Senior Scientist

Responsibilities:

• 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.

Experience:

• 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.