The Scientist II, Molecular Biology, will take a leading role in verification and validation (V&V) and change validation of instrument systems with the emphasis on molecular biology and biochemistry. The successful candidate will provide technical expertise on a project and department level and will be encouraged to integrate into a dynamic and multidisciplinary team. The successful individual is required to exhibit a results oriented attitude with the ability to thrive in the fast paced environment of biotechnology.
They will possess the technical capacity to develop experimental hypotheses, design and perform experiments, analyze data sets, and write protocols and reports. Furthermore, they will present their findings to external and business partners. They are expected to have good practical knowledge of molecular biology techniques, such as PCR, qPCR, capillary electrophoresis, NGS.
What will you do?
They will represent the V&V function in project core team for molecular biology assays, software integration and/or instrument integration or development. The main responsibility of this person is to lead test method development and validation while adhering to internal policies and procedures, as well as external quality standards. This scientist shall exercise independent judgment within defined procedures and practices to decide appropriate action.
Skills such as problem solving using knowledge of technical product details, design control and basic regulatory issues are desired. Recommendation to implement changes to processes, procedures or products within the department are encouraged. Possessing strong digital literacy and ability to handle complex data sets are required. This scientist will also mentor and lead training of junior scientists in the team, which include reviewing and approving junior scientist's work.
I. Education
- Required - Master's degree in Chemistry, Biochemistry, Molecular Biology or similar (at upper second-class level) with proven experience of at least 4 years. Fresh Ph.D. can apply.
II. Experience
- Extensive hands-on experience with molecular biology methods.
- Experience with analytical techniques used for antibody/protein analysis
- Experience with statistics packages, e.g. JMP, Minitab.
- Prior working experience in immunotherapy, stem cell, or hematology research is considered as a valuable advantage
III. Knowledge, Skills, Abilities
- Able to craft test plan and carry out experiments for proof-of-concept testing.
- Able to write test plan & report, design test matrix, develop test protocols.
- Possess good laboratory and documentation practices.
- Knowledge of IVD process for MDx and experienced at working at ISO 13485 will be an advantage.
