Scientist III, Analytical Development and Clinical QC

Responsibilities

• Lead analytical method validations, transfers, and compendia method verifications across all stages of clinical development.
• Serve as the analytical functional lead for late-stage CMC programs, driving end-to-end activities from Phase 3 through commercialization.
• Develop and implement analytical strategies, including control strategies, lifecycle management, and QC testing oversight.
• Oversee analytical QC testing, troubleshoot technical issues, and conduct data analysis to ensure program health.
• Author regulatory submissions (CTD Module 3, IND/IMPD, BLA/MAA) and respond to health authority queries.
• Collaborate cross-functionally with PDCS, Regulatory, QA, and external QC laboratories/CMOs.

Requirements

• PhD or MSc in Biochemistry, Analytical Chemistry, Molecular Biology, Pharmaceutical Sciences, or a related field.
• 4+ years of progressive experience in biologics analytical development across clinical and commercial stages.
• Technical expertise in chromatography (SEC, RP, IEX), capillary electrophoresis (CE-SDS, cIEF), spectroscopy, and bioassays.
• Strong knowledge of ICH (Q5E, Q6B, Q8–Q12), USP, EP, and FDA/EMA regulations for biologics.
• Proven experience in method development, qualification/validation (per ICH Q2), and transfer to QC or CMOs.
• Proficiency with GxP documentation, ALCOA+ data integrity principles, and deviation/CAPA management.

Preferred Qualifications

• Experience leading CDMO/CRO analytical activities, including routine testing oversight and investigations.
• Background in Quality by Design (QbD), Design of Experiments (DOE), and statistical data analysis.
• Experience with ICH stability programs (Q1), shelf-life modeling, and forced degradation studies.
• Familiarity with digital laboratory systems such as LIMS, ELN, and Chromatography Data Systems.
• Expertise with statistical software such as JMP or AI-driven analytical tools.

About the Company

Alexion, an AstraZeneca company, is dedicated to transforming the lives of patients living with rare diseases. We combine an entrepreneurial biotech spirit with the global resources of AstraZeneca to drive innovation and deliver life-changing medicines.