Description
**Shift will be Wednesday - Sunday 6:00am - 2:30pm
Job Summary:
The CLS works under minimal supervision, and is responsible for complex molecular diagnostic testing laboratory procedures using all types of qualified specimens submitted for testing. Please note this is a Tuesday through Saturday schedule.
Essential Duties and Responsibilities:
Laboratory Activities:
- Exceptional knowledgeable of all techniques involving DNA/RNA extractions, PCR and RT-PCR reactions, DNA sequencing and other molecular genetic techniques
- Considered by the CLS I staff as a resource for micro array technology, such as, labeling RNA, hybridizing, washing and scanning micro arrays
- Perform diagnostic laboratory activities on the basis of standard operating procedures
- Compose and revise Standard Operating Procedures (SOP’s) under the direction of the Lab Director, Lab Ops Director or Lab Manager.
- Consults with the Lab Director, Lab Ops Director or Lab Manager regarding the daily work flow of the clinical laboratory and troubleshooting
- Performs all aspects of laboratory procedures following safety guidelines and adhering to protocols as it pertains to Agendia, Inc.’s health and safety policies and procedures
- Responsible for assigned projects (instrument comparisons, instrument calibrations, staff schedules, process improvement, lab training and competency, assay or instrument validation, etc.)
- Performs other related duties as required or assigned in the laboratory
Post Analytic:
- Maintain a filling system (paper or electronic) for completed patient data
- Register results and data in lab journal and LIMS
- Assist other personnel and departments when requested
Professional:
- Initiate own career development by being familiar with current literature, seeking out seminars, workshops and other professional meetings relating to professional field.
- Adhere to various federal and state laws, regulations and guidelines (e.g. California labor laws, OSHA, CLIA, College of American Pathologist, New York State Department of Health, GLP, GCP, HIPAA, ISO 13485, and other as applicable).
- Exhibit ethical and professional behavior at all times.
- Maintain patient confidentiality at all times.
The above listing represents the general duties considered essential functions of the job and is not to be considered a detailed description of all the work requirements that may be inherent in the position.
Requirements
Contacts:
This position may interact with all departments within the company as well as outside vendors and regulatory agencies.
Education and Experience Requirements:
- At least a Bachelor’s degree required
- 4+ years clinical laboratory experience with a Bachelor’s degree and 3+ years clinical lab experience with a Master’s degree, or 2+ years clinical lab experience with a doctoral degree.
- Must have experience with molecular diagnostic techniques, histology techniques, working with databases, microarray analysis, working with quality systems and lab automation and statistical analysis and/or software.
Certificates and License Requirements:
- California Clinical Laboratory Scientist (CLS) or Clinical Genetic Molecular Biologist Scientist (CGMBS) License or any other specialist license that can perform high complexity molecular testing.
Skills and Qualifications Requirements:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to individuals with disabilities to perform the essential functions.
- Must have an exceptional understanding of general laboratory techniques and medical terminology with emphasis for the department specific techniques.
- Ability to demonstrate a high level of initiative, balanced assertiveness and team orientation.
- Ability to demonstrate excellent time management skills.
- Ability to handle biological samples and potentially hazardous chemicals.
- Ability to operate equipment with proficiently to successfully execute test procedures.
- Computer skills and laboratory automation knowledge.
- Exceptional ability to communicate effectively and follow written and verbal instructions.
- A CLS II must be on-site during testing procedures.
Supervisory Responsibilities:
- This position requires no formal supervisory responsibilities.
Environment/Safety/Work Environment:
- General office environment. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Maintains a clean, neat, and orderly work area.
- Adheres to Department Specific Safety Guidelines.
- In the absence of the Laboratory Director, Lab Ops Director or Lab Manager, a CLS II must be on-site during testing procedures.
Physical Demands:
- Standing, sitting, walking, bending, reaching, manual manipulation, and lifting up to 15 pounds.
- All candidates must take a color vision test.
Skills Required
- Bachelor's degree
- Clinical laboratory experience (4+ years with Bachelor's; 3+ years with Master's; 2+ years with doctoral degree)
- Experience with molecular diagnostic techniques (DNA/RNA extraction, PCR, RT-PCR)
- Experience with DNA sequencing
- Microarray technology and microarray analysis
- Histology techniques
- Experience working with databases and LIMS
- Experience with quality systems and lab automation
- Statistical analysis and/or statistical software
- California Clinical Laboratory Scientist (CLS) or Clinical Genetic Molecular Biologist Scientist (CGMBS) license or equivalent specialist license
- Ability to handle biological samples and potentially hazardous chemicals
- Computer skills and ability to operate laboratory equipment and automation
- Must pass a color vision test
What We Do
Agendia is a precision oncology company headquartered in Irvine, California, committed to bringing patients with early stage breast cancer and their physicians the information they need to make the best decisions for the full treatment journey. The company currently offers two commercially-available genomic profiling tests, supported by the highest levels of clinical and real world evidence, that provide comprehensive genomic information that can be used to identify the most effective breast cancer treatment possible for each patient. MammaPrint®, the 70-gene breast cancer recurrence assay, is the only FDA-cleared risk of recurrence test backed by peer-reviewed, prospective outcome data and inclusion in both national and international treatment guidelines. BluePrint®, the 80-gene molecular subtyping assay, is the only commercially-available test that evaluates the underlying biology of a tumor to determine what is driving its growth. Together, MammaPrint® and BluePrint® provide a comprehensive genomic profile to help physicians make more informed decisions in the pre- and post-operative treatment settings. Agendia develops evidence-based novel genomic tests and forges partnerships with groundbreaking companies to develop next-generation digital treatment tools. The ongoing research builds an arsenal of data that improve patient outcomes and support the evolving clinical needs of patients with breast cancer and their physicians every step of the way, from initial diagnosis to cancer-free. Agendia’s assays can be ordered on core biopsies or surgical specimens to inform pre- and post-operative treatment decisions. For more information on Agendia’s assays and ongoing trials, please visit www.agendia.com. For view our social media policies, please visit https://agendia.com/legal-compliance/






