Senior Scientist, Bioanalytical Development
Moderna Therapeutics is the first biopharmaceutical company dedicated to the discovery and development of a new class of drugs, NativeTM proteins therapeutics. Leveraging the natural way in which proteins are made by humans, our proprietary modified messenger RNA (mRNA) enables the patient’s protein translation machinery to synthesize therapeutics without inducing an innate immune response. This approach envisions dosing a patient with stable, modified RNA that encodes a therapeutic protein of interest, that upon translation in a cell type, results in therapeutic treatment with high efficacy, low immunogenicity, and more biologically relevant dosing. The technology alleviates the need for laborious and expensive in vitro tissue culture or protein manufacture and purification. Our manufacturing process is cell-free. The technology is therefore a quantum advance in the field of drug development with great promise for novel ways of treating disease with direct application in the worldwide market of therapeutic biologics, which includes peptides, proteins, and antibodies. We are looking for smart, committed individuals who are looking to change the world by bringing new drugs to patients.
TheBioanalytical development senior scientist will be an integrated member of the Chemistry Manufacturing and Controls (CMC) group whose work enables process development, formulation development, QC testing of products, and providing key information in support of CMC regulatory submissions.
- Lead development and qualification of bioassay based analytical methods for raw material, in-process, release, and stability testing of biopharmaceuticals
- Support of process development and analytical transfer to QC or CRO for clinical-phase GMP testing
- Lead product and impurity characterization, balancing in-house and external capabilities, and interfacing with contract organizations and collaborators
- Deliver technical reports and documents in preparation for Phase I/II regulatory submissions
- In-depth and hands-on industry experience with development of a broad range of bioanalytical and bioassay methodologies for evaluation of biological macromolecules (proteins, DNA, RNA), and their formulations
- Demonstrated success in transferring robust bioassay based analytical methods and creatively delivering analytical solutions for elucidation of structure and trace impurity identification generated during manufacture of complex molecules
- Technical skills include: protein chemistry, primary and transformed cell based bioassays and immunoassays, mass spectrometry, PCR, DNA/RNA analysis, and biophysical technologies
- Familiarity with ICH and regulatory guidelines as applied to analytical aspects
- Ph.D. with 5+ years or MS with 9+ years relevant experience
- Learning agility, critical thinking, and drive to bring innovation and efficiency to meet company objectives
- Effective in teamwork, clear verbal and written communication, skilled and efficient report writer
- Ability to prioritize in a fast pace environment