Development Scientist III, Viral Vector Analytical Development Full-time

Development Scientist III in Viral Vector Analytical Development

Are you ready to make a significant impact in the field of genomic medicine? As a Development Scientist III in Viral Vector Analytical Development at Alexion, you will be at the forefront of advancing our genomic medicine portfolio. Collaborate with a dynamic team of scientists and engage with the Genomic Medicine and Viral Vector Product Development groups to develop and optimize methods for assessing recombinant Adeno-Associated Virus (rAAV) viral vectors. Your expertise will drive innovation and contribute to regulatory submissions, ensuring the success of our cutting-edge therapies.

Accountabilities:

1. Develop, optimize, and implement biochemical and biophysical methods to quantify product and process impurities and perform extended protein characterization of rAAV vectors.
2. Design and execute experiments, review and analyze data, and qualify assays in lab activities.
3. Support tech transfer of biophysical assays to internal teams and external manufacturing/testing organizations for release and characterization testing; serve as subject matter expert for assay troubleshooting and lab investigations.
4. Develop presentations for internal and external audiences, author and review SOPs, technical reports, and assist with analytical sections for regulatory submissions (IND, BLA, etc.).
5. Serve as analytical lead on cross-functional CMC teams, collaborating with QC, Upstream/Downstream Process Development, Manufacturing, QA, and Regulatory teams to execute genomic medicine analytical strategy.

Essential Skills/Experience:

• BS in Molecular Biology, Biochemistry, or related field with 10+ years of relevant experience, a MS with 8+ years of experience, or PhD with 4+ years of experience.
• Strong hands-on experience in the development, qualification/validation, and transfer of biochemical and biophysical (liquid chromatography, dynamic and multi-angle light scattering, capillary gel electrophoresis, imaged capillary isoelectric focusing) methods for assessing viral vectors and/or rAAV products. Prior experience with mass spectrometry, surface plasmon resonance, mass photometry, analytical ultracentrifugation or other extended protein characterization techniques is a plus.
• Demonstrated ability to utilize standard office software (Excel, PowerPoint, Word, etc.), data analysis software (Chromeleon, Empower, OpenLab, JMP, etc.), and eNotebooks software.
• Strong analytical mindset and problem-solving skills.
• Superior organizational and time management skills, ability to prioritize multiple demands and work efficiently with great attention to detail.
• Excellent interpersonal and collaborative skills, and the ability to work independently and effectively in a highly dynamic environment.
• The duties of this role are conducted in a mixed office and lab environment. As is typical of a lab-based role, employees must be able, with or without an accommodation to: lift 15 pounds unassisted; work comfortably in a controlled environment with and around biological, infectious, and hazardous materials; gown/degown PPE; use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

Desirable Skills/Experience:

• Candidates should be self-starters, comfortable with autonomy, and embrace opportunities to develop new genomic medicines as part of a dynamic team within Alexion.

At AstraZeneca's Alexion division, you'll find an environment where innovation thrives. Our commitment to rare diseases means your work will have a profound impact on patients' lives. With a rapidly expanding portfolio and an entrepreneurial spirit, you'll be part of a team that values connection and collaboration. We empower our employees through tailored development programs that align personal growth with our mission. Join us in driving change with integrity while celebrating diversity and innovation.