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Manager/Director of Laboratory Operations

Employer
Functional Fluidics
Location
Detroit, Michigan, US
Salary
Competitive
Closing date
Jan 15, 2022

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Are you a life sciences professional with expertise as an Operations Manager who thrives in a fast-paced startup environment? If yes, please read on!

About Functional Fluidics

Functional Fluidics is a high complexity CLIA-certified diagnostic lab. Their mission is to be the gold standard in red blood cell health starting with Sickle Cell Disease. Their suite of assays is currently offered nationally to clinical providers, pharmaceutical, academic and biotech partners to support drug development and patient care.

Functional Fluidics is generating both Contract Research and clinical testing revenues and is expanding both the footprint of their services, and the scope of assays in both LDTs and medical devices applications.

About the position

In this role, you will be responsible for standard operational duties, and bring an understanding of a biotechnology company that runs a CLIA certified lab conducting clinical assays as well as doing contract research and performing internal R&D.

Responsibilities:

You will work with a top notch leadership team and will be able to grow with the company. Job duties will include:
  • Oversee daily laboratory procedures
  • Monitor work performed by lab technicians to generate medically reliable data and test results
  • Participate in validations, projects and monitoring of routine KPI's
  • Verify accuracy of documentation
  • Demonstrate understanding of established Code of Federal Regulations (CFR) and company SOP's, to ensure blood components meet safety, purity, and potency requirements
  • Design/maintain complex financial management and forecasting systems for expenditure and budgeting purposes.
  • Design & implement allocation schemes & standard operating procedures for group
  • Oversee purchasing, maintenance, tagging, tracking of lab equipment
  • IT management including maintenance of group web pages, upkeep of software & computer systems
  • Provide expert technical advice and assistance to State Agency staff performing CLIA surveys & other work pertaining to CLIA


About You

The ideal candidate is a life sciences professional with the following skills
  • MLS (ASCP) or equivalent experience
  • Knowledge of state and federal laws, rules & regulations, voluntary accrediting standards related to the operation of clinical laboratories
  • Knowledge of laboratory processes, inventory requirements, and quality systems
  • Ability to successfully lead laboratory staff
  • Is highly organized with excellent project management skills
  • Familiar with biotechnology companies that run CLIA certified labs
  • Experience as an Operations Manager with skills in purchasing, logistics, & human resources
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