Development Scientist III, Protein Characterization

Introduction to role

As a Scientist III, you will lead protein characterization, product CQA assessment, and comparability studies. You will collaborate cross-functional teams, drive communications with collaborators, lead troubleshooting and investigations, provide subject matter expertise for regulatory interactions, and lead CMC analytical development activities as the analytical lead for therapeutic protein projects.

Accountabilities

• Leading and performing comparability and forced degradation studies.
• Leading and performing protein variant (e.g., charge and size) enrichment, fractionation, and characterization.
• Participate in cross-functional development teams representing the Protein Characterization group and lead scientific/technical problem-solving efforts with the group.
• Authoring CMC sections for regulatory, technical reports, department-specific protocols and reports, and general operating procedures. Leading the development and authoring of new procedures and work practices.
• Lead innovative technology evaluation and independently developing protein characterization strategies.
• Conduct experimental studies to develop, and optimize analytical/characterization methods for biotherapeutic candidates.

Essential Skills/Experience

• MS degree in Chemistry, Biochemistry, or related field with 10+ years of Industry experience or Ph.D. degree in Biochemistry or related field with 6+ years of Industry experience
• Extensive experience in separations science (e.g., SEC, RP, IEX, HIC, CE-SDS, and cIEF).
• Extensive experience in protein size and charge variants identification and product quality attribute severity assessment.
• Planning and organizing skills to plan, implement, and track commitments of the laboratory and to adjust to changing priorities.

Desirable Skills/Experience

• Experience in CMC development activities and previous experience as project lead for analytical function.
• Experience in characterization of various biologic modalities (e.g., mAb, multi-specifics, fusion protein, enzyme).

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 we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of four 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.

At AstraZeneca's Alexion division, we are driven by a mission to serve patients with rare diseases. Our work is led by their lived experiences, driving what we do and how we do it. We know our patients by name and meet their families.

Our culture is built on curiosity, co-creation, attentiveness, and a razor focus on their needs so we can tackle the toughest challenges for them. Here, you will grow and innovate within a rapidly expanding portfolio while enjoying an entrepreneurial spirit and autonomy. Join a supportive community where your career is not just a path but a journey to making a difference where it truly counts.

Ready to make an impact? Apply now to join our team!

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.