Scientist III, Analytical Development and Clinical QC

AstraZeneca•New Haven, CT

4d•Onsite

About The Position

As a Scientist III 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. When we put unexpected teams in the same room, we fuel ambitious thinking with the power to encourage 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 outstanding and ambitious world. At AstraZeneca's Alexion division, your work is more than just a job - it's a mission to transform lives. Our dedication to patients drives everything we do. With a rapidly growing portfolio and entrepreneurial spirit akin to a leading biotech company, you'll thrive in an environment that develops innovation and growth. Here you'll find an encouraging community of leaders and peers dedicated to making a difference for those living with rare diseases. Your career journey will be enriched by tailored development programs that align your growth with our mission. Ready to make an impact? Apply now to join our team!

Requirements

PhD in Biochemistry, Analytical Chemistry, Molecular Biology, Pharmaceutical Sciences, or related field with 6+ years experience
MSc in Biochemistry, Analytical Chemistry, Molecular Biology, Pharmaceutical Sciences, or related field with 10+ years experience
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)
The duties of this role are generally conducted in a lab environment. As is typical of a lab-based role, employees must be able, with or without an accommodation to: lift/carry 15/30 pounds unassisted/assisted; 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.

Nice To Haves

Background in analytical method development and sound scientific understanding of Critical Quality Attributes/QbD/DOE principles as well as statistical data analysis and relevant tools
Leading all aspects of CDMO/CRO analytical activities including routine testing oversight, troubleshooting and investigations and method qualification, validation, and transfer.
Experience in country specific compendia requirements and knowledge of CHP
Experience in ICH stability programs (Q1), shelf-life modeling and projections and related statistical approaches
Experience in extended characterization and comparability including forced degradation studies for process comparability and life cycle management.
Digital laboratory systems and automation: Familiarity with LIMS, ELN, Chromatography Data Systems, data visualization, and automation/robotics in analytical workflows
Expertise with AI tools and statistical software, for example jmp

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.

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