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Senior Research Scientist
2 months ago
Fladger Assoc. Inc. is seeking a highly skilled Senior Research Scientist to join our team in the Gaithersburg area. This is a scientific position that requires expertise in late-stage formulation development of biologic products.
Key Responsibilities- Design and execute formulation risk assessments and characterization studies to ensure the robustness of intended commercial formulations.
- Develop formulation control strategies for Drug Substance and Drug Product, and ensure suitability for intended use of container closure/packaging systems.
- Exercise technical discretion and scientific rigor in experimental protocol design, data analysis, and results interpretation.
- Author marketing applications and provide support to regulatory responses to approval.
- Develop new strategies and approaches to advance late-stage formulation development and deliver scientific and operational objectives.
- BS, MS, or PhD in Chemistry, Biochemistry, Pharmaceutical Sciences, Engineering, or applied Sciences.
- Knowledge of protein biochemistry and degradation mechanisms, biopharmaceutical manufacturing processes, combination drug products, and/or biophysical analytical methods is required.
- Hands-on experience with high-performance size exclusion chromatography (HPSEC), particle characterization and sizing (e.g., light obscuration), and aggregate characterization methods are strongly preferred.
- Experience with formulation and biopharmaceutical development, characterization, control strategy, quality risk management, and/or CMC regulatory guidance and filings is preferred.
- Skills leading, planning, and executing complex projects on tight timelines are important.