Associate Scientist, Analytical Development

Position Summary

The Associate Scientist, Analytical Development is a key scientific contributor responsible for the design and execution of bioanalytical assays. This role requires hands‑on expertise in molecular techniques, ELISA and cell‑based assay methodologies, combined with a strong foundation in analytical science. Operates under limited supervision, exercises scientific judgment in experimental planning, and plays an active role in driving project team success through technical excellence and cross‑functional collaboration.

• Design and execute the next logical steps in a series of related experiments and studies, applying scientific reasoning to advance analytical development objectives
• Develop, optimize, qualify, and validate ELISA and cell‑based assays (e.g., potency assays, binding assays, reporter gene assays) in support of Process Development and CMC
• Generate, analyze, and interpret complex analytical data sets; prepare clear and accurate scientific documentation including assay reports, protocols, SOPs, and technical summaries
• Troubleshoot routine and non‑routine assay problems, applying systematic problem‑solving approaches to identify root causes and implement corrective actions
• Ensure all laboratory work is conducted in compliance with GxP regulations, internal SOPs, and applicable regulatory guidelines

• Perform routine analytical testing in support of drug substance and drug product characterization, stability studies, comparability studies, and release testing activities
• Execute qualified and validated ELISA and cell‑based assays in accordance with approved protocols and SOPs, ensuring data accuracy, reproducibility, and traceability
• Document all testing activities thoroughly in electronic laboratory notebooks (ELN) or LIMS, maintaining complete and audit‑ready records in compliance with GxP standards
• Review and verify analytical data for accuracy and completeness, escalating deviations or out‑of‑specification results through appropriate channels in a timely manner
• Support method transfers, cross‑site validations, and tech transfer activities as needed to ensure continuity of analytical testing operations

• Oversee the lifecycle management of critical reagents used in ELISA and cell‑based assays, including procurement, qualification, characterization, storage, and inventory tracking
• Conduct bridging and comparability studies for critical reagent lots to ensure consistency in assay performance across transitions and reagent changes
• Maintain detailed reagent records including certificates of analysis, qualification data, expiration tracking, and chain‑of‑custody documentation in compliance with internal SOPs
• Collaborate with internal stakeholders and external vendors to source, evaluate, and qualify new critical reagents, including reference standards, antibodies, and biological materials
• Proactively monitor reagent inventory levels and lead mitigation strategies to prevent supply gaps that could impact testing timelines or project deliverables
• Identify risks associated with critical reagent availability or performance and propose contingency plans to minimize impact on analytical programs

• Maintain and manage cell lines used in cell‑based bioassays, including routine passaging, cryopreservation, thawing, and mycoplasma testing in accordance with established SOPs
• Monitor cell health, growth kinetics, morphology, and passage number, maintaining detailed cell culture logs and ensuring cells are within validated passage ranges for assay use
• Establish and maintain working and master cell banks, ensuring proper storage, documentation, and qualification of banked cell stocks
• Perform routine cell‑based assay quality controls to confirm cellular performance metrics are within acceptable parameters prior to use in analytical testing
• Troubleshoot cell culture‑related issues, including contamination events, performance drift, and growth anomalies, implementing corrective actions and preventive measures as appropriate
• Evaluate and qualify new cell lines or cell‑based platforms to support…