Associate Scientist, Analytical Development

About the role

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.

Responsibilities

• 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.
• Evaluate and qualify new cell lines or cell-based platforms to support assay development and continuous improvement initiatives.
• 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.

Qualifications

• Bachelor's degree in Biochemistry, Biology, Analytical Chemistry, Immunology, or a related scientific discipline; Master's degree preferred
• 3+ 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
• Expertise in cell-based bioassay design including potency, cytotoxicity, proliferation, or receptor-binding assays
• 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

Skills

• Hands-on proficiency with ELISA 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
• In-depth knowledge of ELISA platforms including plate-based ELISA, MSD (Meso Scale Discovery), or equivalent ligand binding assay technologies
• Expertise in cell-based bioassay design including potency, cytotoxicity, proliferation, or receptor-binding assays
• 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

Benefits

Health Coverage: Medical, pharmacy, dental, and vision care.

Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).

Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.

Work-life Benefits Include Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees))Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays

All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.