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 reagent development, quality assurance, and manufacturing teams to support the development and commercialization of IVD tests. You will interact with internal stakeholders and vendors to ensure IVD reagent development, manufacturing, and process validation activities are aligned with IVD program timeline and goals. You will play a critical role in IVD reagent development and manufacturing workstreams in 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 reagent development/manufacturing and support the development and commercialization of new IVD products.
· Work closely with team leads, cross-functional teams, vendors, 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 or engineering field (e.g., Biology, Chemistry, Biotechnology, Engineering or a related discipline) with 4-6 years of project management and/or program management experience. Experience with reagent development, manufacturing, and/or process validation in the life sciences required; IVD-specific experience highly preferred.
· Must have experience working with vendors and external stakeholders
· Experience with regulated environments and a strong working knowledge of 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.
· Prior experience with project management tools and methods, previous experience using Smartsheet and MS office a plus.
· Excellent communication and teamwork skills with the ability to facilitate and collaborate across departments and vendors/external stakeholders effectively.
· Ability to organize teams working remote in different time zones.
What We´ll Offer
- Relocation support to the DFW area
- Flexible work schedule
- 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.
What We´ll Offer:
We’re proud to offer exceptional corporate benefits which include:
- Relocation support to the DFW area for on-site roles.
- Flexible work schedule
- 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….