Senior Scientist Project Analytics (gn)
Formycon is a leading, independent developer of high-quality biopharmaceutical medicines, especially biosimilars.With an experienced team comprised of more than 200 professionals, the company is able to span the entire value chain of biosimilar drug development, from market analysis and target definition by protein analytics, to the development of production processes, to clinical trials and the regulatory approval process.
Formycon is making a major contribution towards providing as many patients as possible with access to vital and affordable medicines. Based on its extensive experience in the development of biopharmaceutical drugs, the company is also working on the development of a COVID-19 fusion protein.
To support our Project Analytics team in Martinsried near Munich, we are looking for suitable candidates for this full-time and permanent position, to begin work as soon as possible.Your responsibilitiesThe project analyst is the single point of contact regarding overarching as well as in-depth analytical assessments. As such the position holder interacts with a variety of internal and external customers and ensures the timely delivery of high-quality analytical summaries in the form of key documents for development and submission.
This includes the following responsibilities:
- Be the single point of contact in analytics for internal and external customers
- Lead and plan analytical activities
- Ensure timely delivery of analytical project tasks in high quality
- Represent the analytical team in technical team meetings
- Closely interact with project management, regulatory CMC, and analytical experts
- Compile and review overarching documents with focus on analytics (e.g. analytical development masterplan, similarity assessment, DS/DP comparability)
- Participate in meetings with regulatory agencies (EMA, FDA)
- Answer analytical requests from authorities in close collaboration with technical experts
- Present analytical project updates in internal and external meetings
- Contribute to budget planning activities
- Degree in biology, chemistry, biochemistry or a related field
- A minimum of 3 years’ experience in the biopharmaceutical industry or a highly related field
- Applied in-depth knowledge of (glyco) protein analytics
- Passion to deliver against tight timelines
- Very good team player, result-oriented, well organized, proactive, problem solver and able to work independently
- Fluent in written and spoken English required, German knowledge is desirable
- Proficient in MS-Office
- Creativity and enthusiasm for working in a dynamic fast-growing biopharmaceutical company
- German work permit is mandatory
- Flexible working time
- Hybrid work
- 30 days paid vacation
- Formycon pension
- Group accident insurance
- Formycon card
- Continuing education offers
- Team spirit, great working atmosphere and much more!