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Scientist I / II - Physiochemical Development

Location Gaithersburg, Maryland, United States Job ID R-093623 Date posted 11/20/2020

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. 

Position Summary:

The candidate will be responsible for analytical method development and structure characterization of biopharmaceutical products, such as novel therapeutic proteins, peptides, monoclonal antibodies, antibody-drug conjugates, bispecific antibodies, fusion proteins, mRNA, DNA. She / he will lead the structure characterization, development and optimization of analytical methods, which include, but are not limited to HPLC and CE. The candidate is expected to design, execute and manage laboratory studies to support process development, clinical trial and product license application.

Primary Responsibilities

  • Develop and optimize HPLC, CE, and other protein analytical methods to support structural elucidation and physicochemical characterization of biopharmaceutical products.
  • Apply mass spectrometry-based approaches, including peptide mapping, disulfide bond mapping, intact mass, N-/O-linked glycosylation profiling, de novo sequencing to support product characterization.
  • Keep accurate records of all experiments, data, equipment logs and troubleshoot the instruments as necessary
  • Present and discuss experimental results at group/project team meetings
  • Prepare and review QC SOPs, protocols, and reports related to product release, stability study, method validation, etc.
  • Serve as technical SMEs for analytical method development, transfer, data interpretation, method troubleshooting and improvements.
  • Collaborate with cell line development, upstream, downstream formulation and device development groups to support process development activities.
  • Author and review CMC sections related to analytical procedures, method validation, specifications, reference standard and stability in regulatory submissions.
  • Publish/present in high quality journals/conferences         


Education & Experience Requirements:

PhD, MS or BS in analytical science, chemistry, biochemistry or related fields, with an emphasis on protein separation or mass spectrometry strongly preferred

Scientist I:

- PhD with some relevant experience preferred or a Masters and a minimum of 8 years of relevant experience or a BS and at least 10 years of relevant experience

- 5+ years of hands-on experience of utilizing separation or mass spectrometry-based techniques for protein analysis and characterization

Scientist II:

- PhD with at least 3 years of relevant experience or Masters and a minimum of 10 years of relevant experience or a BS and at least 13 years of relevant experience

- 5+ years of hands-on experience of utilizing separation or mass spectrometry-based techniques for protein analysis and characterization

Required Skills:

  • Trained in separation science or mass spectrometry with fundamental understanding of protein analysis and characterization.
  • Extensive hands-on experience with method development, application, and instrument maintenance
  • Strong scientific skills including sound experimental design, data processing and interpretation
  • Self-motivated and able to work independently in a fast-paced environment and drive multiple projects simultaneously.
  • Strong interpersonal skills and excellent oral and written communication skill a must.
  • Experience in cGMP (such as document management, deviation root-cause analysis, CAPA and change control) and QC practices including reference standard, control chart, stability, IOQ and validation is a plus.
  • Strong understanding in statistical analysis related to method development is a plus.

Why AstraZeneca?

At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognising their potential. Join us on our journey of building a new kind of organisation to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey.

So, what’s next!

Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available and we hope it’s yours.

Where can I find out more?

Our Social Media, Follow AstraZeneca on LinkedIn

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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.

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Great culture, great work assignments, supportive management. Rotation opportunity within the company. They value inclusion and diversity.