Scientist I, Purification Process Sciences at AstraZeneca in Gaithersburg, Maryland

Posted in Other 24 days ago.

Job Description:

AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines for some of the world's most serious diseases. But we're more than one of the world's leading pharmaceutical companies. At AstraZeneca, we're proud to have a unique workplace culture that inspires innovation and collaboration through scientific research. Here, employees are empowered to express diverse perspectives and are made to feel valued, energized and rewarded for their ideas and creativity.

Job Description

Position is a hands-on, laboratory-based role.

The successful candidate will:
  • Design, optimize, and characterize downstream processes for the manufacture of biopharmaceuticals (monoclonal antibodies and other proteins) in late stage clinical development, validation through commercial launch.
  • Be responsible for a significant portion of a purification development project.
  • Maintain accurate records of experimental results, review, analysis, and interpretation of experimental data.
  • Make periodic presentations in group meetings, project team meetings, and in one-on-one situations.
  • Prepare technical reports.
  • Support the preparation and review of regulatory documents such as BLAs.
  • Support technology transfer to Clinical/Commercial Manufacturing facilities.
  • Support troubleshooting and resolution of deviations in GMP manufacturing processes.
  • Evaluate new technologies to facilitate process development.

Position Requirements

This position requires a Ph.D. Degree in Biochemistry, Chemical Engineering, or related field.

Scientist I: PhD and some relevant experience preferred

Scientific and/or technical training in process chromatography, ultrafiltration / diafiltration, and other separations technologies is required.

Excellent oral and written communication skills are essential.

Special Skills and Abilities
  • Proficiency in protein purification principles and methods including (but not limited to) different modes of chromatography, viral reduction steps and filtration.
  • Knowledge of protein chemistry; protein and analytical chemistry, process robustness concepts and process scale-up
  • Strong technical writing skills
  • Knowledge of statistical design of experiments (DOE); proficiency with statistical software is preferred
  • Basic analytical techniques for protein products (HPLC analysis, protein quantification methods, electrophoresis; etc.)
  • Highly team-oriented, energetic, critical thinker, organized, capable of significant multitasking with excellent oral and written communication skills
  • Experience considered a plus:
    • Technical writing in regulatory documents for biopharmaceuticals
    • Working knowledge of AKTA systems/software and JMP software
    • cGMP manufacturing principles and environments
    • Quality by Design, risk assessment / prioritization
    • Machine learning and data mining
    • Mechanistic modeling of chromatography and other unit operations

Expected to be highly team oriented, organized, capable of significant multitasking, able to manage multiple projects with significant independence in a matrix organization, and possess excellent oral and writing skills.