CENTOGENE GMBH
Job Location :
all cities,MD, USA
Posted on :
2025-07-07T02:03:12Z
Job Description :
Your Responsibilities
- Direct and manage all day-to-day operations of the PGT laboratory
- Ensure full compliance with CLIA and applicable federal and state regulations
- Supervise all technical staff involved in genetic testing procedures
- Validate, implement, and oversee genetic testing platforms such as NGS, array CGH, or qPCR
- Develop, maintain, and enforce Standard Operating Procedures (SOPs), quality control (QC), and quality assurance (QA) protocols
- Review and approve patient PGT results and reports in collaboration with genetic counselors and clinicians
- Participate in clinical case review meetings and provide genetic test interpretation and support to the IVF clinical team
- Manage proficiency testing, audits, inspections, and corrective action plans
- Lead lab personnel training and competency assessments
- Ensure accurate record keeping and data integrity in the laboratory information system (LIS)
- Evaluate and introduce new technologies to maintain a cutting-edge testing program
- Work collaboratively with embryologists to ensure smooth coordination of embryo biopsy and sample workflows
Your profile
- Education: PhD, MD, or equivalent doctoral degree in genetics, molecular biology, or a closely related field
- Licensure/Certification: Must be eligible or currently certified as a High-Complexity Laboratory Director (HCLD) under CLIA; Certification by ABB (American Board of Bioanalysis) or ABMGG (American Board of Medical Genetics and Genomics) strongly preferred
- Experience: Minimum of 5 years of experience in a clinical molecular or cytogenetics lab, with at least 2 years in a leadership or director-level role; Proven experience with PGT, particularly in a CAP/CLIA-accredited IVF or molecular diagnostics laboratory
- In-depth understanding of preimplantation genetic testing technologies and IVF workflows
- Strong knowledge of regulatory and accreditation standards under CLIA
- Excellent leadership and personnel management skills
- Ability to effectively interpret and communicate complex genetic data
- Proficiency in laboratory data systems and quality improvement processes
- Highly detail-oriented with strong documentation and compliance habits
Why us?
- Competitive compensation, including base salary and performance-based bonuses
- Flexible remote work environment
- Opportunity to shape CENTOGENE's strategic expansion into reproductive health
- A mission-driven company with a global impact on rare disease and reproductive care
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