Immunome, Inc.

Immunome, Inc.

Contract: Manager, CMC Stability Management and Analysis

Bothell, Washington, United States · Contract

Sponsorship not specifiedDetected 21 days ago
GMPFDA RegulatoryLeadership

About the role

  • 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.

Responsibilities

  • Create and maintain stability plans, master schedules, pull calendars, and study trackers across multiple development programs.
  • 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.
  • Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies.
  • 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.

Requirements

  • 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.
  • Hands-on experience with stability data review, trending, shelf -life assessment.
  • Working knowledge of GMP requirements, data integrity expectations, ICH stability guidance, and regulatory expectations for biologics stability studies.
  • Knowledge and Skills
  • Prior experience managing external CTLs, CDMOs, CROs, or stability storage vendors supporting regulated studies.
  • In-depth understanding of biologics <span data-ccp

Nice to have

  • Demonstrated experience managing GMP stability programs for biologics, monoclonal antibodies, fusion proteins, or other large molecules
  • ADC experience preferred.
  • Contract or consultant experience in a matrixed biotech environment preferred.

Skills

  • Knowledge and Skills - In-depth understanding of biologics <span data-ccp

Company info

  • We are advancing an innovative portfolio of therapeutics, supported by a leadership team with deep experience in the design, development, and commercialization of cutting-edge therapies, including antibody-drug conjugates.
  • We are also advancing a broad portfolio of early-stage ADCs pursuing undisclosed solid tumor targets.
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