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 a Process Development Lead in cell therapies. As our first team member focused on process development, you will lead our process development efforts from optimization through GMP-compliant manufacturing. You will report to the lead of our Microglia Therapeutic program, however, you will work on process development for multiple programs.
You:
You are experienced in process development, specifically in cell therapies, and have worked on multiple protocols at the same time. You have worked hands-on with wet lab teams to learn the ins and outs of their protocols and know how to scale them successfully. You value quick iteration and direct communication, knowing they enable our team to move fast while staying aligned. You are excited to be a part of Retro’s mission and fundamentally improving the human condition.
In this role, you will:
- Develop, optimize, scale up and/or scale out bioprocesses for cell therapy products, with a focus on bioreactors, induced pluripotent stem cells (iPSCs), and differentiation protocols.
- Collaborate closely with our R&D teams to uptake processes from research to process development, ensuring seamless integration and scalability.
- Collaborate with manufacturing to transfer the optimized protocols for cell therapy product generation and characterization.
- Participate in the establishment and operation of an automated cGMP manufacturing facility for cell therapy products, ensuring compliance with all regulatory requirements.
- Establish and maintain relationships with key external partners, including contract manufacturing organizations (CMOs), suppliers, and regulatory agencies.
- Contribute to the preparation and submission of regulatory documents, including INDs, BLAs, and other necessary filings.
- Train team members on process development practices.
You might thrive in this role if you:
- Have a minimum of 5 years of experience leading process development in the cell therapy space.
- Are psyched by the startup environment, and an ethos of pushing the envelope.
- Have experience with bioreactors and closed automated systems.
- Possess knowledge of pluripotent cell-derived therapeutics, production technologies, and cell engineering platforms.
- Have prior experience with translating an R&D process to a well-defined and characterized bioprocess for manufacturing.
- Possess deep knowledge of CMC, cGMP regulations, FDA, ICH, and other relevant regulatory requirements.
- Demonstrated experience with IND submissions and approvals are highly desired.
- Experience setting up standards for QA/QC ensuring consistency across therapeutic products.
- Have developed, scaled up, and/or scaled out bioprocesses for cell therapy products and their tech transfer to manufacturing.
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.
