloads.
Your main responsibilities are:
- Represent analytical expertise (molecule characterization, quality control, in-process analytics, raw material analytics etc.) in assigned development projects.
- Establish close technical collaboration with internal stakeholders and external partners
- Create, review, and approve (external) project documentation, including method development reports, risk analysis, and qualification/validation reports according to regulatory guidelines
- Manage CMC timelines with respect to analytical development activities and implement risk management, including proactive mitigation plans to help ensure effective program execution
- Drive timely and data-driven decision making, and contribute to strategic discussions within CMC as well as with other internal stakeholders and external partners
- Drive continuous improvement of analytical performance and data quality, through optimizing analytical technologies, automation, and digitalization
What you have to offer.
- Master’s degree or preferably PhD in analytical chemistry or similar with at least 5 years of relevant professional experience in an international and highly regulated environment
- Deep expertise in analytical technologies for chemical entities including technologies for physicochemical characterization (salt and polymorphism screening by XRPD, DSC, TGA, DVS etc.)
- Experience with high potent drugs and antibody drug conjugates is considered a plus
- Proven experience in CMC development of early- and/or late-stage projects, including strategy definition and strategy execution, with a sound understanding of all stages of the drug development process.
- Experience with generation of regulatory documents and regulatory filings (IND/IMPD, BLA/MAA)
- Leadership/management skills and assertiveness, capable of working in cross-functional CMC teams and with external stakeholders
- Excellent communication and negotiation skills as well as ability to communicate complex technical matters in a clear and concise way (e.g., to senior management)
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 7805 (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!
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