Formulation Development Lead

1 week ago


Gaithersburg, Maryland, United States Fladger Assoc. Inc. Full time
Job Title: Senior Scientist

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.
Requirements:
  • 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.
Estimated Salary:

$120,000 - $180,000 per year, depending on qualifications and experience.



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