Senior Manager, Analytical Development and QC, Small Molecule

Position Overview

Immunome is seeking a highly experienced and collaborative Senior Manager, Analytical Development and QC, Small Molecule to lead analytical method development, validation, and quality control activities supporting our small molecule programs from early development through regulatory submissions and commercialization.

The successful candidate will bring deep technical expertise in small molecule analytical chemistry, understanding of cGMP and ICH expectations, and proven experience operating in an outsourced development model with CDMOs and contract testing laboratories. Reporting to the Director, Analytical Development & QC, this individual will shape Immunome’s small molecule analytical development and QC strategy and advance our oncology pipeline.

Responsibilities

Strategic Leadership

• Develop and execute phase-appropriate analytical development and QC strategies for ADC linker payload components, small molecule intermediates, and drug substance, including specifications and control strategies.
• Provide technical leadership for analytical method development, qualification, validation, and lifecycle management.
• Establish and maintain analytical development plans, stability strategies, and comparability/bridging approaches to support process changes, scale-up, and technology transfers.

Program Oversight and Execution

• Manage execution of analytical testing to support in-process controls, release, stability, and characterization.
• Partner with cross-functional leaders across CMC, Process Chemistry, Manufacturing, QA, and Regulatory to ensure seamless integration of analytical deliverables within development timelines.
• Critically review and interpret analytical data to troubleshoot methods, manufacturing issues, investigate OOS/OOT results, and drive root-cause analysis and CAPA activities.
• Support review of batch records from an analytical perspective.

Vendor and Partner Management

• Manage and provide technical oversight of CDMOs, and contract testing labs to ensure high-quality, timely, and compliant method development, validation, and routine QC testing.
• Lead scope definition, issue resolution, deviations, change controls, and inspection readiness activities.

Regulatory and Documentation Support

• Author and review analytical sections of CMC documents and regulatory submissions (e.g., IND/CTA, NDA/MAA, CTD), including method descriptions, validation summaries, specifications, and stability data.
• Support responses to analytical and quality-related questions from global health authorities and internal stakeholders.
• Ensure all analytical activities comply with cGMP and relevant regulatory/compendial guidance (e.g., ICH Q2, Q3, Q6A, Q7; USP/EP/JP).

Leadership and Collaboration

• Communicate complex analytical concepts, results, and recommendations clearly and effectively to diverse audiences.
• Contribute to building Immunome’s internal analytical capabilities and best practices, including evaluation of new technologies and analytical approaches where appropriate.

Qualifications

• A minimum of a Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, Chemistry, or a related field with 5+ years of industry experience; or an M.S. with 10+ years; or a B.S. with 12+ years. Experience must be in small molecule analytical development and QC within the biopharmaceutical industry.
• Demonstrated experience developing, validating, and transferring analytical methods, small molecule intermediates and drug substance in cGMP environment.
• Hands-on expertise with chromatography and related techniques (HPLC/UPLC, GC, LC-MS, Karl Fischer, spectroscopy) and impurity profiling.
• Experience managing external partners (CDMOs/contract testing laboratories) and stability programs.
• Prior oncology drug development experience preferred.
• ADC linker payload experience preferred.
• Up to 25% travel.

Knowledge and Skills

• Highly skilled in method development using chromatographic and supporting techniques (LC, GC, IC)
• Solid understanding of phase-appropriate control strategies for small molecules (specifications, impurities, stability, and comparability).
• Working knowledge of cGMP expectations and analytical-related ICH/compendial guidance (e.g., ICH Q2, Q3, Q6A, Q7; USP/EP/JP).
• Excellent communication skills — capable of clearly conveying complex data, technical concepts, and recommendations to diverse audiences.
• Exceptional organizational, analytical, and problem-solving skills.
• Ability to work effectively in a fast-paced, dynamic biotech environment and balance multiple priorities.