Junior Scientist I, Technical Operations

2 weeks ago

San Diego, California, United States PROMETHEUS LABORATORIES INC Full time
Position Overview

SUMMARY
The role involves supporting the creation, validation, and transfer of diagnostic tests within the Clinical Laboratory framework. Previous experience in In Vitro Diagnostics (IVD) manufacturing is advantageous.

KEY RESPONSIBILITIES include, but are not limited to:

  • Collaborating as a team member in the innovation and rollout of new diagnostic tests, along with providing technical assistance for current tests.
  • Following directives from management and senior personnel to achieve project objectives and deadlines.
  • Partnering with senior staff to design and execute development, optimization, investigation, and assessment studies for new technologies.
  • Assisting senior staff in the design and development processes, including specification establishment, validation, verification, process transfer, manufacturing, quality control testing, and post-launch monitoring.
  • Contributing to the authorship and revision of Standard Operating Procedures (SOPs), forms, policies, batch records, proposals, reports, investigations, and laboratory notebook entries.
  • Engaging in data analysis with senior staff utilizing advanced algorithms and statistical methods to derive conclusions and recommendations.
  • Supporting databases related to quality control for diagnostic tests, clinical samples, and analytical studies.
  • Creating and maintaining clinical data as required.
  • Preparing summary reports and delivering presentations to senior staff and project teams.
  • Adhering to CAP/CLIA regulations, safety protocols, and other relevant guidelines.

SUPERVISORY ROLE

This position does not entail supervisory responsibilities.

QUALIFICATIONS

To excel in this role, candidates must demonstrate the ability to fulfill each essential duty effectively. The following qualifications are indicative of the knowledge, skills, and abilities required:

EDUCATION and EXPERIENCE

A BA/BS degree in biological or life sciences with 5-8 years of product development and/or laboratory experience, or a MS in biological or life sciences with 2-5 years of relevant experience is typically required. Hands-on experience in reagent preparation and conducting immunoassays or nucleic acid assays such as ELISA, HPLC, and SNP assays is essential. Familiarity with diagnostics, automation, and validation of analytical methods is preferred. Experience in GLP/GMP/FDA and/or CLIA/CAP regulated environments is also preferred.

LANGUAGE PROFICIENCY

Ability to read and interpret professional journals, technical procedures, and governmental regulations is essential. Candidates should be capable of writing reports, business correspondence, procedure manuals, and SOPs, as well as effectively presenting information and addressing inquiries.

MATHEMATICAL ABILITY

Competence in applying mathematical concepts and operations to evaluate the reliability and validity of data is required. Proficiency in Excel is mandatory.

REASONING SKILLS

Ability to identify problems, gather data, establish facts, and draw valid conclusions is necessary. Candidates should be able to interpret various technical instructions in mathematical, written, or diagrammatic forms.

CERTIFICATIONS

No specific certifications are required.

PHYSICAL REQUIREMENTS

The physical demands outlined here are representative of those that must be met by an employee to successfully perform the essential functions of this role. Reasonable accommodations may be made for individuals with disabilities.

While executing the responsibilities of this position, the employee is regularly required to sit, stand, and communicate. The employee frequently uses hands for handling and manipulating objects. Occasionally, the employee may need to stand, walk, and reach with hands and arms. The employee must be able to lift and/or move up to 55 pounds. Specific vision abilities required include close vision, distance vision, peripheral vision, depth perception, and the ability to adjust focus.

WORK ENVIRONMENT

The characteristics of the work environment described here are representative of those an employee may encounter while performing the essential functions of this role. Reasonable accommodations may be made for individuals with disabilities. While performing the duties of this job, the employee may be exposed to moving mechanical parts, fumes or airborne particles, potentially infectious bodily fluids, toxic or caustic chemicals, and extreme cold. The noise level in the work environment is moderate.

All qualified applicants are considered for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, veteran status, or other protected class.

The statements herein are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified.

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