Laboratory Program Manager
Universal Diagnostics
About our Company:
Universal DX, Inc. is an international Company with a highly experienced team focused on cracking cancer’s code. Through our multi-omics and bioinformatics models, we have figured out how to read the disease’s signals in blood with high accuracy to detect cancer in its earliest stages. Starting with a colorectal cancer screening liquid biopsy test, we are building a multi-cancer platform that can identify the unique DNA regions associated with different types of cancers.
The Opportunity:
Universal DX is seeking an experienced program manager to join our growing team. You will report to the Director, Program Management and work closely with the laboratory operations team to support our Dallas-based laboratory. You will interact with our quality assurance, compliance, and IT teams to support the laboratory, as well as work closely with our IVD product development team to support the necessary projects and studies conducted in the laboratory. You will play a critical part in the laboratory readiness and product development workstreams that will support the design and development of Universal DX’s screening test for colorectal cancer.
As the program manager, you will:
· Strategize, implement, and maintain program initiatives to achieve organizational goals related to laboratory readiness and support the development and commercialization of new IVD products.
· Work closely with team leads, cross-functional teams, and assigned PMs to develop the scope, deliverables, required resources, work plan, budget, and timing for existing and new initiatives.
· Track execution and project team’s accountability for delivering against established timelines and objectives.
· Analyze, evaluate, and escalate program risks and provide program reports for management and stakeholders
· Work with other program managers to coordinate cross-functional activities, identify risks and opportunities across multiple projects within the company.
What you will bring:
· Bachelor’s degree, ideally in a scientific field (e.g., Biology, Chemistry, Biotechnology, or a related discipline) with 4-6 years of project management and/or program management experience. Experience with IVD development preferred.
· Prior experience with project management tools and methods, previous experience using Smartsheet and MS office a plus.
· Experience with regulated environments (CLIA, CAP, GMP) and familiarity with medical device regulatory requirements (e.g. 21CFR812, ISO 13485, etc.)
· Strong organizational, problem-solving, and multitasking skills, with the ability to manage multiple priorities in a fast-paced setting.
· Excellent communication and teamwork skills with the ability to facilitate and collaborate across departments effectively.
· Ability to organize teams working remote in different time zones.
What we´ll offer:
· Flexible work schedule
· Relocation assistance
· Accrued time off
· Company-sponsored benefit plans which include Paid Time Off, Medical, Dental, Vision, 401(k)
· Free day on your birthday
· And more to come…
Why Now?
This is an exciting time to be at Universal DX. We are growing rapidly and starting our US operations by building up our team, starting our lab and business operations, and establishing strategic partnerships.
We are looking for passionate changemakers to be a part of our journey in this expansive time for us.