You will work directly with the VP of Global Operations and will play an integral role in building out the GMP reagent manufacturing capabilities at our Dallas-Fort Worth laboratory. You will act as the interface between our contract manufacturers, contract laboratory partner, and internal Quality Control laboratory to ensure a steady supply of reagents for use in our single-site IVD assay. The role spans manufacturing, validation, and supply chain. You will lead a team interfacing with our Assay Development, Quality, and Finance functions to establish processes for release of reagents, inventory management, and equipment qualification. The Sr. Director, MSAT & Supply Chain will be an expert at reagent manufacturing (formulation, reformatting, and kitting) and successfully implement a manufacturing program that allows us to scale from development to commercialization. This individual will be responsible for sufficient, consistent, high-quality reagent production and release to meet demand.
You will be part of a team that is passionate about developing novel diagnostic tests for the early detection of cancers. As part of the team, you will be in a Company that aims more than to become one of the leaders in the industry. We want to have a huge positive impact on society by achieving the ambitious purpose of "making cancer a curable disease by detecting it earlier".

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.

How you'll contribute

• Lead, direct and monitor every aspect of reagent manufacturing with strong cross-functional leadership, across in-house and contracted manufacturing sites.
• Ensures production processes are adequately developed, documented, and performed in compliance with company procedures and external regulatory requirements.

• Build reagent operations strategy and roadmap including required capex, facilities strategy, organization, IT systems, regulatory impact, and business processes.
• Supervise manufacturing planning, scheduling, quality adherence, processing, materials management, and packaging.
• Ensure production schedules and support activities are aligned
• Responsible for effective planning and allocation of resources to meet demand
• Monitor and optimize production/manufacturing performance through transparent KPIs and foster a culture of continuous improvement
• Assess, develop and execute business strategies and practices to constantly improve production capability and capacity, quality, costs and customer satisfaction
• Collaborate closely with the Assay Development team and other cross-functional teams to facilitate and enable smooth transition of reagents from bulk to kitted to support automation
• Ensure compliance with ISO13485, successful annual audits and recertifications
• Hire, train, motivate, evaluate and develop to retain a fully engaged, talented workforce
• Ensure strong performance management and succession planning.

What you'll bring

• A positive self-driven attitude, capable of figuring out what needs to be done and making it so.
• Experience working in a medical device regulated market. Preferably with NGS instrumentation and reagents, but other diagnostic systems background will be considered (QSR, CE-IVDR, FDA, ISO13485, ISO14971).
• Data-driven, knowledge and decision making through operational metrics and analytics
• Demonstrated ability to deliver on time, on budget in a fast-paced lean environment
• Excellent interpersonal and communication skills to interface, negotiate and influence multi- disciplinary teams with different levels of personnel
• Ability and willingness to travel 10% of the time, domestically.

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