Staff Scientitist II Biomarker Development

When you join the growing BILH team, you're not just taking a job, you’re making a difference in people’s lives.

The Staff Scientist in the Biomarker Development Immunohistochemistry (IHC) Laboratory plays a critical role in the design, development, optimization, and validation of IHC assays to support translational research, biomarker discovery, and clinical trial initiatives. This position involves working closely with cross-functional teams, including pathology, bioinformatics, clinical operations, and regulatory affairs, to ensure scientific rigor, technical accuracy, and compliance with quality standards. The Staff Scientist will lead projects focused on novel biomarker identification and characterization, contribute to strategic planning for companion diagnostics, and provide technical leadership in troubleshooting and innovation within the IHC lab.

Key responsibilities include developing and optimizing IHC protocols, performing data analysis and interpretation, maintaining detailed documentation, and contributing to scientific publications and regulatory submissions. The ideal candidate will possess a strong background in molecular biology, pathology, and immunohistochemistry, along with excellent analytical, organizational, and communication skills.

In addition to PhD- trained scientists, this position may be filled by a foreign-trained Pathologist with advanced experience in diagnostic histopathology and immunohistochemistry. Such candidates must demonstrate competency in interpreting complex tumor histopathology and IHC staining patterns (Note: U.S. Licensure is not required – this role does not involve clinical sign—out)

Job Description:

The following statements are intended to describe the general nature and level of work being performed by individuals assigned to this position. They are not intended to be an exhaustive list of all duties, responsibilities and skills required of this position.

Primary Responsibilities:

1. Plan, optimize, and validate clinical immunohistochemistry (IHC) assays to support pathology diagnostics.

2. Validate and implement FDA-approved predictive biomarker assays to inform patient treatment decisions.

3. Troubleshoot assay performance and instrumentation issues to minimize downtime, improve turnaround time, and uphold quality standards in a CAP-accredited laboratory.

4. Support the maintenance of key laboratory instrumentation – including but not limited to autostainers and tissue microarray (TMA) machines – in accordance with manufacturer specifications and regulatory requirements.

5. Establish and maintain collaborative relationships with vendors to assess new technologies and assays and negotiate cost-effective procurement.

6. Develop and maintain high-quality, sustainable on-slide controls to monitor day-to-day assay performance.

7. Mentor and guide laboratory staff on best practices in assay implementation, reagent quality control, instrumentation maintenance, and regulatory compliance.

8. Contribute to laboratory readiness for inspections and audits by drafting and updating standard operating procedures (SOPs) and related documentations, ensuring continuous compliance with CAP guidelines.

9. Partner with Board-Certified Pathologists to refine and validate biomarkers and companion diagnostic assays

Additional Responsibilities for MD-trained Pathologist candidates:

10. Interpret and evaluate immunohistochemical staining patterns in the context of complex tumor histopathology

11. Provide expert morphologic assessment of tumor samples, including recognition of rare or diagnostically challenging patterns relevant to biomarker development

12. Review assay performance from an interpretive perspective and recommend improvements to enhance diagnostic utility

Required Qualifications:

1. Doctoral degree required. Acceptable degrees include PhD or MD (For MD candidates, completion of a pathology residency or equivalent training is required. U.S. Licensure is not required)

2. 1+ years related work experience required and 0-1 years supervisory/management experience required

3. Ability to adapt work schedule in order to accommodate research, especially when monitoring sensitive experiments.

4. Advanced technical computer skills as required for technical support specific to functional area and related systems.

5. For MD Candidates: Demonstrated experience in tumor morphology and IHC interpretation is required

Preferred Qualifications:

1. Prior experience with laboratory techniques, computer analysis, creation and design of wet lab protocols and implementation of these experiments.

2. Experience in diagnostic histopathology, immunohistochemistry, or translational biomarker research

Competencies: