Technologist - Assay Development

Fulgent Genetics; Alpharetta (GA); On-site; USD 85,000 - 120,000; Full time

Job summary

CSI Laboratories, a Fulgent Genetics Company, is seeking an Assay Development Technologist to drive assay development from concept to product proof-of-concept. You will design, validate, and implement automated, high-throughput genetic tests in collaboration with the Molecular Director and senior management.

You will initiate study projects, interpret results, and drive new tests from concept to launch, collaborating with the molecular department and management, troubleshooting and maintaining

Qualifications

• Masters or Bachelor's degree with extensive experience in assay development.
• Experience with human genetics and molecular biology techniques.
• Prior experience with laboratory regulations (CLIA, CAP, NYS).
• Ability to multi-task, work independently, and prioritize tasks.
• MB or equivalent certification preferred.

Responsibilities

• Demonstrate high attention to detail with molecular biology principles and instrumentation.
• Lead research and development by designing or optimizing molecular assays.
• Author validation plans, SOPs and other documents for assay development.
• Identify bottlenecks and streamline testing procedures.
• Play a key role in developing new tests and troubleshooting existing assays.
• Serve as SME and train team members; perform routine assays and maintain proficiency.

Skills

Assay development

Molecular biology

Laboratory regulations

Multi-tasking

Independent work

Education

Bachelor's or Master's degree

Tools

Laboratory instrumentation

Job description

About Us

CSI Laboratories, a Fulgent Genetics Company, is a nationally recognised cancer testing and diagnostics laboratory experienced in helping pathologists and oncologists diagnose and treat cancer patients.

Founded in 2011, our parent entity, Fulgent Genetics, has evolved into a premier full-service genomic testing company built around a foundational technology platform.

Through our diverse testing menu, Fulgent is focused on transforming patient care in oncology, anatomic pathology, infectious and rare diseases, and reproductive health. We believe that by providing a wide range of effective, flexible testing options in conjunction with best-in-class service and support, we can redefine the way medicine is managed for patients and clinicians alike.

Since integrating with our therapeutic development business, Fulgent is also developing drug candidates for treating a broad range of cancers using a novel nanoencapsulation and targeted therapy platform. By merging our fields of expertise, we aim to become a fully integrated precision medicine company.

Summary of Position

The Assay Development Technologist is a cross-functional role comprised of assay development in collaboration with the Molecular Director, Senior Management, and the Molecular Department to drive decision-making and data-driven product development.

The Assay Development Technologist will initiate study projects, investigate the feasibility of potential projects, design and develop methods and assays, generate and interpret study results through the application of scientific principles and analytical techniques, and drive novel molecular biology assays from research to product proof-of-concept.

The Assay Development Technologist will be responsible for designing and developing fully automated, high-throughput genetic tests from concept through commercial launch. The assay development technologist strives to create a highly collaborative environment, with an emphasis on cross-functional projects. Continually assessing and integrating cutting-edge technology into our laboratory and development process, as well as will playing a key role in developing new tests as well as troubleshooting and maintaining existing assays in collaboration with the molecular department.

Key Job Elements

• Demonstrate high attention to detail with a depth of knowledge in the principles of molecular biology and the use of instrumentation for genetic testing.
• Work with Molecular Director and Senior Management to identify new assays with the potential to bring them in house
• Lead research and development by designing new or optimizing existing molecular assays
• Utilize molecular biology techniques and instrumentation for the successful validation and implementation of assays into established workflows.
• Author all documents needed for assay development and implementation (i.e. validation plan, SOP, etc.)
• Identify bottlenecks and potential solutions for streamlining testing procedures
• Play a key role in developing new tests as well as troubleshooting and maintaining existing assays
• Serves as SME and trains team members
• Performs routine assays and maintains proficiency in those assays

Qualifications

Knowledge/Experience

• Masters or Bachelor's Degree with extensive experience with assay development.
• Experience with human genetics and molecular biology techniques.
• Prior experience with laboratory regulations (CLIA, CAP, NYS) highly preferred.
• Ability to multi-task, work independently, and prioritize tasks.
• MB or equivalent certification preferred.

Supervisory Responsibilities

• No

Reports To

• Molecular Manager

Environment

Fulgent Therapeutics LLC/CSI is an Equal Employment Opportunity Employer. The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions. The term "qualified individual with a disability" means an individual with a disability who, with or without reasonable accommodation, can perform the essential functions of the position.

• A moderate amount of standing is often required.
• Potential Exposure to toxic chemicals and the biohazards associated with handling blood, solid tissue, and body fluids.
• Possess manual dexterity to perform analytical testing.