Fladger Assoc. Inc.
Contract Duration: 12-36 months
- 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
Over a month ago
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