Molecular Assay Development Specialist

Job Specific Duties and Responsibilities:

• Work closely with the Technical Director and Laboratory Manager to facilitate the design and development of new molecular assays, including validation plans and associated timelines.

• Execute validation of new molecular assays by performing experiments, completing data analysis, and effectively communicating progress and results to Technical Director and Laboratory Manager

• Delegate additional validation tasks to other technical staff as needed.

• Participate in regular data reviews with the Technical Director and Laboratory Manager.

• Obtain necessary reagents and samples promptly for assay validations.

• Maintain validation supply inventory by monitoring inventory level; anticipating needed supplies; placing and expediting orders for supplies; verifying receipt of supplies.

• Lead the development of appropriate quality metrics for each new assay to deliver optimum assay performance.

• Train and support laboratory staff on new assays as they are brought online following validation.

• Serve as a subject matter expert on laboratory procedures and a contact person for troubleshooting of assays and instrumentation.  

• Assist with problem resolution to technical and personnel issues that surface in daily laboratory operations.

• Formulate process improvements to optimize and streamline workflows, including assay automation.

• Maintains the laboratory in a constant state of compliance with all applicable accreditation standards.

• Assumes all other job responsibilities of a Laboratory Scientist as needed.

• Maintains safe and clean working environment that protects patients and employees by adhering to infection-control, hazardous waste and other safety policies and protocols.

• Maintains professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; participating in professional societies.

• Performs other related duties as required and directed.

Qualifications:

Required:

•   Bachelor’s degree in Medical Technology or related fields.

   Preferred:

• MT/MLS (ASCP) or equivalent

• Completion of internship program from an approved school of Medical Technology or school of Clinical Laboratory Science.

Knowledge, Skills, and Abilities:

• Excellent laboratory skills

• Excellent analytical mindset and troubleshooting skills

• Strict attention to detail and quality procedures

• Strong organizational and communication skills

• Commitment to both our clients and their patients to provide the most accurate test results possible, in a timely fashion

• A strong understanding of HIPPA regulations

*This document is intended to describe the general nature and level of work performed and the requirements of the position. It is not intended to serve as an exhaustive list of all duties, skills, and responsibilities of personnel so classified; nor is it intended to limit the right of any leader to assign or direct employees under his/her direction.

Who We Are: 

Helix is a value-based, state-of-the-art clinical laboratory on a mission to elevate the lab space through compliance, high ethics, innovation and a best in class client experience. Helix incorporates the latest technology and methods to provide comprehensive diagnostics including toxicology testing, pathogen detection, blood testing and Pharmacogenomics (PGx) testing.

Expected Use and Disclosure of Protected Health Information: 

Employees in this position are expected to have access to protected health information and other confidential business information from throughout the organization as is needed to fulfill their responsibilities in evaluating and reducing risk to the organization. No protected health information will be disclosed outside the organization unless specifically required by state or federal law. *This document is intended to describe the general nature and level of work performed and the requirements of the position. It is not intended to serve as an exhaustive list of all duties, skills and responsibilities of personnel so classified; nor is it intended to limit the right of any leader to assign or direct employees under his/her direction.