Associate Principal Scientist β Materials and Biophysical Characterization (biotherapeutics)
Responsibilities:
- Develop and implement biophysical and particle characterization tools.
- Collaborate with process, formulation, and device functions as part of the CMC development team.
- Use scientific expertise to solve challenging biotherapeutics characterization problems requiring deep analytical insight.
- Author technical reports and regulatory documents; present technical data.
- Conduct independent research; publish and present at scientific conferences.
- Engage with external scientific societies/organizations and manage projects.
Minimum Education/Experience:
- Ph.D. in Biophysics, Biochemistry, Chemistry, Chemical Engineering, Biomedical Engineering, Pharmaceutical Sciences, or related discipline with 4+ years relevant industry experience; OR
- M.S. with 8+ years relevant industry experience.
Required Skills/Experience:
- Hands-on biophysical characterization of proteins/peptides (e.g., CD, IR, DSC, AUC).
- Biologics analysis, protein/peptide stability, and protein-protein interactions.
- Subvisible/submicron particle characterization (e.g., flow imaging microscopy, BMI, flow cytometry, DLS).
- Biological formulation and analytical method development.
- Understanding of protein aggregation mechanisms and links between analytical methodologies.
- Ability to deliver complex objectives under aggressive timelines; initiative, creativity, and innovative problem solving.
- Strong oral/written communication; ability to work independently and cross-functionally.
Preferred Skills/Experience:
- Lyophilized protein formulation characterization.
- Protein-interface interactions (e.g., interfacial rheology, QCMD).
- Combination products for protein therapeutic delivery (e.g., autoinjectors).
- Molecular modeling.
- Experience across biologics modalities (peptides, mAbs, ADC, fusion proteins).
Application:
- Apply via https://jobs.merck.com/us/en (application deadline stated on the posting).