Adela is focused on the detection of cancer and other high-morbidity, high-mortality conditions through a blood test. The Company’s genome-wide methylation analysis technology has the unique ability to distinguish the most-highly informative (methylated) regions of the genome from the non-informative regions and preferentially target those informative regions for sequencing. The technology is initially being developed for use across the cancer continuum for detection, diagnosis and management and in the future will be applied to other conditions beyond cancer.
We are seeking a highly motivated individual to join the Adela Team as Laboratory Information Management Systems (LIMS) Manager. This is an exciting opportunity to be part of a growing, dynamic, and collaborative biotech company leveraging cutting-edge liquid biopsy technology. This newly created role will report directly to the Chief Operating Officer and will be responsible for overseeing all activities related to regulatory compliance, support, validation, troubleshooting of the LIMS as well as implementation, administration, training, and guidance of the lab staff in the use of the LIMS. In this hands-on role, the incumbent will actively manage LIMS architecture, configuration, and support of the LIMS related applications. The LIMS Manager will work closely with stakeholders to identify and implement solutions in the LIMS that support laboratory workflows whereby achieving business goals and objectives. Adhering to Adela’s change management procedures, the Manager will work closely with internal IT and external 3rd parties to maintain current software versions and make recommendations and coordinate upgrades to the LIMS, its supporting applications, and hardware.
· Lead the implementation strategy of the new LIMS into Adela. Coordinates all UAT activities, prepares acceptance criteria in collaboration with laboratory end-users at Adela locations in the New Haven, Connecticut and Toronto, Ontario, CANADA
· Serve as a hands-on manager that will actively participate in technical activities and manage team members.
· Provide operations support to end users and provide guidance in the implementation of new LIMS functionality.
· Work closely with laboratory personnel, vendors and other IT professionals to understand the needs of the laboratory staff and clients, configure and maintain LIMS in a manner that addresses those needs and maximizes the system's efficiency and performance.
· Monitor performance health of the LIMS and coordinates with vendor any requirements for system maintenance.
· Create and execute computer system validation documents (i.e. UAT, URS, OQ, PQ, etc.) under CLIA, CAP, FDA and ISO regulations
· Create and maintain LIMS related SOPs to direct end users on using the system in compliance with appropriate regulatory agencies.
· Serve as technical point of contact for troubleshooting, addition of new instruments and/or workflows into the LIMS and adding new end users.
· Work closely with the laboratory leadership and project management teams to ensure the successful execution of projects
· Ensure LIMS data are available, secure, and maintained
· Establish procedures that effectively secure the LIMS and related applications and actively mitigates potential security risks.
· Ensure the data and applications are protected according to the company’s disaster recovery policies.
· Travel to Adela laboratory locations to install upgrades, new instruments/workflows, troubleshoot issues, and perform upgrades as needed.
· Hire and retain team in support of LIMS as Adela’s business grows
· Create, monitor, and document achievable goals and metrics for team members
· Other Duties & Responsibilities as assigned
· Hands-on experience configuring and maintaining commercial LIMS platforms.
· Experience with database reporting software applications
· Working knowledge of cloud technologies; for example, Amazon’s Web Services.
· Demonstrated experience in process and software validation, including FDA, CAP and CLIA.
· Proven knowledge in system testing, validation, problem resolution, and training
· Background in laboratory computing environment including instrument and system interfaces and familiarity with laboratory procedures
· Working knowledge of the regulatory environment
· Strong written and verbal communication skills across different and diverse groups or individuals
· Ability to establish and maintain effective working relationships across the organization
· Ability to work under pressure and troubleshoot problems
· Excellent analytical and problem-solving skills
· Extensive experience in application testing
· Ability to explain technical details to non-technical staff
· Solid understanding of business practices with fundamental understanding of project management methodology