Senior Scientist
2 weeks ago
Title: Senior Scientist, Late-Stage Formulation Sciences
Location: The Discovery Centre, Cambridge, UK
Hybrid Working: 3 days on-site/ 2 days remote
Duration: 39 weeks
IR35 Determination: Inside
Business Area:
The Late-Stage Formulation Group is responsible for development of intended commercial formulations to advance AstraZeneca’s 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.
Job Description/Position Summary:
Scientific position responsible for Late-Stage formulation development of biologic products. Design and execute formulation risk assessments and characterization studies and develop 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. Exercise technical discretion and scientific rigor in experimental protocol design, data analysis, and results interpretation. Author marketing applications and support regulatory responses to approval. Develop new strategies and approaches to advance Late-Stage formulation development and deliver scientific and operational objectives.
Position Requirements/Skills and Abilities:
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. High degree of self-motivation and drive for results are critical.
Education Requirements:
B.S. in chemistry, biochemistry, pharmaceutical sciences, engineering, applied sciences, or related field with a minimum of 8+ years of experience, M.S. with a minimum of 6+ years of experience, or Ph.D. with 0+ years of experience.
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