Senior Scientist – Biologics Analytical Research & Development
| Company | MSD |
|---|---|
| Location | Linden, NJ, USA |
| Salary | $114700 – $180500 |
| Type | Full-Time |
| Degrees | Bachelor’s, Master’s, PhD |
| Experience Level | Senior, Expert or higher |
Requirements
- Ph.D. in analytical chemistry/biochemistry or related field or M.S. with a minimum of 5 years of experience in the Pharmaceutical Industry or B.S. with a minimum of 8 years of experience in the Pharmaceutical Industry
- Strong background and experience in separations science
- Extensive experience with UPLC/HPLC analysis of biologics (e.g., SEC, RP, IEX) and CE techniques
- Experience in process- or impurity-related residual assay development
- Background in Analytical Methodologies and sound scientific understanding of Critical Quality Attributes/QbD/DOE principles as well as data analysis and statistics for setting specifications or related
- Ability to design, execute and development of methods for release, characterization, and stability testing of clinical trial material and in support of product and process development
- A strong team player with excellent oral and written communication skills; ability to work both independently for development of assays and cross-functionally for successful transfer of assays. Plan assay optimization and documentation to meet program deadlines
- Authoring and reviewing internal technical reports, sections of regulatory filings (e.g., IND, BLA) and external scientific publications
- Strong ability to deliver complex objectives under aggressive timelines in a rapidly changing environment
- Demonstrated scientific ability through publications and presentations in scientific conferences.
Responsibilities
- Development, qualification, implementation, troubleshooting and transfer of analytical methods for monoclonal proteins or other complex therapeutic proteins.
Preferred Qualifications
- Experience with qualification, validation, and transfer of assays to a GLP or regulated laboratory environment as listed in ICH Q2 and USP
- Experience in representing analytical functional area on project teams
- Strong knowledge of protein structure and degradation pathways
- Mass spectrometry for large molecules
- Molecular biology (PCR, DNA extraction) and immunoassay (ELISA, gel electrophoresis) techniques
- Experience in analysis of various Biologic modalities (e.g., mAb, antibody-drug conjugate, fusion protein)