Clinical Lab Innovator & Study Lead

Planet Pharma; Franklin Lakes (NJ); On-site; USD 55,000 - 62,000; Full time

Job summary

Planet Pharma is seeking a laboratory-based professional to input in design, evaluation, and reporting for safety and efficacy of in-vitro diagnostic devices. The role involves handling human blood in clinical lab disciplines and operating multiple instrument platforms, with a strong focus on quality and regulatory standards.

Responsibilities include developing new testing methodologies with R&D, performing clinical testing, maintaining instruments, and mentoring new associates.

Qualifications

• BS/BA/MA in Clinical Laboratory Science or Medical Technology is required.
• MT/MLT CLS (ASCP) or equivalent experience in a research environment preferred.
• 5+ years of experience in a clinical laboratory environment with strong quality/regulatory exposure.

Responsibilities

• Provide input to design, evaluation, execution and reporting for safety and efficacy of in-vitro diagnostic devices.
• Develop/implement new testing methodologies in collaboration with R&D.
• Conduct clinical testing and maintain instrumentation/reagents per priorities.
• Implement QA/QC procedures and document instrument performance per CLSI guidelines.
• Train new associates on laboratory workflow and support investigations for customer complaints.

Skills

Clinical laboratory science

GCP/GLP awareness

Excellent communication

Phlebotomy

Blood collection products

Quality/Regulatory knowledge

Problem solving

Computer skills

Project planning

Education

BS/BA/MA in Clinical Laboratory Science or Medical Technology

MT/MLT CLS (ASCP) or equivalent

Job description

Planet Pharma is seeking a laboratory-based professional to input in design, evaluation, and reporting for safety and efficacy of in-vitro diagnostic devices. The role involves handling human blood in clinical lab disciplines and operating multiple instrument platforms, with a strong focus on quality and regulatory standards.

Responsibilities include developing new testing methodologies with R&D, performing clinical testing, maintaining instruments, and mentoring new associates.