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Senior Scientist

Fladger Assoc. Inc.
Gaithersburg, MD
  • Full-Time
Job Description
Gaithersburg, MD
Contract Duration: 12-36 months
Rate: Negotiable


  • Excellent employment opportunity for a Senior Scientist in the Gaithersburg, MD area.
  • The Late-Stage Formulation Sciences Group is responsible for development of intended commercial formulations to advance the late-stage biologics portfolio, and the life cycle management of commercialized products.
  • The group plays an integral part in the design and development of patient centric drug products.
  • This is a Scientific position, and the incumbent will be responsible for late-stage formulation development of biologic products.
  • Will be involved in the design and execution of formulation risk assessments and characterization studies, and development formulation control strategies for Drug Substance and Drug Product.
  • Ensure robustness of intended commercial formulations, suitability for intended use of container closure/packaging systems, and in-use compatibility with clinical administration components.
  • Expected to exercise technical discretion and scientific rigor in experimental protocol design, data analysis, and results interpretation.
  • Other responsibilities include authoring of marketing applications and provision of 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, 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.


Fladger Assoc. Inc.

Gaithersburg, MD
20878 USA



Posted date

Over a month ago

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