Director, Analytical Development, Viral Vector Product Development

This position will play a key role in Alexion’s Viral Vector Analytical Development team, interacting with the Genomic Medicine and Product Development Clinical Supply teams. Leading the analytical testing strategy for recombinant adeno-associated viral (rAAV) vectors, the Director implements pioneering analytics and automation to elevate testing capabilities. A critical aspect of the role will be the technical mentorship and management of the process analytics team in the performance of rAAV sample testing to support research and development functions to ultimately advance Alexion’s growing portfolio of genomic medicines.

Accountabilities

• Develop the analytical release, stability, and characterization testing strategy for the AAV product portfolio across the product lifecycle
• Collaborate with research and development teams to develop phase-appropriate analytical testing plans
• Lead a team of analysts in the performance of routine assays to support the testing of rAAV vectors (qPCR, ddPCR, ELISA, HPLC, CGE)
• Lead all aspects of testing of in-process and final samples to determine viral vector product quality
• Provide technical and strategic mentorship in the analytical methods used for product characterization and release testing
• Manage reference material lay down, qualification, and tracking
• Further optimization of existing assays and workflows and implementation of automation for improved assay performance and sample throughput
• Coordinate sample submission, data review, and dissemination for outsourced analytical testing (research and development samples)
• Assist the operations team with assay tech transfer to external partners and with problem-solving for any unexpected results in QC
• Provide support with regulatory filings, authoring of technical reports, and delivering scientific presentations summarizing data

Essential Skills/Experience

• MS or PhD in Cell Biology, Biochemistry, Molecular Biology, or related field
• 10+ years of industry experience in CMC analytics
• 2-3 years managerial experience
• Experience testing and developing assays for AAV or viral vectors, including the performance of routine biological assays including qPCR, ddPCR, ELISA, CGE and HPLC methods
• Technical and practical knowledge of regulatory guidance for development of genetic medicines and previous experience in supporting regulatory submissions (pre-IND, IND, BLA)
• Strong analytical approach and critical thinking skills
• Prior team leadership experience, including significant organizational, mentor, and communication skills
• Excellent interpersonal and collaborative skills, and the ability to work independently and effectively in a highly dynamic environment
• The duties of this role are generally 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

• Self-starter, comfortable with autonomy, and embrace opportunities to develop new genomic medicines as part of a dynamic team within Alexion!

When we put unexpected teams in the same room, we fuel 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 Alexion, AstraZeneca Rare Disease, you will grow and innovate within a rapidly expanding portfolio. Enjoy the entrepreneurial spirit of a leading biotech while meeting the needs of some of the most under-served patients globally. Our culture is rooted in integrity, inclusiveness, and dedication to supporting our communities. Here, 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!

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.