Job Title: Laboratory Manager
Overview:
Datar Cancer Genetics is a leading organization in the field of cancer diagnostics, developing breakthrough liquid biopsy technologies for cancer detection and management. Early diagnosis of Cancers can have curative treatment options aiming for excellent survival rates. Datar Cancer Genetics intends to bring liquid biopsy-based early cancer detection technologies to public use post-regulatory approvals in the United States.
The Laboratory Manager requires critical laboratory management expertise to bring such technologies into a commercially approved device and is responsible for overseeing laboratory operations, training, planning, team building, and communicating with management. He/She will be responsible for adherence to Quality Systems in compliance with regulatory standards such as GLP, 21CFR (part 11, part 820) and ISO15189, etc.
As the Laboratory Manager reporting to the Director Laboratory, you will implement, manage and improve QMS per regulatory requirements and guidelines to support US-FDA premarket authorization clinical studies. This role is based out of our facility at Morrisville, NC, and may require travel when necessary.
Job Description,
- Work at the bench to train staff on executing laboratory workflows of clinical diagnostic assays.
- Ensure that all work in the laboratory is performed according to the Standard Operating Procedures (SOPs) and that all Unit staff are trained in and perform duties according to SOPs.
- Provide day-to-day monitoring of safety issues for all activities in the laboratory and ensure compliance with all safety regulations (OSHA).
- Ensure compliance to the Laboratory quality management system (QMS) according to the ISO15189, CFR 21 part 820 and CLIA including other laboratory and regulatory standards as applicable.
- Manage and supervise technical staff including recruitment, training, performance management, and professional skills development
- Advise on and troubleshoot technical procedures, techniques and equipment, and maintain conformance with specific operational standards
- Coordinating the work of other testing staff in the department; prioritizing, assigning, and reviewing work; Notifying management of problem areas or issues in the laboratory
- Send daily, weekly and monthly productions reports to management
- Determine the acceptability of specimens for testing according to established criteria
- Ensure accurate and timely test results in order to deliver quality patient care
- Maintain a safe work environment and wear appropriate personal protective equipment
Qualifications
- Masters in Biology, Molecular Biology, Biotechnology, Microbiology, Biochemistry, Genetics, Medical Technology, or relatable life science
- Must have a minimum of 7 years of experience in a Clinical Diagnostic Lab setting (5 years at the Technologist level)
- Proficient with Laboratory Information Systems and Microsoft Office
- High level of attention to detail with strong organizational skills
- Must be able to work in a team environment, be well-organized and have strong computer and communication skills; both written and verbal
Job Type: Full-time
Pay: $50,000.00 - $60,000.00 per year
Benefits:
- Dental insurance
- Health insurance
- Paid time off
- Vision insurance
Schedule:
- 8 hour shift
- Day shift
- Weekend availability
Ability to commute/relocate:
- Morrisville, NC 27560: Reliably commute or planning to relocate before starting work (Required)
Experience:
- Clinical Diagnostic Technician: 5 years (Preferred)
Work Location: In person
