Senior Scientist, Assay Development (IVD)

Sarmal; San Diego (CA); Hybrid; USD 125,000 - 160,000; Full time

Benefits offered by this job

Medical, dental, and vision coverage

Company-paid life insurance

401(k) retirement plan

Generous paid time off

Employee perks and discount programs

Job summary

Sarmal, Inc. is a San Diego-based biotechnology company pioneering next-generation genomics and molecular detection platforms.

The Staff Scientist, Assay Development will advance molecular diagnostic assays for FDA-regulated IVD products and work with the team to optimize chemistry, formulations, and analytical performance. The role emphasizes reagent development, stability studies, lyophilization, validation, and preparation for FDA 510(k) submissions, with collaboration across Quality,

Qualifications

• Expertise in reagent development and formulation for molecular diagnostic or IVD products.
• Hands-on experience optimizing assay chemistry and improving analytical performance of molecular diagnostic assays.
• Experience designing and executing reagent stability studies, accelerated aging, shelf-life determination, and lyophilized reagent development.
• Experience supporting analytical verification and validation of FDA-regulated IVD products.
• Working knowledge of FDA Design Controls, ISO 13485, CLSI guidelines, and FDA 510(k) requirements.
• Strong experimental design, statistical analysis, troubleshooting, and scientific problem-solving skills.
• Excellent technical writing, documentation, communication, and cross-functional collaboration skills.
• Ability to manage multiple priorities in a fast-paced product development environment.

Responsibilities

• Collaborate with assay development scientists to optimize molecular diagnostic assays through reagent formulation, assay chemistry optimization, and analytical performance improvements.
• Design, develop, and optimize reagent formulations, including enzymes, primers, probes, buffers, stabilizers, and other assay components to support robust assay performance.
• Design and execute reagent characterization, stability, accelerated aging, shelf-life, and lyophilization studies to support commercial IVD product development.
• Design and execute experiments to evaluate and improve assay analytical performance, including sensitivity, specificity, precision, robustness, reproducibility, and limit of detection.
• Support analytical verification and validation activities and generate technical data to support FDA-regulated IVD product development and FDA 510(k) submissions.
• Collaborate with Quality, Regulatory Affairs, Engineering, and Manufacturing to support Design Controls, technology transfer, manufacturing readiness, and commercialization.
• Analyze experimental data, troubleshoot reagent and assay performance issues, and communicate technical findings through reports and presentations.
• Maintain accurate experimental documentation in accordance with quality system requirements.

Skills

reagent development

assay optimization

analytical performance

FDA/regulatory experience

Design Controls ISO 13485

statistical analysis

technical writing

cross-functional collaboration

prioritization in fast-paced

Education

Ph.D. in Molecular Biology or related

M.S. in related field with 8+ years experience

2+ years in FDA-regulated MD/IVD products

Tools

PCR/qPCR

Job description

Sarmal, Inc. is a San Diego-based biotechnology company pioneering next-generation genomics and molecular detection platforms.

The Staff Scientist, Assay Development will advance molecular diagnostic assays for FDA-regulated IVD products and work with the team to optimize chemistry, formulations, and analytical performance. The role emphasizes reagent development, stability studies, lyophilization, validation, and preparation for FDA 510(k) submissions, with collaboration across Quality,