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. The Associate Scientist 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.

Key Responsibilities

Scientific & Technical Execution

• 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.

Routine Testing

• 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

Critical Reagents Management

• 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

Cell Culture Maintenance

• 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 assay development and continuous improvement initiatives

Innovation & Continuous Improvement

• Contribute to continuous improvement initiatives within the analytical development function, identifying opportunities to enhance assay performance, laboratory efficiency, or data quality
• Evaluate and implement new technologies, methodologies, or platforms to improve analytical capabilities and support pipeline needs
• Participate in the development and optimization of emerging bioanalytical tools and approaches to support next-generation drug development strategies

Collaboration & Leadership

• Act as a technical point of contact within own work group or project team, providing scientific guidance and fostering a culture of rigor and quality
• Serve as a functional mentor to more junior scientists and research associates, sharing technical knowledge, best practices, and professional development guidance
• Represent the Analytical Development department or function on cross-functional program or project teams and sub-teams, communicating scientific progress, risks, and recommendations effectively
• Collaborate with internal partners across Pharmaceutical Development, Bioanalysis, Quality, Regulatory Affairs, and Manufacturing to align on analytical strategies and deliverables
• Make sound scientific and operational decisions that have a meaningful impact on the work group and/or project team outcomes

Required Qualifications

• Bachelor's degree in Biochemistry, Biology, Analytical Chemistry, Immunology, or a related scientific discipline; Master's degree preferrec
• B.S. with 5+ years | M.S. with 3+ years | Ph.D. with 0–2 years of relevant industry experience in analytical development or bioanalytical sciences
• Demonstrated hands-on proficiency with ELISA (sandwich, competitive, bridging) and cell-based assay development and execution
• Proven experience in routine analytical testing, critical reagent lifecycle management, and mammalian cell culture maintenance in a regulated laboratory environment
• Experience supporting biologics or biosimilar development programs in a GMP/GLP environment preferred
• In-depth knowledge of ELISA platforms including plate-based ELISA, MSD (Meso Scale Discovery), or equivalent ligand binding assay technologies
• Proficiency in cell-based bioassay design including potency, cytotoxicity, proliferation, or receptor-binding assays
• Demonstrated experience in mammalian cell culture techniques, including cell banking, cryopreservation, and mycoplasma testing
• Expertise in critical reagent qualification, characterization, and inventory management in a GxP-compliant setting
• Working knowledge of assay validation principles per ICH, USP, and/or FDA guidance
• Familiarity with statistical analysis software (e.g., SoftMax Pro, GraphPad Prism, JMP, or equivalent)
• Experience with laboratory data management systems (LIMS, ELN) preferred
• Knowledge of biopharmaceutical drug development processes and regulatory requirements

Working Conditions

• Laboratory-based role requiring use of standard analytical instrumentation, biological safety cabinets, and cell culture facilities
• Hands-on work with biological materials, mammalian cell lines, and reagents requiring adherence to appropriate biosafety protocols
• May require occasional flexibility in scheduling to support time-sensitive studies or cross-site collaboration