Are you interested in joining a Molecular Analytics group within Analytical R&D department in the US? If so, we are looking for a highly motivated Scientist for this high impact role and the Scientist Molecular Analytics position could be an ideal opportunity to explore. As a Scientist Molecular Analytics, you will work with high-performing CMC scientists on industry disruptive technology platform. The primary role of this Scientist will be to design and develop analytical methods, using Quality by Design (QbD) principles, to support drug substance/drug product characterization, product and process development and/or, the development and transfer of release methods for GMP testing, for the entire local US products portfolio of Technical R&D. He/she will be involved in implementing NGS technology to enhance CMC platforms and has the opportunity to serve as Subject Matter Expert in NGS data analysis. The successful candidate will work in a highly collaborative environment and spend 50-70% of the time in the lab. This role will provide YOU the opportunity to lead key activities to progress YOUR career.
These responsibilities include some of the following:
o Develop, optimize, and qualify methods in preparation for execution to assess safety and quality of vaccine candidates.
o Work together with other Analytical Department teams to determine the quality control strategy and identify resources for method development. Support for validation activities and impact assessments.
o Streamline workflows related to method development, qualification, training, transfer, and comparability.
o Serve as a subject matter expert for molecular methods. Provide Regulatory support.
o Support new technology assessment and licensing activities.
o Prioritize the deliverables from multiple programs and competing interests
We are looking for professionals with these required skills to achieve our goals:
o PhD or Master Degree with 5+ years’ industry experience in biology, biochemistry, pharmaceutical science related fields
o Experience with nucleic acid analysis and wet lab experience with molecular biology and biochemistry techniques;
If you have the following characteristics, it would be a plus:
o Working experience with gene therapies or specifically mRNA based vaccines or therapeutics;
o Experience with analytical assay development, including release assay, characterization assay, GMP testing in industry settings;
o Experience or knowledge of working in an environment under regulatory compliance;
o Industry experience relevant to molecular testing and diagnostics;
o Experience with PCR, Real-time PCR, digital PCR, DNA and RNA isolation, DNA cloning, molecular probe techniques
o NGS sequencing experience with bioinformatics knowledge and skills is appreciated;
o Research experience in RNA biology field;
o Experience with nucleic acid formulation and bioprocess development.