Director, Analytical Development (Cell Therapy)

Location: Cambridge, Massachusetts, United States; this role is based at the Thymmune location.

Salary: $185,000–$240,000 per year.

Company

hirify.global is a public benefit biotechnology and pharmaceutical company developing therapies for rare diseases and technologies intended to expand the availability of transplantable organs. Thymmune, a subsidiary, develops a machine learning-driven iPSC-thymic cell engineering platform and a pipeline of cell therapies for immunodeficiencies, transplant-related diseases, and autoimmune disorders.

What you will do

• Lead the analytical development strategy, priorities, roadmap, and potency testing approach for iPSC-derived cell therapy products.
• Manage, mentor, and develop the Analytical Development team while allocating resources to meet departmental and program milestones.
• Oversee assay development, optimization, qualification, transfer, SOPs, test methods, reports, and procedures supporting GMP manufacturing and QC testing.
• Lead technology and knowledge transfer for in-process, release, and product characterization methods to CDMOs and contract testing laboratories.
• Provide technical leadership for QC issues during clinical production, including person-in-plant support, and contribute to CMC regulatory submissions and agency responses.
• Support CDMO and contract testing laboratory selection, budget planning, resource forecasting, continuous improvement, and cross-functional analytical strategy.

Requirements

• 10–15+ years of biotech or pharmaceutical industry experience depending on academic degree, preferably in cell and gene therapy, plus 7+ years of managerial experience.
• Bachelor’s, master’s, or PhD degree in biological sciences, immunology, cell biology, biomedical engineering, or biochemical engineering.
• Technical expertise in cell therapy analytical methods, including potency assays, flow cytometry-based assays, and product characterization.
• Experience developing, optimizing, qualifying, transferring, and managing analytical methods, stability studies, specifications, and shelf-life programs under regulatory and ICH guidelines.
• Hands-on experience with flow cytometry, RT-PCR, ddPCR, safety assays such as endotoxin, mycoplasma, and sterility testing, and rapid release tests.
• Experience working with CDMOs and contract testing laboratories, CMC regulatory filings, technical writing, troubleshooting, and cross-functional collaboration.

Nice to have

• PhD or master’s degree in a relevant biological science or engineering discipline.
• Experience developing and qualifying analytical methods for iPSC-derived cell therapy products.
• Experience with whole genome sequencing, bioinformatics pipelines, and single-cell RNA sequencing.

Culture & Benefits

• Purpose-driven work focused on rare-disease therapies, immune disorders, and transplant medicine.
• Medical, dental, vision, prescription, wellness, disability, and savings plan benefits for eligible employees.
• 401(k), employee stock purchase plan, paid time off, and paid parental leave.
• Environment emphasizing scientific leadership, innovation, accountability, teamwork, and continuous improvement.