Position SummaryThe 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 ResponsibilitiesScientific & 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
Compensation Overview:Cambridge - MA - US: $96,010 - $116,339
The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.
Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:
- 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
Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.
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.
*Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.
