Principal Scientist, External Viral Vector Testing

The Principal Scientist will overseeing external activities related to the release and stability of Alexion’s portfolio of AAV products. This includes managing relationships with contract manufacturing organizations (CMOs) and contract testing organizations (CTOs), ensuring compliance with regulatory standards, and implementing robust quality control processes. The ideal candidate will have experience in QC management within the biopharmaceutical industry, particularly with AAV gene therapy products. This position will provide strong scientific leadership, mentorship for junior team members, and subject matter expertise including method suitability, qualification and validation, raw material testing and controls, and aseptic process assurance/microbiological control. The Principal Scientist will also lead timely risk identification, communication, and resolution and work in close collaboration with Process Development and Clinical Supply (PDCS), Alexion Operations, Quality (QA), Regulatory Affairs (RA), Analytical Development and Quality Control (ADQC), and internal and external Testing/Manufacturing sites.

Accountabilities

• Establishing and maintaining strong relationships with CMOs/CTOs and other external partners
• Leading all aspects of external QC activities related to AAV product release and stability testing, and reference material establishment and characterization
• Creating and submitting QC contracts and onboarding new suppliers
• Reviewing and approving QC-related documentation, including tech transfer protocol and reports, SOPs, test methods, qualification and validation protocols, and reports
• Facilitating stability storage, initiation, release, and testing at external vendors in coordination with the stability lead
• Analyzing release and stability data and trends to identify potential quality issues and implement corrective actions
• Managing specifications, shelf-life stability programs for AAV and AAV-related starting materials (plasmids, cell lines, etc)
• Communicating external QC related investigations and issues to analytical lead and CMC team lead in a timely fashion
• Co-authoring and reviewing IND/IMPD, BLA/MAA, and other technical documents for regulatory agency submissions
• This is a global role requiring domestic and international travel (~20%)

Essential Skills/Experience

• PhD in biochemistry, biological science, chemistry, or chemical engineering (or related fields) with 4+ years of relevant experience, or BS/MS with 8+ years of experience in biopharmaceutical organization with expertise in quality control, analytical development, and/or tech transfer
• Strong technical services experience including discrepancy resolution, OOS/OOT investigation, LIR investigation/resolution, shipping or storage deviations, root cause analysis, CAPA implementation, and analytical control data monitoring for internal and external facilities
• Experience with GxP Change Control (shelf-life extension, specification revisions, and other changes required to support innovative programs or program progression through different phases of development)
• Experience with development or implementation of AAV viral vector and/or plasmid DNA methods in a GxP setting with ability to present and defend technical aspects of assay qualification and validation during regulatory agency inspections and/or queries
• Comprehensive understanding of cGMP/ICH requirements for clinical and commercial biopharmaceuticals
• Strong project leadership and resource management skills along with good people, verbal, and communication skills. Ability to support development of aggressive but achievable project plans to ensure effective, timely execution and lead by influence both internal and external team members.

Desirable Skills/Experience

• Knowledge in planning for program advancement to analytical validation and commercial launch, with experience supporting teams through BLA approvals
• Expertise in raw material or microbiological control strategy
• Capability to analyze data using basic statistical methods using tools such as JMP and present comparability analysis in evidence of effective transfer
• Knowledge of quality attribute measurement assays and application to troubleshooting product quality related discrepancies
• Structured problem-solving experience

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, you will find an environment where work is more than just a job. We are driven by our mission to transform the lives of patients living with rare diseases. Our entrepreneurial spirit combined with the resources of a global pharma company creates a unique space where innovation thrives. You will be part of a supportive community that values diversity, encourages new ideas, and fosters personal growth. Here, your contributions make a real impact on patients' lives.

Ready to make a difference? 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.