Principal Scientist Analytical Development & Quality Control, Small Molecule

We are seeking a new member of the Quality and Analytical team to support Retros clinical-stage autophagy program through Analytical Development (AD) and Quality Control (QC) as it advances from Phase I toward Phase II development.

As the primary AD/QC scientist for our small molecule program you will lead the analytical strategy for drug substance and drug product working closely with the Program Lead CMC Lead QA and external CDMOs and CROs. You will help ensure product quality support manufacturing and regulatory activities and strengthen the analytical foundation needed for continued clinical development.

Your responsibilities will include analytical method development qualification validation transfer specification setting stability studies impurity characterization and control formulation support regulatory documentation and oversight of outsourced analytical and QC activities. You will also perform targeted hands-on laboratory work to support development characterization troubleshooting and comparability assessments. Experience with LC-MS and other mass spectrometry-based techniques will be valuable.

This role reports to the Head of Quality & Analytical and partners closely with the CMC Lead to execute the analytical and quality strategy for Retros small molecule program.

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 analytical control strategy development for Retros small molecule autophagy program including drug substance and drug product methods specifications stability impurity control and regulatory support.

• Oversee outsourced QC and characterization methods including method development validation release testing stability testing analytical investigations and data package review.

• Support formulation development by using analytical data to help evaluate solubility dissolution stability manufacturability and overall product performance.

• Identify analytical formulation vendor or regulatory risks early and drive practical remediation plans in partnership with Q&AD CMC Quality Regulatory Research and external partners.

• Author and review analytical sections of regulatory submissions including Module 3 content related to analytical methods specifications validation stability and control strategy.

• Support identity testing strategy for critical raw materials including method selection vendor coordination data review and targeted in-house analytical work where appropriate.

• Provide UPLC-based analytical support for research activities where appropriate helping generate data that informs analogue characterization compound selection and progression decisions.

• Have 7 years of experience in small molecule analytical development or related pharmaceutical development work in a regulated 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 or 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 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.

• Hold an advanced degree in analytical chemistry chemistry pharmaceutical sciences medicinal chemistry or a related scientific discipline or bring equivalent industry experience.

• Have experience with small molecules that present solubility dissolution bioavailability manufacturability or product performance challenges.

• Have experience designing or overseeing forced degradation studies degradation pathway characterization and stability-indicating method development.

• Have experience with extractables and leachables assessments container closure compatibility administration-device compatibility or material compatibility studies.

• Have supported or authored analytical sections of CTD Module 3 regulatory submissions.

• Have experience applying analytical methods to research-stage small molecule analogue screening compound characterization or compound progression decisions.

• Have hands-on experience with LC-MS or other mass spectrometry-based approaches for compound characterization impurity identification degradation pathway assessment or analytical comparison of small molecule analogues.

• Have worked in a startup or resource-constrained environment where scientific independence adaptability and strong judgment were essential.