Head of Quality and Analytical Development, Cell Therapy

We are currently hiring someone to be responsible for Quality and Analytical Development for our iPSC-derived cell therapy programs. In this role, you will lead our analytical development and the establishment of our quality unit to support in-house cGMP manufacturing. You will be the first person in this function and will report to the CEO.

About you:

You are a driver and a doer; someone who identifies the unknowns and then gets to work on solving for them. You effectively bring people together, create buy-in, and optimize cross-functional workflows. You are excited by the “first-in-function” challenge and are energized by building new processes and rapidly iterating to optimize them. You’re optimistic about our ability to positively impact the human condition and extend healthy human lifespan.

In this role you will:

• Collaborate with program leads to align research and quality control, working together to define key product-quality attributes and critical process parameters.
• Develop and validate analytical protocols for our cell therapies per ICH guidelines, ensuring analytical rigor (e.g., flow, qPCR, ddPCR, and ELISA).
• Drive selection and roll out of an electronic Quality Management System (eQMS) tailored to cell therapy manufacturing, including documentation, training, and audit processes.
• Write and implement SOPs for activities under cGMP.
• Oversee the qualification and validation of equipment, instruments, and manufacturing processes (IQ/OQ/PQ) to ensure they meet cGMP standards.
• Review and approve quality system records including change requests, deviations, and CAPA as necessary.
• Train staff on SOPs, track compliance, identify risks, and foster a culture of quality in manufacturing.
• Sign off on Certificates of Analysis (CoA) for produced batches, guaranteeing product quality.
  Support regulatory submissions, including IND, pre-IND, and BLA filings, with a focus on CMC and quality sections.

You might thrive in this role if you:

• Have a minimum of 8 years of experience leading quality and analytical development functions in the cell therapy space.
• Have experience in analytical assay development including cell-based assays, flow, qPCR, ddPCR, and ELISA.
• Possess deep knowledge of cGMP regulations, ICH, 21CFR11, and other relevant regulatory requirements.
• Have experience setting up standards for QA/QC ensuring consistency across therapeutic products.
• Have experience with autologous and/or allogeneic iPSC-derived therapies.
• Have experience in leading and building high performing teams.

You are energetic, detail-oriented, intellectually curious, and deeply pragmatic. You thrive in a culture that embraces rapid iteration and open, straightforward communication.

$160,000 – $230,000 a year

Total compensation also includes generous equity and benefits including:

– Medical, dental, and vision insurance for you and your family
– 401(k) plan with 4% matching
– Flexible time off and 10 company holidays per year
– Paid parental leave
– Annual learning & development stipend
– Daily Retro-sponsored lunch and snacks