Analytical & Product Quality Lead, Small Molecule

📋 Description

• Lead QA for RTR242 with end-to-end oversight at CDMOs/CROs, incl. tech transfer.
• Define risk-based control strategy across materials, processes, analytics, and specs per cGMP.
• Define and maintain drug substance/product specs, CQAs, and acceptance criteria.
• Collaborate with QMS leads to standardize quality requirements.
• Lead analytical method strategy across lifecycle, incl. QC release and stability methods.
• Oversee method development, qualification, and validation at CDMOs/CROs per ICH.

🎯 Requirements

• 7+ years in small-molecule analytical development, QC & product quality in regulated pharma.
• Hands-on analytical method development, validation, and transfer (HPLC, GC, dissolution).
• Strong knowledge of ICH guidelines, GMP, and regulatory expectations for clinical-stage products.
• Experience supporting IND-enabling or early clinical CMC activities.
• Experience overseeing CDMO/CRO analytical activities, method transfer, and external partner oversight.
• Strong ability to identify and mitigate CMC/quality/regulatory risks.

🎁 Benefits

• Medical, dental, and vision insurance for you and your family.
• 401(k) plan with 4% matching.
• Flexible time off and 10 company holidays per year.
• Paid parental leave.
• Annual learning & development stipend.
• Monthly longevity stipend.