Manager, CMC Stability Management and Analysis

Responsibilities

• Review stability protocols for long-term and accelerated studies
• Create and maintain stability plans, master schedules, pull calendars, and study trackers
• Oversee execution of stability studies and ensure timely sample pulls, testing, and data delivery
• Review stability data for completeness, accuracy, data integrity, and trend behavior
• Support evaluation of OOS/OOT results and atypical trends
• Prepare stability summaries, trend reports, shelf-life assessments, and technical risk assessments

Requirements

• Bachelor’s or advanced degree in Chemistry, Biochemistry, Pharmaceutical Sciences, Biology, Chemical Engineering, or related field
• 8+ years of experience in stability, QC, Analytical Development, CMC, or technical operations in biotech/biopharma
• Demonstrated experience managing GMP stability programs for biologics or large molecules
• Experience managing external CTLs, CDMOs, CROs, or stability storage vendors
• Working knowledge of GMP requirements, ICH stability guidance, and regulatory expectations

Preferred Qualifications

• ADC (Antibody-Drug Conjugate) experience
• Experience with analytical technologies such as HPLC/UPLC, SEC, CE-SDS, cIEF, and ELISA
• Contract or consultant experience in a matrixed biotech environment

About the Company

Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies, including antibody-drug conjugates.