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About the position
The Associate Principal Scientist in Biologics Analytical Research and Development is a laboratory-based role focused on solving complex analytical problems related to biologics drug substances and products. This position requires collaboration in a multidisciplinary team environment and involves the development, qualification, implementation, troubleshooting, and transfer of analytical methods for therapeutic proteins. The successful candidate will lead projects, benchmark techniques, and provide technical leadership in assay development and data interpretation.
Responsibilities
- Development of new assay platforms for biologics.
- Benchmarking current approaches/techniques to industry standards.
- Providing technical leadership in design of experiments and data interpretation.
- Leading small groups of technical personnel and analytical projects.
- Authoring and reviewing internal technical reports and regulatory filings.
- Planning assay optimization and documentation to meet program deadlines.
- Collaborating cross-functionally for successful transfer of assays.
Requirements
- B.S. in Chemistry, Biochemistry, Engineering, Pharmaceuticals, or related field with 10 years of relevant experience; or Master's degree with 7 years of relevant experience; or Ph.D. with 3 years of relevant experience.
- Strong background and experience in separations science.
- Extensive experience with UPLC/HPLC analysis of biologics.
- Experience with process- and impurity-related residual assay development using molecular biology and immunoassay techniques.
- Ability to design, execute and/or direct the development and qualification of assays for clinical trial material.
Nice-to-haves
- Understanding of protein degradation mechanisms.
- Experience with qualification, validation, and transfer of assays to a GLP or regulated laboratory environment.
- Experience in representing analytical functional area on project teams.
- Experience with complex glycan analysis and its link to mechanisms of actions.
- Experience in data analytics, programming, or laboratory automation.
Benefits
- Health insurance
- Paid holidays
- Retirement plan
