Scientist I, Analytical Development and Clinical QC

AstraZeneca•New Haven, CT

1d•Hybrid

About The Position

Join the Late Stage Analytical team to advance biologics through late-stage clinical development and commercialization. The role provides analytical expertise and helps shape analytical strategies across the CMC lifecycle, with a focus on analytical method validation, verification, transfer, and lifecycle management. The Scientist leads strategies for validation, verification, and transfer of analytical and compendial methods supporting clinical and commercial biologics, and helps define analytical testing strategies throughout the product lifecycle. The role applies technical expertise to solve complex analytical challenges and ensure robust, phase-appropriate methods. As a subject matter expert, the Scientist provides hands-on support for assay troubleshooting and OOS/OOT investigations, including investigation planning, laboratory experiments, data interpretation, and GMP documentation. The position works cross-functionally with PDCS, Regulatory, Quality Assurance, and external QC laboratories, and provides analytical expertise for regulatory submissions and interactions. The Scientist may serve as an analytical functional lead or supporting team member for CMC programs, particularly from Phase 3 through commercialization. The role is based in an in-person working model averaging a minimum of three office days per week, with individual flexibility.

Requirements

Advanced degree (PhD or MSc) in Biochemistry, Analytical Chemistry, Molecular Biology, Pharmaceutical Sciences, or a related scientific discipline.
At least 1 year of progressive experience in biologics analytical development across clinical and/or commercial stages.
Hands-on technical and strategic experience supporting biologic modalities such as monoclonal antibodies, bispecifics, and fusion proteins.
Technical expertise in chromatography, including SEC, RP, and IEX; capillary electrophoresis, including CE-SDS and cIEF; spectroscopy, including UV/Vis, fluorescence, and CD; binding and potency bioassays; and residual and impurity testing, including HCP, DNA, and residual Protein A.
Experience with analytical method qualification and/or validation.
Experience with compendial methods, particularly USP and EP requirements.
Strong written and verbal communication skills, including the ability to develop technical reports, regulatory submission content, and presentations for technical and non-technical stakeholders.
High proficiency with Microsoft Office applications.
Experience working within quality systems and understanding of GxP-compliant documentation, ALCOA+ data integrity principles, OOS/OOT investigations, deviations, CAPA management, and audit readiness.
Ability to work effectively in a collaborative, cross-functional environment and communicate complex analytical information clearly.

Nice To Haves

Experience performing analytical method qualification or validation in accordance with ICH Q2(R2).
Knowledge of JP requirements.
Experience with JMP, Empower, and SoftMax.
Background in analytical method development and scientific understanding of Critical Quality Attributes (CQAs), Quality by Design (QbD), Design of Experiments (DOE), statistical data analysis, and relevant analytical tools.
Experience with analytical method lifecycle ownership, including method development, qualification and validation in accordance with ICH Q2, transfer to QC laboratories and/or CMOs, and continued method verification supporting commercial control strategies.
Experience overseeing analytical activities performed by CDMOs and CROs, including routine testing oversight, troubleshooting, investigations, and method qualification, validation, and transfer.
Strong cGMP experience and knowledge of regulations and expectations related to analytical testing, validation, method transfer, and analytical laboratory operations.
Knowledge of relevant regulatory guidance and expectations, including ICH Q5E, Q6B, and Q8-Q12; USP and EP requirements; FDA and EMA expectations for biologics; and GMP/GLP principles.
Experience authoring or reviewing analytical content for CTD Module 3, IND/IMPD, and BLA/MAA submissions, including responses to regulatory agency questions.
Experience developing CMC and analytical control strategies, including defining CQAs, establishing specifications, and implementing commercial control strategies aligned with QbD principles.
Familiarity with digital laboratory systems and automation, including LIMS, ELN, Chromatography Data Systems, data visualization tools, and automation or robotics within analytical workflows.
Experience applying AI-enabled tools and statistical software, such as JMP, to analytical development, data interpretation, or laboratory workflows.

Responsibilities

Lead analytical method validation, transfer, and compendial method verification across clinical development and method lifecycle stages.
Develop and implement strategies for analytical method validation, verification, transfer, and ongoing lifecycle management.
Lead cross-functional teams in assay troubleshooting and OOS/OOT investigations during method validation and transfer.
Design investigation plans and support laboratory experiments to identify root causes and develop scientifically sound solutions.
Review analytical test procedures, method performance metrics, and testing results across the global testing network.
Provide technical input into gap assessments and recommend remediation strategies, including post-validation or post-transfer method optimization when required.
Author and review analytical method transfer and validation protocols and reports for late-stage clinical and commercial programs.
Provide subject matter expertise for regulatory submissions, agency interactions, and inspections.
Serve as an analytical lead or supporting team member for CMC programs, particularly late-stage programs requiring cross-functional collaboration.
Partner with internal teams and external laboratories to ensure analytical methods are suitable, robust, compliant, and ready to support clinical and commercial manufacturing.
Collaborate with PDCS teams, Regulatory, Quality Assurance, and external QC laboratories.
Provide hands-on support for assay troubleshooting and OOS/OOT investigations, including developing investigation plans, executing laboratory experiments, interpreting data, and supporting GMP documentation.