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.

About AstraZeneca in Gaithersburg, MD:

Our Gaithersburg, Maryland facility creates life-changing medicines for people around the world.  This campus employs more than 3,500 experts in our field and is only a short drive from Washington, DC. This modern and vibrant scientific campus is the home of R&D and Oncology in the US. Here, we play host to some of the most cutting-edge technology and lab spaces, all designed to inspire collaboration and cross-functional science. We believe employees benefit from being challenged and inspired at work. We are dedicated to creating a culture of inclusion and collaboration.

The Gaithersburg site offers a variety of amenities to help boost productivity and help keep our employees happy and healthy. This includes a fitness center, employee healthcare clinic, electric vehicle charging stations, dry cleaning, full-service cafeteria and copy center. This is where you’ll find newly-designed, activity-based work spaces to suit a variety of working styles while increasing collaboration between teams. 

Summary of the group:

In Purification Process Sciences in Gaithersburg, MD you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives.  We’re constantly pushing the boundaries of science to deliver life-changing medicines to patients, with a passion for discovery and a pipeline to show for it. We’re pioneering innovative research and exploring novel pathways across key therapeutic areas including oncology, respiratory, inflammation and autoimmunity, cardiovascular and metabolic disease, and infection and vaccines. And we’re industry-leading in immunology, protein engineering and translational science. We offer a unique and strong collaborative network as part of the AstraZeneca family, as together we explore synergies between small and large molecules.

Key Responsibilities:
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 and 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 and troubleshooting and resolution of deviations in GMP manufacturing processes.
o Evaluate of new technologies to facilitate process development.

Requirements:

Bachelor's or Master's Degree in Biochemistry, Chemical Engineering, or related field.
 

A minimum of a Bachelor'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)

Date Posted

Closing Date

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 authorization and employment eligibility verification requirements.