CLIA Lab Scientist
Clinical Laboratory Scientist
Milagen is a privately held, late-stage, pre-commercial diagnostic company focused on commercializing easy-to-use, non-invasive, in vitro diagnostic (IVD) products designed to fulfill unmet clinical needs in the prevention, detection, diagnosis, and management of major cancers. Milagen is currently seeking certification & accreditation of its Clinical Laboratory Improvement Amendments (CLIA) Laboratory in order to offer its proprietary Laboratory Developed Test (LDTs ) service for early recurrence monitoring of breast and colon cancer.
We are currently hiring for a clinical laboratory scientist (CLS) to join our independent clinical lab and perform LDTs on serum for monitoring cancer recurrence. The CLS participates in data collection and analysis, implementation of laboratory policies and procedures, and maintenance of laboratory equipment; and performs other duties as assigned. This is a part-time job with possibility to convert to a full-time job. The CLS will be reporting to the Laboratory Clinical Director or equivalent.
- Perform analytical testing on serum, utilizing both manual and automated methods, to obtain information necessary for monitoring the recurrence of cancer. Where automated methods are used, this position provides preventive maintenance for analytical equipment.
- Independently perform clinical testing (e.g., ELISAs) in accordance with established standard operating procedures.
- Assist in document control reviews, as required.
- Execute validation studies to assess technical test performance in accordance with CLIA regulations and guidelines.
- Demonstrate problem-solving skills and analytical abilities to successfully perform laboratory testing.
- Adhere to established laboratory policies in areas of procedures, quality control, quality assurance, and safety.
- General knowledge of state and federal regulations pertaining to the operation of a clinical laboratory.
- Management of laboratory assistants and other duties as assigned.
- BS Degree in clinical laboratory or related sciences (required)
- Valid CA CLS License (required) to perform high complexity testing
- Minimum of 1 year of experience in a clinical laboratory setting; preferably with experience in a high complexity testing environment. Experience in immunoassay techniques preferred.
- Strong analytical and organizational skills
- Strong background in laboratory techniques
- Strong ability to pay attention to details.
- Excellent written and oral communication skills.
- Must work effectively with an interdisciplinary team of scientists, physicians, lab technologists and be solutions-oriented.
Milagen is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.