Formulation Development Lead
1 week ago
We are seeking a highly skilled Senior Scientist to join our team at Fladger Assoc. Inc. in Gaithersburg, MD.
Job Summary:The selected candidate will be responsible for leading the development of late-stage formulations for biologic products. This includes designing and executing formulation risk assessments, characterization studies, and control strategies for Drug Substance and Drug Product.
About Us:Fladger Assoc. Inc. is a leading contract research organization dedicated to advancing the biopharmaceutical industry through cutting-edge scientific expertise and innovative solutions.
Key Responsibilities:- Lead late-stage formulation development of biologic products, ensuring robustness and suitability for intended use.
- Design and execute formulation risk assessments, characterization studies, and control strategies.
- Develop new strategies and approaches to advance late-stage formulation development and deliver scientific and operational objectives.
- Bachelor's, Master's, or Ph.D. in Chemistry, Biochemistry, Pharmaceutical Sciences, Engineering, or applied Sciences.
- Proven experience with high-performance size exclusion chromatography (HPSEC), particle characterization and sizing, and aggregate characterization methods.
- Strong understanding of protein biochemistry and degradation mechanisms, biopharmaceutical manufacturing processes, combination drug products, and/or biophysical analytical methods.
- Excellent leadership, planning, and execution skills for complex projects on tight timelines.
$120,000 - $180,000 per year, depending on qualifications and experience.
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