Director, Analytical Development

Overview

Lead analytical development for an innovative cell therapy pipeline addressing serious immune and transplant-related conditions.

You will shape strategy, build a high-performing team, and guide methods from development through GMP manufacturing.

This is an opportunity to combine scientific leadership, hands-on technical expertise, and meaningful patient impact.

The role is fully on-site and offers significant influence in a growing analytical development function.

About our client

Our client is a biotechnology organization developing cell-based therapies designed to address immune disorders and challenges associated with transplantation. Its work combines advanced cell engineering with scalable manufacturing to expand future treatment options. This role will help establish the analytical capabilities needed to advance these therapies toward clinical development and commercialization.

The opportunity (Role summary)

As Director, Analytical Development, you will establish and execute the analytical development strategy for an iPSC-derived cell therapy pipeline. You will lead a small team, partner with Regulatory, Quality, research and development stakeholders, contract development and manufacturing organizations, and contract testing laboratories, and support method development and transfer throughout the product lifecycle.

This is an on-site position with occasional support at external manufacturing or testing partners as needed.

Key responsibilities

• Lead analytical strategy, priorities, roadmaps, and risk-based assay plans.
• Manage, recruit, train, mentor, and develop Analytical Development staff.
• Build analytical methods and potency testing strategies for cell therapy products.
• Execute laboratory-based analytical development activities as needed.
• Oversee SOPs, test methods, development reports, qualifications, and supporting procedures.
• Transfer in-process, release, and characterization methods to external manufacturing and testing partners.
• Resolve complex quality-control testing issues during clinical production.
• Develop and approve analytical source documents and support CMC regulatory submissions.
• Partner with Regulatory teams on agency responses and analytical strategies.
• Evaluate and select external testing and manufacturing partners.
• Drive continuous improvement, operational excellence, and analytical capability development.
• Support budgets, resource forecasts, capital planning, and departmental business cases.

What you’ll bring

• A bachelor’s degree plus 15+ years, master’s degree plus 13+ years, or PhD plus 10+ years of biotechnology or pharmaceutical industry experience.
• Cell and gene therapy experience, ideally involving iPSC-derived products.
• At least 7 years of people-management experience.
• Expertise in potency assays, flow cytometry, product characterization, RT-PCR, and ddPCR.
• Experience developing, optimizing, qualifying, and transferring analytical methods.
• Knowledge of endotoxin, mycoplasma, sterility, rapid release, stability, shelf-life, and specification-setting strategies.
• Experience managing external manufacturing and testing partners and supporting CMC filings.
• Strong problem-solving, communication, technical writing, presentation, collaboration, and negotiation skills.
• Preferred experience with whole genome sequencing, bioinformatics pipelines, or single-cell RNA sequencing.

Compensation & benefits

This role offers a base salary range of $185,000–$240,000 , depending on experience.