Analytical & Product Quality Lead, Small Molecule na Retro
Retro · Redwood City, Estados Unidos Da América · On-site
- Escritório em Redwood City
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 are building a mission-driven, collaborative team operating with speed, transparency, and adaptability.
We are hiring a new member of the team who will lead analytical development and product quality strategy for RTR242, a small molecule in Phase I for the treatment of neurodegenerative diseases such as Alzheimer’s. In this role, you will provide hands-on leadership for analytical development while owning the end-to-end product quality strategy across CMC, manufacturing, and QC. You will work with our CDMO and CRO partners to achieve quality standards appropriate to stage and intended use.
About You:
In This Role, You Will:
Lead Quality Assurance for RTR242, providing end-to-end oversight of manufacturing and QC activities at CDMOs, including tech transfer, performance monitoring, deviation oversight, issue resolution, and continuous improvement and data integrity.
Define and maintain a scientifically sound, risk-based, phase-appropriate control strategy across materials, manufacturing processes, analytical methods, and specifications to ensure product identity, strength, quality, purity, and stability in alignment with cGMP expectations.
As part of the control strategy, define, justify, and maintain drug substance and drug product specifications, including critical quality attributes, acceptance criteria, scientific rationale, and lifecycle management.
Lead the analytical method strategy across the product lifecycle, including QC release and stability methods supporting clinical development.
Oversee analytical method development, qualification, and validation at CDMOs and CROs in alignment with ICH guidance and phase-appropriate regulatory expectations.
Establish and oversee stability strategies, including protocol design, stability-indicating methods, data trending and interpretation, and shelf-life proposals.
Serve as the product quality subject-matter expert for investigations, deviations, and CAPAs, ensuring robust root cause analysis and effective resolution.
Identify and mitigate analytical, quality, and control strategy gaps and risks to support CMC readiness, compliant product release, and regulatory submissions.
Serve as the primary analytical and product quality interface with CDMOs and CROs, establishing clear responsibilities, robust quality agreements, and governance to support effective oversight and sustained inspection readiness.
Partner cross-functionally with Research, CMC, Regulatory Affairs, and QMS stakeholders to ensure analytical and quality strategies are scientifically sound, compliant, and clearly and defensibly documented.
Contribute to global regulatory submissions and support health authority interactions in collaboration with Regulatory Affairs.
You Will Excel In This Role If You:
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Bring 7+ years of experience in small-molecule analytical development, quality control, and/or product quality within a regulated pharmaceutical environment.
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Have hands-on experience with analytical method development, validation, and transfer, including techniques such as HPLC, GC, dissolution, impurity methods, and related assays.
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Have a strong working knowledge of ICH guidelines, GMP requirements, and regulatory expectations for clinical-stage small-molecule products.
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Have experience supporting IND-enabling or early clinical CMC activities.
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Have experience overseeing CDMO and/or CRO analytical activities, including method transfer, performance management, and external partner oversight.
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Demonstrate strong judgment in identifying and addressing CMC, quality, and regulatory risks before they affect timelines or development progress.
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Understand how analytical and quality expectations evolve across early clinical development and apply appropriate, phase-aligned rigor.
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Communicate clearly and effectively across technical teams, senior leadership, and external stakeholders.
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Have an advanced degree in Chemistry, Pharmaceutical Sciences, or a related scientific discipline, or equivalent experience.
It's A Bonus If You:
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Have prior experience serving as a product quality or analytical lead within a matrixed organization.
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Have prior experience leading or providing technical oversight for impurity identification, metabolite or degradation pathway characterization, and root cause investigations, leveraging LC/MS and related techniques.
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Have experience supporting or leading formulation development activities.
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Have exposure to regulatory interactions or authoring CMC sections related to analytical control strategies.
Additional Information
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 based on 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.
