Head of Quality and Analytical Development, Cell Therapy

Retro develops therapies for diseases driven by the biology of aging. We focus on cellular reprogramming and autophagy to rejuvenate cell and tissue function with the ultimate aim of adding 10 years to healthy human lifespan.

We’re building a mission-driven team of accomplished and kind individuals who embrace our startup culture of rapid iteration, transparency, and versatility. 

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.

• Develop and implement 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.
• Collaborate with program leads to align research and quality control, working together to define key product-quality attributes and critical process parameters.
• 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.
• Develop and validate analytical protocols for our cell therapies per ICH guidelines, ensuring analytical rigor (e.g., flow, qPCR, ddPCR, and ELISA).
• 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.

• 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.

We take pride in cultivating an environment that fosters collaboration, open communication, and authenticity. We believe that great results are best delivered by a highly creative team working in concert. We are an equal opportunity employer; we do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. We are diverse in background and singular in mission.