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.
The successful candidate will be responsible for analytical method developments 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 improvement of analytical methods, which include, but are not limited to mass spectrometry, HPLC, and CE. The candidate is expected to design, execute and manage laboratory studies for supporting process development, clinical trial and product license application.
- Develop and optimize HPLC, CE, LC-MS and other protein analytical methods to support structural elucidation and physicochemical characterization of biopharmaceutical products.
- Serve as technical resource for analytical method development, transfer, data interpretation, method troubleshooting and improvements.
- Conduct studies in-house to increase the understanding of candidate molecules, works closely with cell line, cell culture, purification, conjugation, formulation and device development groups and support the process development activities.
- Prepare and review QC SOPs, protocols, and reports related to product release, stability study, method validation, etc.
- Conduct developability study and collaborate with research colleagues on transition of new molecules to CMC development.
- 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
- PhD or MS Degree in Chemistry, Biochemistry, Analytical Chemistry, or a related scientific field.
- Preferred qualification 3+ years of relevant experience with PhD or 10+plus years of relevant experience with MS.
- Extensive hands-on experience in protein analytical methods such as HPLC (SEC-, RP-, IEX-, HIC-, HILIC-), CE (CE-SDS, icIEF, CZE).
- Extensive Experience with LC-MS analysis of peptides and proteins.
- Detail-oriented and capable of identifying and solving complex scientific problems.
- Ability 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.
- Good multi-tasking, time management and organizational skills are essential.
- 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.
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?
Check out our landing page for more information on our BPD group https://careers.astrazeneca.com/bpd
Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/
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AstraZeneca has taken critical steps to protecting colleagues, loved ones, and patients from COVID-19 and its variants. COVID-19 vaccination is required for all US employees, and weekly PCR COVID-19 testing is required for those who are unvaccinated or have an approved accommodation.
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