Key Responsibilities:
- Independently develop and validate bioanalytical immunoassays for measuring biotherapeutics and detecting anti-drug antibodies (immunogenicity) in GLP-like or GLP environments.
- Contribute to validation and other analytical reports.
- Perform and document method qualification and validation for bioanalytical immunoassays.
- Ensure compliant documentation and support inspection readiness.
- Interpret results, plan next steps, compile final data summaries, and present results to stakeholders.
- May lead projects and provide oversight of experimental design and data review for junior staff.
- May lead scientific collaborations and/or contracted research as needed.
- Serve as a technical point of contact within the group.
- Troubleshoot assay problems and instrument malfunctions.
- Maintain required training per standard operating procedures; maintain notebooks and other documentation per departmental guidelines.
- Achieve objectives consistent with BMS Behaviors.
- May lead or contribute to poster, publication, and oral presentation of findings (internal and external).
Qualifications & Experience:
- Bachelorโs degree with 6+ years related industry experience; or Masterโs degree with 5+ years; or Ph.D. with 2+ years.
- Experience developing and validating bioanalytical PK/TK and anti-drug antibody immunoassays.
- Knowledge of GLP, 21 CFR Part 11, and FDA Bioanalytical Guidance.
- Some LIMS experience (e.g., Watson) for quantitation, data handling, and archival.
- Knowledge of drug discovery and development process.
- Good verbal and written communication; able to independently interpret and deliver results.
- Ability to work effectively with internal and external stakeholders.
- Excellent problem-solving skills.
Compensation (included in posting): Princeton, NJ - US $123,670 - $149,855.
Application instructions: None provided in the extracted posting text.