Director Analytical Development

California, US residentsclick here.

The job details are as follows:

Who We Are

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 at scale. The company is developing a pipeline of therapies to treat immunodeficiencies, transplant related, and autoimmune diseases.

Who You Are

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 at CDMOs. Provide 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 support organizational objectives and long-term departmental capabilities
• Perform all other duties as assigned

Minimum Requirements

• 15+ years of biotech/pharma industry experience preferably in cell and gene therapy with a Bachelor's Degree in biological sciences, immunology, cell biology, biomedical or biochemical engineering or 13+ years of biotech/pharma industry experience preferably in cell and gene therapy with a Master’s Degree in biological sciences, immunology, cell biology, biomedical or biochemical engineering  or 10+ years of biotech/pharma industry experience preferably in cell and gene therapy with a PhD in biological sciences, immunology, cell biology, biomedical or biochemical engineering
• 7+ years of previous managerial experience
• Technical expertise in cell therapy analytical methods, such as potency assays, flow cytometry-based assays, and product characterization assays
• Experience in analytical method development, optimization, qualification, and transfer, in accordance with regulatory guidelines and industry standards
• Hands-on experience in the characterization of cell therapy products using methods such as flow cytometry, RT-PCR, and ddPCR
• Knowledge of safety assays required for lot release such as endotoxin, mycoplasma, and sterility, including rapid release tests
• Expertise in analytical control strategies including specification setting
• Experience in setting and managing stability studies per ICH guidelines and establishing shelf life for drug substance and drug product
• Experience with cell-based potency assay development and defining potency testing strategy for cell therapy products
• Experience establishing and managing interactions with CDMOs and CTLs
• In-depth understanding of regulatory guidelines and experience with CMC regulatory filings
• Excellent analytical and problem-solving skills, with a strong ability to troubleshoot critical issues or problems
• Excellent communication, technical writing, and presentation skills
• Ability to work hands-on with a high sense of urgency, accountability, and focus on delivering results
• Exceptional teamwork and interpersonal skills with the ability to motivate others, influence, and negotiate difficult situations
• Strong attention to detail and demonstrated ability to collaborate effectively on cross-functional teams and within a dynamic environment

Preferred Qualifications

• Doctor of Philosophy (PhD) in biological sciences, immunology, cell biology, biomedical or biochemical engineering or Master’s Degree in biological sciences, immunology, cell biology, biomedical or biochemical engineering
• Knowledge and experience in developing and qualifying analytical methods for iPSC derived cell therapy products
• Experience with whole genome sequencing methodologies, bioinformatics pipeline, and scRNA Seq

The salary range for this position is $185,000.00 - $240,000.00 and reflects our good-faith estimate of the compensation for this role at the time of posting. An employee’s position within the salary range will be based on factors such as education, qualifications, experience, skills, geographic location, and business needs, as well as other factors permitted by law at the time of posting. This range may be modified in the future based on company and market factors.

Location

This role is based in our Cambridge, MA Thymmune location.

Eligible employees may participate in the Company’s comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities

United Therapeutics  Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.