Contract: 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 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.
• 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.

WA State Contract Pay Transparency (Hourly Rate)

$88.10 - $100.05 USD

E/E/O

Immunome, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

E-Verify

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