AstraZeneca Pharmaceuticals LP R&D Associate I/II in Gaithersburg, Maryland
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.
This position is a hands-on, laboratory-based role.
This role will:
Develop and characterize downstream processes for the manufacture of biopharmaceuticals (monoclonal antibodies and other proteins) in late stage clinical development through commercial launch.
Be responsible for a portion of a purification development project.
Make observations, analyze data and interpret results.
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/review development reports, tech transfer and process validation documents, regulatory submissions.
Support technology transfer to Clinical/Commercial Manufacturing facilities.
Support troubleshooting and resolution of deviations in GMP manufacturing processes.
Evaluate of new technologies to facilitate process development.
R&D Associate I requires a Bachelor's Degree with some relevant industrial experience preferred
R&D Associate II requires a Bachelor's Degree with 2+ years of relevant experience or a Masters and some industrial experience preferred
Education: Bachelor's Degree in Biochemistry, Chemical Engineering, or related field
Proficiency in protein purification principles and methods including (but not limited to) different modes of chromatography, viral removal/inactivation steps and filtration.
Knowledge of: o Basic protein chemistry; protein and analytical chemistry, process robustness concepts and process scale-up o Working knowledge of good laboratory practices o Purification process design o Basic analytical techniques for protein products (HPLC analysis, protein quantification methods, electrophoresis; etc.) o AKTA systems/software
Highly team-oriented, energetic, critical thinker, organized, capable of significant multitasking with excellent oral and written communication skills
Experience considered a plus: o Statistical design of experiments (DOE) o Process scale-up and technology transfer o cGMP manufacturing principles and environments o Process validation o Familiarity with risk assessments and Regulatory submissions (especially BLA) o Purification of protein-based therapeutics other than antibodies (eg. conjugates, bispecifics, fusion proteins or products produced by microbial systems)