Join our Late Stage Analytical team and play a key role in advancing biologics through late-stage clinical development and commercialization. In this role, you will bring deep analytical expertise and help shape analytical strategies across the CMC lifecycle, with a particular focus on method validation, verification, transfer, and lifecycle management.
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, such as SEC, RP, and IEX.
Capillary electrophoresis, including CE-SDS and cIEF.
Spectroscopy, such as UV/Vis, fluorescence, and CD.
Bioassays, including binding and potency assays.
Residual and impurity testing, including HCP, DNA, and 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…