Scientist I, Analytical Development and Clinical QC

You will lead strategies for the validation, verification, and transfer of analytical and compendial methods supporting clinical and commercial biologics. You will also help define the overall analytical testing strategy throughout the product lifecycle, applying your technical expertise to solve complex analytical challenges and ensure robust, phase-appropriate methods.

As a subject matter expert, you will provide hands-on support for assay troubleshooting and OOS/OOT investigations, including developing investigation plans, executing laboratory experiments, interpreting data, and supporting associated GMP documentation.

Working cross-functionally, you will collaborate closely with PDCS teams, Regulatory, Quality Assurance, and external QC laboratories. You will provide analytical expertise for regulatory submissions and interactions related to method validation, verification, and transfer activities.

You may also serve as an analytical functional lead or supporting team member for CMC programs, with a particular focus on Phase 3 through commercialization and the associated end-to-end analytical activities.

You Will Be Responsible For

• Leading all aspects of analytical method validation, transfer, and compendial method verification across clinical development and method lifecycle stages.
• Developing and implementing strategies for analytical method validation, verification, transfer, and ongoing lifecycle management.
• Leading cross-functional teams in assay troubleshooting and OOS/OOT investigations during method validation and transfer activities.
• Designing investigation plans and supporting the execution of laboratory experiments to identify root causes and develop scientifically sound solutions.
• Reviewing analytical test procedures, method performance metrics, and testing results across the global testing network.
• Providing technical input into gap assessments and recommending remediation strategies, including post-validation or post-transfer method optimization when required.
• Authoring and reviewing analytical method transfer and validation protocols and reports for late-stage clinical and commercial programs.
• Providing subject matter expertise for regulatory submissions, agency interactions, and inspections.
• Serving as an analytical lead or supporting team member for CMC programs, particularly late-stage programs requiring rigorous cross-functional collaboration.
• Partnering with internal teams and external laboratories to ensure analytical methods are suitable, robust, compliant, and ready to support clinical and commercial manufacturing.

You Will Need To Have

• An advanced degree, PhD or MSc, in Biochemistry, Analytical Chemistry, Molecular Biology, Pharmaceutical Sciences, or a related scientific discipline.
• 1+ years of progressive experience in biologics analytical development across clinical and/or commercial stages.
• Demonstrated hands-on technical and strategic experience supporting biologic modalities such as monoclonal antibodies, bispecifics, and fusion proteins.
• Technical expertise across relevant analytical technologies, including chromatography (SEC, RP, IEX), capillary electrophoresis (CE-SDS, cIEF), spectroscopy (UV/Vis, fluorescence, CD), bioassays (binding and potency), and residual and impurity testing (HCP, DNA, residual Protein A).
• Experience with analytical method qualification and/or validation. Experience performing these activities in accordance with ICH Q2(R2) is a plus.
• Experience with compendial methods, particularly USP and EP requirements. Knowledge of JP requirements is preferred.
• Strong written and verbal communication skills, with the ability to develop clear technical reports, regulatory submission content, and presentations for both technical and non-technical stakeholders.
• High proficiency with Microsoft Office applications. Experience with JMP, Empower, and SoftMax is preferred.
• Experience working within quality systems and an understanding of GxP-compliant documentation, ALCOA+ data integrity principles, OOS/OOT investigations, deviations, CAPA management, and audit readiness.
• Ability to work effectively in a highly collaborative, cross-functional environment and communicate complex analytical information clearly.

We Would Prefer For You To Have

• A strong background in analytical method development, with scientific understanding of Critical Quality Attributes (CQAs), Quality by Design (QbD), Design of Experiments (DOE), statistical data analysis, and relevant analytical tools.
• Demonstrated 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.
• Strong 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.