Sr. Scientist, Analytical Development and QC, Biologics

Immunome, Inc. • Bothell, WA

9h

About The Position

Immunome is seeking an experienced Senior Scientist, Analytical Development & QC to support its Antibody Drug Conjugate (ADC) portfolio. This role will be responsible for leading physicochemical analytical method development in collaboration with Contract Development and Testing Laboratories (CDMOs and CTLs), while also supporting the buildout of internal CMC analytical capabilities.
The successful candidate will bring strong hands-on expertise in ADC analytical method development and product characterization, with particular depth in Liquid Chromatography (LC), Capillary Electrophoresis (CE, including icIEF), and Mass Spectrometry–based techniques. Experience managing external analytical testing activities, supporting technology transfer, and contributing to regulatory submissions is highly valued.

Requirements

• Bachelor’s, Master’s, or PhD in Analytical Chemistry, Biochemistry, or a related scientific discipline.
• A minimum of 5 years of industry experience supporting CMC analytical method development with direct ADC experience.
• Demonstrated experience in analytical method development, qualification/validation, and QC support for biologics or ADCs.
• Experience managing external CDMO/CTL analytical activities, including oversight of timelines, data quality, and deliverables.
• Hands-on experience supporting analytical method transfer to external laboratories and/or GMP environments.
• Strong working knowledge of analytical separation principles for biologics and complex conjugated modalities.
• Proven experience in phase-appropriate analytical method development for ADC product characterization, release, and stability testing.
• Strong understanding of ADC product attributes, including conjugation chemistry, linker-payload properties, and DAR-related quality considerations.
• Hands-on expertise with advanced analytical platforms, including capillary electrophoresis, HPLC/UPLC, and mass spectrometry.
• Ability to interpret complex analytical data and translate results into actionable development insights.
• Strong communication skills and ability to collaborate effectively across cross-functional teams.
• Demonstrated ability to manage multiple priorities, troubleshoot complex technical challenges, and operate effectively in a dynamic, fast-paced environment.

Responsibilities

• Develop and execute physicochemical analytical methods for ADC characterization, release, and stability testing using LC, CE, icIEF, and MS technologies.
• Implement CMC analytical method development activities within Immunome laboratories in alignment with phase-appropriate requirements.
• Collaborate with Contract Testing Laboratories (CTLs) to develop, qualify, and validate robust analytical testing methodologies.
• Serve as Analytical Lead for assigned pipeline programs, providing scientific guidance on data interpretation and analytical strategy.
• Contribute to preparation of analytical sections of regulatory submissions and technical reports.
• Draft and review method protocols, development reports, and method transfer packages to support GMP activities.
• Maintain awareness of emerging analytical technologies and evolving regulatory expectations, integrating relevant innovations into Immunome’s analytical and QC strategy.
• Collaborate cross-functionally with Discovery, Process Chemistry, Formulation Development, and Quality teams to ensure analytical approaches align with broader program needs.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree
• Number of Employees: 101-250 employees