Sr. Scientist - Analytical

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development, and commercialisation 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 AZ, we’re proud to have an exceptional workplace culture that encourages innovation and collaboration. Here, employees are empowered to express diverse perspectives – and made to feel valued, energized and rewarded for their ideas and creativity. AZ is a place where passionate people can immerse themselves in their work and make significant contributions to scientific excellence and medicines – does this describe a place where you would like to work?

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.

AstraZeneca has an opportunity for a Scientist in the Physicochemical Development Group within the Analytical Sciences Department in Gaithersburg, MD.

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.

SR. SCIENTIST - ANALYTICAL

Summary of the group

In this role, you will be responsible for analytical method development and structure characterization of biopharmaceutical products, such as monoclonal antibodies, antibody-drug conjugates, bispecific antibodies, and fusion proteins. You will independently design, develop and implement innovative separation and/or mass spectrometry-based methods to improve product understanding drive development decisions.

Primary Responsibilities

• Independently 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, sub-unit mass, and N-/O-linked glycosylation profiling to support product characterization.

• Serve as technical SMEs for analytical method development, transfer, data interpretation, method troubleshooting and improvements.

• Collaborate with broader analytical team including Bioassay, Process Analytics and Separations to characterize drug substance, drug product, and impurities.

• Collaborate with cell line development, upstream, downstream formulation and device development groups to support process development activities.

• Keep accurate records of all experiments, data, equipment logs and troubleshoot the instruments as necessary.

• Prepare and review method SOPs, protocols, and analytical development reports related to support product release, stability study, method validation, etc.

• Author and review CMC sections related to analytical procedures, method validation, specifications, reference standard and stability in regulatory submissions.

• Present and discuss experimental results at group/project team meetings.

• Engage and influence the broader scientific community through publications and poster and oral presentations at industry conferences.

Qualifications

Education & Experience Requirements:

Background in analytical science, chemistry, biochemistry or related fields, with an emphasis on protein separation or mass spectrometry strongly preferred.

• PhD with 0-5 years of relevant experience preferred or

• Master with a minimum of 8 years of relevant experience, or

• BS with at least 10 years of relevant experience

• 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.

• Proven record of advanced technical/scientific achievement and innovation.

• 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.

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn’t mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.