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Scientist III, Analytical Development and Clinical QC

Alexion Pharmaceuticals, Inc. · New Haven, CT · 1 wk ago
AnalystFull-time

About the role

As a Scientist II in Analytical Development and Clinical QC at Alexion, you'll be at the forefront of our Late-Stage Analytical team! This pivotal role demands analytical expertise and a proven track record in managing analytical development projects throughout the CMC lifecycle. You'll prioritize multiple projects, collaborating closely with PDCS teams, Regulatory, QA, and external QC laboratories. Develop and implement late-stage analytical strategies, including method transfer, validation, and verification, while authoring regulatory filings with a keen understanding of country-specific requirements. As the analytical functional lead for clinical CMC programs, you'll drive end-to-end analytical activities from Phase 3 through commercialization.

Responsibilities

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

Requirements

  • 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 (e.g., 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 clear reports, regulatory submissions, and presentations to technical and non-technical collaborators
  • Demonstrated success in method development, qualification/validation (per ICH Q2), transfer to QC/CMOs, and continued verification for commercial control strategies
  • Strong command of ICH (Q5E, Q6B, Q8–Q12), USP/EP, FDA/EMA expectations for biologics, GMP/GLP compliance, and authoring/reviewing CTD Module 3, IND/IMPD, BLA/MAA analytical sections and responses to agency queries
  • Proficiency with GxP compliant documentation, ALCOA+ data integrity principles, OOS/OOT handling, deviation/CAPA management, and audit readiness
  • Ability to define critical quality attributes (CQAs build specifications, and implement commercial control strategies aligned with Quality by Design (QbD)

Qualifications

  • Able to lift/carry 15/30 pounds unassisted/assisted
  • Comfortable in a controlled environment with and around biological, infectious, and hazardous materials
  • Familiar with gown/degown PPE
  • Proficient with GxP compliant documentation, ALCOA+ data integrity principles, OOS/OOT handling, deviation/CAPA management, and audit readiness
  • Ability to define critical quality attributes (CQAs build specifications, and implement commercial control strategies aligned with Quality by Design (QbD)

Skills

  • 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 (e.g., 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 clear reports, regulatory submissions, and presentations to technical and non-technical collaborators
  • Demonstrated success in method development, qualification/validation (per ICH Q2), transfer to QC/CMOs, and continued verification for commercial control strategies
  • Strong command of ICH (Q5E, Q6B, Q8–Q12), USP/EP, FDA/EMA expectations for biologics, GMP/GLP compliance, and authoring/reviewing CTD Module 3, IND/IMPD, BLA/MAA analytical sections and responses to agency queries
  • Proficiency with GxP compliant documentation, ALCOA+ data integrity principles, OOS/OOT handling, deviation/CAPA management, and audit readiness
  • Ability to define critical quality attributes (CQAs build specifications, and implement commercial control strategies aligned with Quality by Design (QbD)

Benefits

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.

Pay

Competitive salary commensurate with experience

Schedule

Flexible schedule with a minimum of four days per week in the office, with the option for remote work.

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