R&D Associate I/II, Purification Process Sciences
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.
R&D Associate I / II
Location: Gaithersburg, MD - Corporate Headquarters
* This role can be filled as R&D Associate I or R&D Associate II. Position is a hands-on, laboratory-based role.
* The successful candidate will:
o Develop and characterize downstream processes for the manufacture of biopharmaceuticals (monoclonal antibodies and other proteins) in late stage clinical development through commercial launch.
o Be responsible for a portion of a purification development project.
o Make observations, analyze data and interpret results.
o Maintain accurate records of experimental results, review, analysis, and interpretation of experimental data.
o Make periodic presentations in group meetings, project team meetings, and in one-on-one situations.
o Prepare/review development reports, tech transfer and process validation documents, regulatory submissions.
o Support technology transfer to Clinical/Commercial Manufacturing facilities.
o Support troubleshooting and resolution of deviations in GMP manufacturing processes.
o Evaluate of new technologies to facilitate process development.
Bachelor's or Master's Degree in Biochemistry, Chemical Engineering, or related field.
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 Master's Degree with some relevant industrial experience preferred
* 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 Working knowledge of AKTA systems/software and JMP 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 Mechanistic modeling of chromatography and other unit operations
o Purification of protein-based therapeutics other than antibodies (eg. conjugates, bispecifics, fusion proteins or products produced by microbial systems)
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.