Analytical Development Research Scientist

Vertex is seeking a highly motivated Scientist to join the Analytical Development team. This role will lead the development of analytical cell lines that serve as critical reagents for potency assay development, functional characterization, and analytical control strategy. The Scientist will play a critical role in the development, optimization, and validation of bioassays to support characterization of biologics and other complex biologic modalities.

Operating at the interface between Research and Analytical Development, the Scientist will translate product mechanism of action into scientifically sound, phase-appropriate cell line and assay strategies. This role requires a strong background in bioassay development, biologics, and cell line development, as well as a passion for innovation and collaboration in a fast-paced, dynamic environment. The position will be based in Boston, MA.

• Lead the design, characterization and lifecycle management of stable mammalian analytical cell lines expressing targets of interest, receptor systems, or reporter constructs to support potency and functional bioassays.
• Manage CROs for the development of cell lines for use in bioassays. Act as the primary point of contact to provide technical guidance and ensure alignment with project goals and timelines. Troubleshoot and resolve technical challenges related to cell line development and maintenance.
• Translate product mechanism of action into cell line designs and cell-based assay concepts aligned with potency and analytical control strategy.

• Develop and support cell-based bioassays, including reporter gene assays, signaling pathway assays, proliferation or cytotoxicity assays, and other mechanism-based functional readouts.
• Contribute to early-stage potency assay development and ensure effective technical continuity with late-stage potency, validation, transfer, and QC implementation strategies.
• Evaluate assay and cell line performance attributes, including sensitivity, specificity, robustness, stability, reproducibility, and fitness for intended use.
• Lead or contribute to technical transfers to internal laboratories, external partners, vendors, or quality control functions, providing the technical rationale and knowledge needed for transfer.

• Independently design and execute complex experimental plans, interpret data, identify technical risks, and recommend scientifically justified solutions.
• Author and review technical reports, protocols, method documents, cell line characterization packages, technology transfer documents, and CMC source documentation supporting regulatory submissions.
• Ensure that analytical cell line generation, assay development, documentation, and data packages are aligned with applicable quality and compliance expectations, good documentation practices, and data integrity principles.

• Represent Analytical Development on cross-functional program teams and provide technical input on potency strategy, functional characterization, cell line suitability, and control strategy.
• Mentor associates through technical guidance, experimental design review, data interpretation, and development of scientific judgment.

• Identify opportunities to improve workflows, increase assay robustness and reduce development timelines.

• Proven proficiency in plate-based assays including ELISA, reporter gene assays, cytotoxicity/ADCC/CDC assays and other bioassay readout.
• Experience with technologies such as flow cytometry, qPCR or ddPCR is preferred.
• Familiarity with statistical tools and data analysis software (e.g., JMP, Graph Pad Prism, Soft Max Pro and other bioassay data analysis software).
• Knowledge of USP, FDA and ICH guidelines governing bioassay development and validation.

• Ability to multi-task as necessary, manage competing priorities and advance multiple projects within required timelines.
• Strong problem-solving and critical-thinking abilities. Attention to details.
• Excellent written and verbal communication skills with the ability to present complex data to diverse audiences.
• Demonstrated ability to work collaboratively.
• Effective delivery of objectives within the preset timeline.
• Openness to using digital, automation, and AI-enabled tools to improve data analysis,…