Director, Analytical Development

United Therapeutics Corporation•Cambridge, MA

1d•$185,000 - $240,000•Onsite

About The Position

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.

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

Nice To Haves

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

Responsibilities

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