Position Overview

Immunome is seeking an experienced Contract: Manager, CMC Stability Management and Analysis to oversee execution of outsourced stability programs. This contract role will be responsible for maintaining stability pull schedules, data review, and vendor oversight activities across mAb intermediate, drug substance, and drug product. 

The successful consultant will bring practical expertise in GMP stability operations, biologics and large-molecule stability requirements, understanding of ADC stability indicating assays and outsourced laboratory management. This position requires a hands-on program manager who can translate technical and regulatory expectations into actionable plans, manage timelines and risks across external partners, and ensure stability deliverables are met. 

Responsibilities

Study Execution and Operational Oversight 

• Review stability protocols for long-term and accelerated studies. 

• Create and maintain stability plans, master schedules, pull calendars, and study trackers across multiple development programs. 

• Oversee execution of stability studies and ensure timely sample pulls, testing initiation, data delivery, and escalation of schedule or quality risks. 

Data Review, Trending, and Technical Assessment 

• Review stability data for completeness, accuracy, data integrity, trend behavior, specification compliance, and consistency with expected product quality attributes. 

• Support evaluation of OOS/OOT results and atypical trends. 

• Prepare stability summaries, trend reports, shelf-life assessments, retest/expiry recommendations, and technical risk assessments to support program decision-making. 

Qualifications

• Bachelor’s or advanced degree in Chemistry, Biochemistry, Pharmaceutical Sciences, Biology, Chemical Engineering, or a related field. 

• 8+ years of experience in stability, QC, Analytical Development, CMC, or technical operations within the biotechnology or biopharmaceutical industry, or equivalent. 

• Demonstrated experience managing GMP stability programs for biologics, monoclonal antibodies, fusion proteins, or other large molecules; ADC experience preferred. 

• Hands-on experience with stability data review, trending, shelf-life assessment. 

• Prior experience managing external CTLs, CDMOs, CROs, or stability storage vendors supporting regulated studies. 

• Working knowledge of GMP requirements, data integrity expectations, ICH stability guidance, and regulatory expectations for biologics stability studies. 

• Contract or consultant experience in a matrixed biotech environment preferred. 

Knowledge and Skills

• In-depth understanding of biologics stability program management, including drug substance and drug product stability, retest/expiry dating, storage condition justification, and ongoing stability commitments. 

• Working knowledge of ICH Q1A(R2), Q1B, Q1D, Q1E, Q5C, relevant FDA/EMA expectations, and phase-appropriate application of stability requirements. 

• Strong understanding of biologics product quality attributes. 

• Familiarity with analytical technologies used in biologics stability testing, including HPLC/UPLC, SEC, CE-SDS/cIEF/icIEF, ELISA, binding and potency assays. 

• Strong project management skills with the ability to manage detailed schedules, multiple vendors, cross-functional dependencies, and competing program priorities. 

• Ability to interpret stability trends, identify risks, escalate issues appropriately, and drive practical solutions in collaboration with technical and quality stakeholders. 

• Excellent documentation, communication, and stakeholder management skills. 

• Comfort with ambiguity and dynamic timelines; ability to operate independently and drive execution with limited supervision.