SUMMARY OF THE GROUP:

As a part of Biopharmaceutical Development, the Late-Stage Formulation Sciences group, within the department of Dosage Form Design and Development, is on a mission to develop extraordinary products through excellent science, forward-thinking execution, and compassion for patients and those who touch our products. We develop and characterise intended commercial formulations and finished dosage forms to deliver high quality biologics to the market for patients. We develop robust formulations, Drug Products, and product control strategies to ensure approval of marketing applications for product commercialization and launch.
The Late-Stage Formulation Sciences (LSFS) 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.

REQUIRED SKILLS:

• Hands-on experience with biological characterization methods including analytical and biophysical techniques - high-performance size exclusion chromatography (HPSEC), particle characterization and sizing (e.g. light obscuration, micro-flow imaging), and aggregate characterization methods.
• Bachelor’s degree with demonstrated ability OR Master’s degree with 2+ years of experience.
• Experience with protein formulation and drug product development. In depth knowledge of protein biochemistry and degradation pathways.
• Effective interpersonal skills to work in teams and to present complex scientific concepts.
• Ability to work independently and to influence team decision-making.
• High degree of self-motivation and commit to results.

DESIRED SKILLS:

• Understanding of clinical dosage preparation and administration practices is highly desired.
• Knowledge of risk assessment methodologies and CMC regulatory guidance is a plus.
• Skills leading, planning, and implementing complex projects on tight timelines are important.
• Experience with study design (Design of Experiment) and statistical data analysis using JMP or Minitab software is highly desired.

ABOUT THE ROLE:

Do you have a passion for Science? Would you like to apply your expertise to impact a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!
At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.

MAIN DUTIES & RESPONSIBILITIES:

• Laboratory-based position responsible for independently designing and implementing experiments for late-stage formulation development of biologics, including product characterisation, stability, and in-use compatibility studies
• Exercise technical discretion and scientific difficulty in experimental protocol design, data analysis, and results interpretation
• Develop new methods, technologies, and approaches as needed to advance projects to BLA submission and approval
• Effectively present findings in departmental and inter-departmental meetings and prepare technical reports