Analytical Sciences, Small Molecule
Job Location:
Redwood City, CA - USA
Yearly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
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.
Were 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 Retros 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.
- Author and review analytical sections of Module 3 submissions covering methods specifications validation stability and control strategy.
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.
At Retro we do not use internal job titles. New hires join as a Member of X Team. For external calibration this role may map to different market-equivalent levels depending on experience independence and scope.
Total compensation includes competitive base salary generous equity and benefits including medical dental and vision insurance; 401(k) with 4% matching; flexible time off; paid parental leave; an annual learning & development stipend; monthly longevity stipend; and 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 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.
About Company
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 rac ... View more
