Lead Analytical Scientist - Biologics (Late-Stage)

BioCT Innovation Commons; New Haven, Northern (CT, KY); Hybrid; USD 120,000 - 180,000; Full time

Job summary

Alexion in New Haven, CT, seeks an experienced Scientist II in Analytical Development and Clinical QC to lead late-stage analytical strategies through Phase 3 and commercialization. Expect method transfer, validation, and regulatory filings, with cross-functional collaboration across PDCS, Regulatory, QA, and external labs.

The role requires 4+ years in biologics analytical development and strong expertise in chromatography, CE-SDS, cIEF, bioassays, and impurity testing.

Qualifications

• Advanced degree (PhD or MSc) in Biochemistry, Analytical Chemistry, Molecular Biology, Pharmaceutical Sciences, or related field
• 4+ years of progressive experience in biologics analytical development across clinical and commercial stages
• Proven hands-on strategic and technical expertise with monoclonal antibodies, bispecific, fusion proteins
• Technical expertise in chromatography (SEC, RP, IEX), capillary electrophoresis (CE-SDS, cIEF), spectroscopy (UV/Vis, fluorescence, CD), bioassays (binding, potency), and residuals/impurities testing (HCP, DNA, residual Protein A)
• Compendia method experience with a focus on USP, EP and JP compliance
• Strong written and verbal skills for reports, regulatory submissions, and presentations
• Demonstrated success in method development, qualification/validation (ICH Q2), transfer to QC/CMOs, and continued verification for commercial control strategies
• GxP documentation, ALCOA+ data integrity, OOS/OOT handling, deviation/CAPA management, and audit readiness
• Ability to define CQAs and implement commercial control strategies aligned with QbD

Responsibilities

• Lead all aspects of analytical method validations, transfers, and compendia verifications across clinical development and life-cycle stages
• Serve as analytical lead for CMC programs, focusing on late-stage programs with cross-functional collaboration
• Develop and implement end-to-end analytical strategy for key late-stage biologics programs, including control strategy and QC oversight
• Lead analytical QC testing, troubleshooting, and data analysis to ensure program health and identify risks
• Author regulatory submissions for clinical and commercial markets and respond to agency queries

Skills

Analytical development

Biologics expertise

Monoclonal antibodies

QC/CMO transfer

CTD/regulatory submissions

Education

PhD or MSc in Biochemistry/Analytical Chemistry

Tools

LIMS

ELN

Chromatography Data Systems

JMP

Job description

Alexion in New Haven, CT, seeks an experienced Scientist II in Analytical Development and Clinical QC to lead late-stage analytical strategies through Phase 3 and commercialization. Expect method transfer, validation, and regulatory filings, with cross-functional collaboration across PDCS, Regulatory, QA, and external labs.

The role requires 4+ years in biologics analytical development and strong expertise in chromatography, CE-SDS, cIEF, bioassays, and impurity testing.