Clinical Analytical Development Associate Scientist (6-Month Contract)

VitalBio; Temple (TX); On-site; USD 80,000 - 110,000; Full time

Job summary

VitalBio in Texas is seeking a Clinical and Analytical Development Associate to help develop and verify cell-based assays for a new clinical diagnostic analyzer. You will work on a CBC panel with 5-part differential on an automated platform, collaborating with scientists, engineers, and software teams.

The role emphasizes adhering to FDA/CLIA guidelines, maintaining detailed records, troubleshooting, and applying new technologies to improve assay development and integration.

Qualifications

• 2+ years of hands-on experience in clinical chemistry assay development or cell-based assays.
• Experience with PCR/qPCR, ELISA, flow cytometry.
• Experience with regulatory standards (FDA/CLIA) is advantageous.
• Ability to script in Python or R to automate workflows.

Responsibilities

• Support optimization and verification of a CBC panel on automated platform.
• Troubleshoot reagents, consumables, and instrumentation.
• Maintain protocols and results under regulatory standards.
• Collaborate with interdisciplinary teams to integrate assays into workflows.
• Identify and resolve technical challenges to ensure assay performance.
• Maintain quality control measures for assay consistency.
• Stay updated on emerging technologies to enhance development processes.

Skills

PCR

qPCR

ELISA

Flow cytometry

Python scripting

R scripting

Data analysis

MS Word

MS Excel

Regulatory knowledge

Education

Bachelor’s or Master’s degree in Molecular Biology/Biochemistry/Biotechnology/Bioengineering or related field

Tools

Microfluidics

Next-generation sequencing

Automated microscopy systems

Bioanalytical instrumentation

Job description

Position Summary:
We are seeking a skilled and motivated Clinical and Analytical Development Associate to play a pivotal role in developing and verifying cell-based assays for a new clinical diagnostic analyzer. This position offers an exciting opportunity to contribute to groundbreaking advancements in biotechnology while working in a collaborative and fast-paced environment.

Key Responsibilities:

• Assay Development: Support optimization and verification efforts for a complete blood count panel with 5-part differential on an automated analytical platform.

• Integration: Troubleshoot reagents, consumables and complex instrumentation to ensure robust performance and reliability.

• Documentation: Maintain detailed records of experimental protocols, results, and conclusions in compliance with regulatory standards (e.g., FDA, CLIA).

• Collaboration: Work closely with interdisciplinary teams including scientists, engineers, and software to integrate assays into comprehensive diagnostic workflows.

• Troubleshooting: Identify and resolve technical challenges related to assay performance and integration, ensuring continuous improvement.

• Quality Control: Implement and maintain rigorous quality control measures to uphold assay consistency and reliability.

• Innovation: Stay updated with emerging technologies and contribute innovative ideas to enhance assay development processes and integration strategies.

Qualifications:

• Bachelor’s or Master’s degree in Molecular Biology, Biochemistry, Biotechnology, Bioengineering or a related field.

• 2+ years of hands‑on experience in clinical chemistry assay development, immunoassays, and/or cell-based assays within a biotech or diagnostic industry setting is preferred

• Proficiency in molecular biology techniques such as PCR, qPCR, ELISA, flow cytometry, and other relevant assays.

• Prior experience in handling biological specimens is preferred.

• Experience with microfluidics, next generation sequencing instrumentation, and/or automated microscopy systems is highly desirable.

• Ability to follow good lab practices and pipetting techniques with a high level of manual dexterity.

• Ability to follow instructions, protocols and SOPs to conduct experiments using bioanalytical instrumentation.

• Ability to do scripting in python or other programming languages like R to automate workflows and processes

• Familiarity with MS Word and MS Excel for data analysis and documentation.

• Strong analytical skills with the ability to troubleshoot technical issues independently.

• Excellent organizational skills, attention to detail and effective communication skills with the ability to collaborate in a team‑oriented environment.

• Experience with regulatory requirements (e.g., FDA, CLIA) and quality management systems is advantageous.

About Vital Bio

Vital is revolutionizing point-of-care diagnostics with our VitalOne platform, delivering real‑time care wherever patients are. Our mission is to democratize health technology, making healthcare more accessible and proactive.

Our global team of experts spans chemistry, software, engineering, and microfluidics. We thrive on change, operate on trust, and value diverse perspectives. Our growth‑minded culture empowers front‑line decision‑making and fosters impactful work.

We seek tenacious, bold individuals ready to transform healthcare. At Vital, your talent will make a difference as we work to ensure everyone has access to care when and where they need it.

Vital Biosciences Inc. is an equal opportunity employer and values diversity in the workplace. We are therefore happy to accommodate any individual needs in keeping with the Ontario Human Rights Code and the Accessibility for Ontarians with Disabilities Act. If you require accommodation in order to participate in our hiring process, please contact us to make your needs known in advance

As part of our recruitment process, we may use automated or AI-supported tools to assist with application review and screening. These tools are used to support, not replace, human decision-making. Final hiring decisions are always made by our hiring team.