Principal Scientist Analytical Development & Quality Control, Small Molecule
On-siteRedwood City, California, United States
Job Summary
Lead analytical control strategy development for Retro's small molecule autophagy program, driving method development, qualification, validation, and transfer for drug substance and product. Oversee outsourced QC activities including release testing, stability studies, and analytical investigations while performing hands-on laboratory work for troubleshooting and comparability assessments. Support formulation development by evaluating solubility, dissolution, and manufacturability, and author regulatory documentation for CTD Module 3 submissions. Identify risks in analytical, formulation, or vendor areas to drive remediation plans with cross-functional partners.
Required Qualifications
- 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
Desired Qualifications
- 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
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