Senior Manager, Laboratory Operations

Location: South Plainfield, New Jersey, United States of America

Do you have an entrepreneurial spirit? Do you have experience managing and building regulated labs? If so, we encourage you to apply to become the Laboratory Operations Manager for our Preclinical and Clinical Services laboratory. In this role, you will be responsible for the day to day operations in our GLP and CLIA/CAP accredited lab ensuring timely project deliveries, compliance with regulatory standards, proper training of staff, and ensuring equipment/reagents are in good standing. This role reports directly to the Director of Clinical Development Services.

Title:                      Senior Manager, Laboratory Operations

Location:              South Plainfield, NJ

Responsibilities:

  • Direct line manager for our genomics operations team
  • Ensuring all personnel are trained and adhering to laboratory procedures
  • Ensuring timely delivery of client project
  • Ensuring instrumentation is functioning properly, maintenance is being performed and associated documentation is complete and reviewed in a timely manner
  • Work closely with development teams to implement process improvements
  • Define and track KPIs
  • Collaborate closely with our Quality Assurance team
  • Attend and lead sections of client/regulatory body audits
  • Comfortable working in and evolving LIMS systems

Qualifications:

  • MS (required), PhD or equivalent (preferred) in the biological sciences
  • 5+ years of experience in a regulated laboratory environment supporting GLP/GCLP and/or CLIA/CAP molecular
  • 2+ years managing a regulated laboratory  
  • Deep expertise in multiple molecular biology workflows including but not limited to NGS, qPCR, and Sanger sequencing
  • Highly organized with great attention to detail
  • Results oriented with a continuous improvement mindset
  • Proficiency in MS Office365 including Word, Excel, PowerPoint
  • Proficiency coding in any language is preferred

EOE M/F/Disabled/Vet