Senior Scientist, Molecular Diagnostics

The role, within the assay development team, will contribute to the design and development of lab-based and POC molecular diagnostic solutions for infectious diseases, using the pulse-controlled amplification (PCA) core technology. HP Health Solutions Germany, located in the science hotspot Martinsried near Munich, is a subsidiary of HP Inc. and develops diagnostic instruments and assays for ultrafast detection of pathogens.

Please note that this is a temporary (24-month) contract.

**Responsibilities**
- Design, perform, and analyze data of complex experiments. Carry out multivariable data analysis (Excel, JMP) and communicate results (written, verbal, presentation) internally and externally.
- Plan work package activities. Support the manager in high-level project planning and implementation. Make independent decisions to allow timely progress of the plan. Guide a small team of scientists in planning and decision-making processes.
- Support development, freeze, and verification of diagnostic tests. Take responsibility for the planning of complex development and verification studies. Guide the team in the execution and analysis of results.
- Communicate with engineers and researchers across the program. Support the effective integration of sub-systems and planning of product performance test studies.
- Comply with quality standards (ISO13485); adhere to good laboratory practice guidelines, support continuous improvement of protocols and procedures. Adhere to activity, data, and results traceability system and monitor its implementation.

**Education and Experience**
- PhD in Molecular Biology or related disciplines with >4 Years of Biotech or equivalent industry experience is required
- Recommended experience with biotech product development preferably in vitro diagnostics (IVDD 98/79/EG and/orFDA 510k)
- Knowledge and experience in molecular diagnostics technology: Multiplexed PCR and qPCR or isothermal amplification tests design and development is required
- Knowledge and experience of biochemistry methods for sample lysis and purification and sample preparation technologies for molecular target detection
- Knowledge and experience with fungi, bacterial and viral pathogens culturing, processing of infectious human samples, and relative laboratory practice and regulations (BSL2) is ideal
- Experience working under Quality Systems (QMS) and adhering to international quality standards and protocols (ISO) is required
- Experience with e-lab book for data traceability
- Independent, self-motivating, and a self-driven work ethic. Ability to support, guide, and motivate team members
- Reliable, flexible, and available to accommodate shifts in working hours when required
- Remarkable problem-solving and decision-making ability with a strong analytical skillset
- Excellent written and verbal communication skills, including the ability to prepare and deliver compelling presentations and work on analyses at varying levels of granularity
- Software proficiency with basic text, data and presentation tools, and graphic and analysis software (JMP, GraphPad, Python, R)
- Fluent in English with very high proficiency in both written and verbal communication is required

**About the team**:

- The assay development team focuses on the design, development, and verification of molecular tests for the diagnosis of human infectious diseases. Our activity sits on a multidisciplinary crossroads between biochemistry, molecular biology, mechanics, optics, and software technology and requires a multifaceted approach to product development. We aim to support the development of molecular tests for a faster and more accurate diagnosis._