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Redwood City, California, United States
Onsite
Retro develops therapies for diseases driven by the biology of aging. We focus on cellular reprogramming and autophagy to broadly improve tissue function by targeting mechanisms of aging 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.
You are a rigorous, curious, small-molecule analytical development professional who seeks to understand the underlying science and regulatory framework, not just execute against it. You stay current by engaging directly with guidelines, literature, and data, and pair scientific depth with practical judgment. You are confident yet humble in evolving areas and enjoy sharing knowledge and exchanging ideas openly. You are comfortable in a lean environment, balancing hands-on work with oversight of external partners. You communicate clearly across internal and external partners, and are excited to thoughtfully incorporate new tools, including AI, into analytical and CMC workflows.
Drive and own analytical control strategy development for Retro’s small molecule autophagy program – test methods, specifications, stability, and impurity control for drug substance and drug product – as it advances from Phase I toward Phase II.
Develop analytical methods internally, with hands-on UPLC and LC-MS work, including characterization of process impurities and degradation products.
Transfer methods to external partners.
Oversee outsourced analytical and QC activities, including method development, validation, release testing, stability monitoring, OOS/OOT investigations, and data package review.
Support identity testing for critical raw materials, including method selection, vendor coordination, data review, and targeted in-house analytical work.
Support formulation development by using analytical data to evaluate solubility, dissolution, stability, and provide analytical support to discovery and preclinical programs.
Partner with the CMC lead and quality team, and manage external CDMOs and CROs.
Support bioanalytical development work for future generations of the compound.
Have a MS or PhD in analytical chemistry, medicinal chemistry, pharmaceutical sciences, or a related field, with 7+ years relevant industry experience in small-molecule analytical development, including experience in a regulated GxP environment.
Understand phase-appropriate analytical control strategy, including specifications, stability strategy, impurity control, reference standards, method validation, and regulatory documentation.
Have experience developing, validating, transferring, and overseeing analytical methods for drug substance and drug product release, stability, dissolution, and impurity testing.
Have experience working with CDMOs, CROs, or external laboratories to manage analytical development, validation, release testing, stability testing, investigations, and data review.
Bring hands-on expertise with UPLC/HPLC and LC-MS method development, troubleshooting, and data interpretation for small molecule assay, purity, impurities, degradation products, and related substances.
Can operate independently in a lean environment, prioritize across internal hands-on work and external partner oversight, and communicate analytical recommendations clearly to cross-functional partners.
Have run LC-MS/MS for drugs and metabolites in complex biological matrices.
Have experience contributing to or reviewing analytical sections of CTD Module 3 submissions; direct authoring experience is preferred.
Have worked on extractables and leachables, container closure, or device compatibility studies.
Have supported discovery or preclinical programs with analytical data to accelerate progression decisions.
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.