Director, Analytical Development

California, US residents .

We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs. United Therapeutics (Nasdaq: UTHR) seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases.

We were founded in 1996 by a family seeking a cure for their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF). The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need.

For this reason, we are working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option. Thymmune, a United Therapeutics subsidiary, is a biotechnology company developing a machine learning-driven thymic cell engineering platform to restore normal immune function in aging and disease.

The company's cutting-edge approach in iPSC-thymic cell manufacturing can generate off-the-shelf cells  company is developing a pipeline of therapies to treat immunodeficiencies, transplant related, and autoimmune diseases.

Some people develop assays. Others help build the future of medicine. At Thymmune, you'll do both. As our Director of Analytical Development, you'll lead a high-performing team, shape analytical strategy for a pioneering cell therapy pipeline, and help advance technologies that could redefine how we treat immune disorders and expand the possibilities of transplant medicine. This is a rare opportunity to combine scientific leadership, innovation, and purpose in an environment where bold ideas are encouraged and meaningful impact is expected every day.

The Director, Analytical Development will be leading Thymmune's analytical development strategy to support Thymmune's iPSC derived cell therapy pipeline. This role will define and execute analytical development and method transfer activities to enable iPSC expansion and differentiation in GMP manufacturing throughout the product lifecycle. Lead the strategy, priorities, and roadmap for analytical development and develop phase-appropriate and risk-based analytical assays and potency testing strategies to support Thymmune's pipeline of iPSC-derived cell therapy products Recruit, manage, train, motivate, develop, and mentor Analytical Development staff Provide leadership, direction, and resource allocation for analytical development activities to ensure achievement of departmental objectives and program milestones.

Execute analytical development work and perform assays in a laboratory setting, as necessary Oversee and perform the development, authoring, review, and approval of SOPs, test methods, method development reports, and supporting procedures for analytical method development and qualification in support of GMP manufacturing and QC testing Act as an SME for analytical development and lead knowledge and technology transfer strategy and execution for in-process, release, and product characterization methods to CDMOs and CTLs Provide strategic and technical leadership to resolve complex QC testing issues during clinical production vide person-in-plant support, as needed Develop, review, and approve analytical development source documents, and provide oversight for relevant CMC sections for regulatory submissions.

Support the Regulatory group in responding to agency questions and influence analytical strategies supporting regulatory submissions and agency interactions Lead due diligence, evaluation, and selection activities for Contract Testing Labs (CTLs). Actively participate in due diligence exercise for CDMO selection Ensure the team stays up to date with current technologies and trends, driving continuous improvement, operational excellence, and the advancement of analytical development capabilities Support budget planning, resource forecasting, and capital requirement planning for the Analytical Development function, including developing business cases and recommendations to support departmental and organizational priorities Establish and execute the strategic direction, priorities, and resource plans for the Analytical Development function, partnering cross-functionally with Regulatory, Quality, CDMOs, CTLs, and other R&D stakeholders to…