Scientist - Early Stage Drug Product Development

vor 3 Wochen


Munich, Deutschland BI Pharma GmbH&Co.KG Vollzeit

**The Position**:
***Tasks & responsibilities**:

- As Scientist you will lead drug product development on CMC (Chemistry, Manufacturing and Controls) relevant topics and support the development activities to enable clinical studies.
- This covers mainly all aspects of the formulation development of biologics at different development stages
- In your new role you will take over decisions on drug product relevant aspects and will represent the department in interdisciplinary teams.
- You enable ensure excellent interaction and collaboration with interfaces (e.g. Downstream Development, Analytical Development) as well as external partners.
- You take over technical and scientific guidance to your colleagues in the laboratory to establish and foster the implementation of new technologies and workflows.
- Based on your scientific knowledge, you will ensure that internal and regulatory principles are maintained in your working routine.
- Further tasks are delivery of high-quality data, presentations and reports including required documentation for regulatory filings (IND/BLAs).

**Requirements**:
- PhD in Biochemistry, Biology, Chemistry, Pharmacy is preferable or master’s degree with several years of working experience in formulation development- Strong technical expertise in formulation development of biologics (e.g. manufacturing, formulation screening, freeze-drying)- Profound expertise in analytical methods for biophysical characterization of antibodies/proteins- Project management skills and experience with an agile working culture are beneficial- Excellent organizational skills, ability to respond to changing priorities and short lead teams for multiple tasks and ability to identify problems and work towards solutions- Highly motivated and team-oriented working behavior with a talent to anticipate challenge early on- Excellent oral communication skills as well as sound technical writing and documentation competencies in English

**Ready to contact us?**:
Please contact our HR Direct Team, Tel: +49 (0) 6132 77-3330.

Recruitment process:
Step 2: Virtual meeting beginning/mid of September

Step 3: On-site interviews end of September/beginning of October



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