Head of Quality and Analytical Development, Cell Therapy

Lever, Inc.; Redwood City (CA); On-site; USD 230,000 - 280,000; Full time

Benefits offered by this job

Equity

Health benefits

401(k) matching

Flexible time off

Parental leave

Learning stipend

Longevity stipend

Lunch & snacks

Job summary

Retro is hiring to lead our Quality and Analytical Development team in Redwood City, CA. You will guide QA/QMS, analytical development, and CMC activities for cell-therapy programs and broader pipelines, reporting to the CEO.

You will partner with R&D, Process Development, Manufacturing, Regulatory, and Clinical to shape CQAs, control strategies, and critical parameters, while driving a robust QMS across cGMP operations.

Qualifications

• 8+ years of QA/QMS, QC, Analytical Development, or CMC experience.
• Experience taking cell-therapy programs through GMP manufacturing and clinical development.
• Experience building a phase-appropriate GMP Quality System.
• Hands-on expertise in one or more cell-therapy analytical areas (flow cytometry, potency and functional assays, molecular methods).
• Knowledge of cGMP, FDA cell-therapy guidance, ICH, 21 CFR Part 11, data integrity, and analytical validation.

Responsibilities

• Lead the Quality & Analytical Development team, setting priorities, coaching and developing the team, and building the group as needs evolve.
• Be accountable for the phase-appropriate QMS and independent Quality oversight supporting internal cGMP cell-therapy manufacturing.
• Partner with Program teams across R&D, Process Development, and Manufacturing, as well as Regulatory and Clinical, to define CQAs, control strategies, specifications, and critical process parameters.
• Guide analytical strategy and the full method lifecycle across our cell-therapy programs, from product characterization and method development through qualification and validation, transfer, QC implementation, and ongoing performance monitoring.
• Provide technical leadership across cell-therapy methods including flow cytometry, potency and functional assays, qPCR/ddPCR, ELISA, identity, purity/impurity, and viability testing.
• Oversee Quality review of GMP records, deviations, CAPAs, change controls, qualification/validation activities, batch documentation, and product disposition/release.
• Guide analytical investigations, troubleshooting, robustness, system suitability, critical reagent, and instrument-control strategies.
• Support regulatory strategy and submissions across analytical, CMC, Quality, potency, comparability, and control-strategy topics.
• Provide or coordinate Quality and analytical oversight for Retro’s small-molecule and gene-therapy programs as needed.
• Decide which capabilities should be built internally versus supported by consultants, CROs, CDMOs, or other external specialists.

Skills

8+ years exp

Cell-therapy

QA/QMS

QC

Analytical Development

CMC knowledge

Flow cytometry

Regulatory knowledge

Tools

qPCR/ddPCR

ELISA

Job description

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 lead our Quality and Analytical Development team and to continue to shape the quality culture at Retro.

About the role:

In this position, you will work hands-on with the team and bring the experience and perspective of having previously taken cell-therapy programs through GMP manufacturing and into the clinic.

Your primary focus will be our iPSC-derived cell therapy programs. You will continue building the Quality Unit supporting our internal cGMP manufacturing, bring practical regulatory and industry perspective to the team, and guide Analytical Development and QC work. You will also help provide Quality and analytical oversight across our broader pipeline, including small-molecule and gene-therapy programs.

You will report to the CEO.

About you:

You’re a first-principles thinker who believes in building the simplest, most effective team and systems for each phase of development. You’ve seen Quality done in different ways and can separate true best practices from unnecessary processes, bringing the right pieces together for Retro while embracing our tenet of Speed × Accuracy.

You know when to flex, when to hold the line, and how to keep patient safety at the center of those decisions. You’re comfortable moving between technical details, Quality decisions, and broader program strategy, while staying directly involved with the work.

You’re optimistic about our ability to positively impact the human condition and extend healthy human lifespan.

In this role you will:

• Lead Retro’s Quality & Analytical Development team, setting priorities, coaching and developing the team, and building the group as needs evolve.


• Be accountable for the phase-appropriate QMS and independent Quality oversight supporting internal cGMP cell-therapy manufacturing.


• Partner with Program teams across R&D, Process Development, and Manufacturing, as well as Regulatory and Clinical, to define CQAs, control strategies, specifications, and critical process parameters.


• Guide analytical strategy and the full method lifecycle across our cell-therapy programs, from product characterization and method development through qualification and validation, transfer, QC implementation, and ongoing performance monitoring.


• Provide technical leadership across cell-therapy methods including flow cytometry, potency and functional cell-based assays, qPCR/ddPCR, ELISA, identity, purity/impurity, and viability testing.


• Oversee Quality review of GMP records, deviations, CAPAs, change controls, qualification/validation activities, batch documentation, and product disposition/release.


• Guide analytical investigations, troubleshooting, robustness, system suitability, critical reagent, and instrument-control strategies.


• Support regulatory strategy and submissions across analytical, CMC, Quality, potency, comparability, and control-strategy topics.


• Provide or coordinate Quality and analytical oversight for Retro’s small-molecule and gene-therapy programs as needed.


• Decide which capabilities should be built internally versus supported by consultants, CROs, CDMOs, or other external specialists.

You might thrive in this role if you:

• Have 8+ years of relevant experience, with deep cell-therapy experience and substantial responsibility across QA/QMS, QC, Analytical Development, and/or CMC.


• Have taken cell-therapy programs through GMP manufacturing and clinical development.


• Have meaningful experience building and operating a phase-appropriate GMP Quality system.


• Have personally taken cell-therapy analytical methods through the full lifecycle, from development and characterization through qualification and validation, transfer, and routine GMP QC use, including release and stability testing.


• Bring deep hands-on expertise in one or more cell-therapy analytical areas, such as flow cytometry, potency and functional assays, or molecular methods, and enough breadth to coach the team and make sound technical decisions across the broader analytical program.


• Have experience with batch review, disposition, or release decisions in a GMP environment.


• Have strong working knowledge of cGMP, relevant FDA cell-therapy and CMC guidance, ICH guidelines, 21 CFR Part 11, data integrity, and analytical validation.


• Are comfortable operating broadly in a startup environment or lean organization and can work effectively without a separate specialist for every function.

It’s a bonus if you:

• Have direct experience with iPSC-derived cell therapies.


• Have experience supporting cell-therapy programs through late-stage or pivotal clinical development.


• Experience working across multiple therapeutic modalities, including direct small-molecule and/or gene-therapy Quality, QC, AD, or CMC experience.

$230,000 - $280,000 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 and medical leave


• - Annual learning & development stipend


• - Monthly Longevity stipend


• - Daily Retro-sponsored lunch and snacks

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.