SUMMARY
We are seeking an experienced and innovative Senior Scientist to lead the development of next‑generation molecular diagnostic assays for prenatal applications, including cell‑free DNA (cfDNA)–based testing, targeted sequencing for single‑gene disorders, and other emerging prenatal biomarkers.This role is ideal for a highly skilled scientist who brings deep technical expertise, scientific leadership, and the ability to influence strategy across complex R&D programs. The Senior Scientist will drive assay development from concept through validation and transfer, while shaping the technological direction of the prenatal diagnostics portfolio.
Key Responsibilities
- Provide scientific leadership in the design, development, and optimization of sequencing-based prenatal diagnostic assays, including cfDNA, targeted NGS, and RNA-based workflows.
- Lead high-complexity assay development projects, including setting technical strategy, timelines, and risk mitigation plans.
- Serve as a subject matter expert in NGS workflows and prenatal genomics, providing guidance across programs.
- Design, execute, and interpret advanced experiments to evaluate analytical performance, robustness, and biological variability across prenatal sample types.
- Define assay performance criteria and collaborate with validation teams to design verification and validation studies for clinical readiness.
- Lead transfer of assays to operations, supporting workflow scale-up, automation, and process robustness.
- Collaborate with bioinformatics, automation, clinical, regulatory, and quality teams to ensure seamless end‑to‑end assay development.
- Identify and assess new technologies, chemistries, and workflow innovations relevant to prenatal assay advancement.
- Mentor junior scientists and project teams, providing scientific and technical guidance.
- Author and review technical documentation, study reports, protocols, and materials supporting regulatory and clinical use.
- Present scientific findings and program updates to stakeholders and leadership.
- Ensure compliance with quality systems, regulatory requirements, and company policies.
Required Qualifications
- Ph.D. in molecular biology, biochemistry, genetics, genomics, or a related field.
- Typically 5+ years of industry experience in molecular assay development, ideally within clinical or regulated diagnostics.
- Demonstrated expertise in NGS‑based assay development, including library preparation, PCR/qPCR, and nucleic acid extraction.
- Proven experience working with diverse sample types, including blood, saliva, buccal samples, tissue, and cfDNA.
- Deep understanding of the assay development life cycle, from feasibility through optimization, V&V, and technical transfer.
- Strong ability to analyze and interpret complex experimental and sequencing datasets.
- Excellent problem‑solving skills with the ability to troubleshoot complex technical challenges.
- Strong written and verbal communication skills, with the ability to clearly convey scientific concepts to diverse audiences.
Preferred Qualifications
- Experience working in regulated environments such as CLIA, CAP, ISO, or FDA settings.
- Track record of leading multi‑disciplinary assay development programs.
- Experience with automation and high-throughput liquid handling platforms.
- Familiarity with bioinformatics pipelines and NGS data quality metrics.
- Experience supporting regulatory submissions or clinical assay launches.
- Demonstrated ability to mentor and influence technical direction of scientific staff.
PHYSICAL DEMANDS AND WORK ENVIRONMENT
- Frequently required to sit or stand for extended periods.
- Frequently required to use hand and finger dexterity to operate laboratory equipment.
- Frequently required to communicate verbally and visually interpret technical data.
- Occasionally exposed to bloodborne or airborne pathogens or infectious materials.
- Work is primarily performed in a laboratory and office environment.
EEO Statement:
Baylor Genetics is proud to be an equal opportunity employer dedicated to building an inclusive and diverse workforce. We do not discriminate based on race, religion, color, national origin, sex, sexual orientation, age, gender identity, veteran status, disability, genetic information, pregnancy, childbirth, or related medical conditions, or any other status protected under applicable federal, state, or local law.
Note to Recruiters:
We value building direct relationships with our candidates and prefer to manage our hiring process internally. While we occasionally partner with select recruitment agencies for specialized roles, we do not accept unsolicited resumes from recruiters or agencies without a written agreement executed by the authorized signatory for Baylor Genetics ("Agreement"). Any resumes submitted to Baylor Genetics in the absence of an Agreement executed by Baylor Genetics' authorized signatory, will be considered the property of Baylor Genetics, and Baylor Genetics will not be obligated to pay any associated recruitment fees.
