About the Role
- Identify the best location for setting up the new CLIA laboratory.
- Negotiate with the landlord on a lab space lease, preferably with an existing lab layout.
- Review lab layout and contracting building/renovation as may be necessary to meet CLIA standards.
- Source all required equipment
- Help screen, interview, and recruit the best Laboratory Director and clinical laboratory scientist candidates.
- Work with the Laboratory Director and/or consulting firm to adjust technical and general standard operating procedures and guidance to Genetika+ operation and testing.
- Coordinate the selection and implementation of a Laboratory Information Management System (LIMS).
- Oversee the clinical validation studies required for application submission
- Work with the Laboratory Director and/or consulting firm on MA state application, followed by all out-of-state and CMS-CLIA applications.
- Ensure the lab and the team is ready for inspection
- Obtain all state, out-of-state, and CLIA licenses and certifications.
- Partner with the management team to identify continuous improvement opportunities and new processes or systems implementations.
- Ensures an OHSA system is in place within all aspects of the business that complies with applicable regulations.
- Screen, interview and contract a medical billing vendor
- Define the necessary work effort in order to begin testing – going live.
- Work with Finance to establish a long term capacity and productivity plan.
- Work with internal and external groups to investigate the cause of and resolve key technical issues.
- Support the development and execution of the strategic plan.
- Oversee the Technical Services function responsible for method development, validation, troubleshooting, facility/equipment maintenance and Laboratory Analyst training.
- Provide technical review of key development documents which will be provided to customers and/or regulators.
- Develop implementation strategies to ensure compliance with emerging state and regulatory agency compliance requirements.
- Establish and maintain productive working relationships with people inside the laboratory and people outside the laboratory including customers, regulatory staff and corporate staff.
What We Expect Of You?
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, and/or abilities required.
BS degree in Biology / Chemistry or related science with 10 + years of management experience; or
3+ years’ experience in the management of laboratory operations
Experience in setting up new CLIA laboratories
Experience in operating high complexity CLIA laboratory
Experience in cell-based and imaging testing
Passion for both hands-on work and management-based responsibilities
Excellent verbal and written communication skills to facilitate collaboration between colleagues in scientific and non-scientific roles
Knowledge, Skills, and Abilities:
Pragmatic self-starter who can manage self, motivate others, and operate effectively in a constantly changing environment
Ability to look at the big picture
Well-founded formal problem-solving skills. Experience in solving challenging operating and technical issues
Ability to work effectively in collaboration with diverse groups of people
Time management skills to handle a variety of assigned tasks simultaneously
Ability to communicate with other departments as a technical representative to assist in process improvement, customer inquiries, staff training as needed
Well-developed written skills to prepare license applications, routine management reports, as well as preparing presentations to a variety of audiences
About the Company
How might you impact healthcare?
Genetika+ is a well-funded, award-winning, fast-growing company with the mission of improving patient outcomes in Major Depression. Genetika+ has developed a truly personalized medical test, a unique blood assay that optimizes depressed patients’ care through enabling, for the first time, the identification of the right medication for each patient.
What You Will Do?
This position is responsible for the establishment and overall management of the Laboratory Operations at the New Jersey location. Responsibilities include identifying the new lab location, managing contracting, building infrastructure, obtaining resources & staffing, achieving state license and CMS CLIA, and overseeing the day to day operations of the laboratory. Upon launch, accountability includes regulatory compliance, policy & procedural compliance, oversight of technical issues relating to tests conducted, maintaining the required turnaround time, and meeting expectations relating to quality.