Associate Director, Quality Control, Biologics

About the role

Immunome is seeking a highly experienced and strategic Associate Director, Quality Control, Biologics to lead QC strategy and execution in support of our biologics and ADC portfolio. This role will be responsible for oversight of GMP QC activities, including analytical method transfer, qualification and validation, release and stability testing, investigation support, external testing lab management, and QC documentation supporting clinical development and regulatory submissions.

Responsibilities

• Develop and implement phase-appropriate QC strategies for biologics and ADC programs across drug substance and drug product development, release, and stability.
• Provide scientific, technical, and GMP oversight for QC testing, method lifecycle activities, specifications, reference standards and critical reagent strategies.
• Contribute to the long-term vision for Immunome’s QC capabilities, including evaluation of technologies, systems, and external partnerships to support portfolio growth.
• Oversee execution of GMP and non-GMP analytical testing for intermediates, drug substance, drug product, and stability samples in collaboration with CTLs and CDMOs.
• Lead review and interpretation of QC data, trends, OOS/OOT results, deviations, investigations, CAPAs, change controls, and technical reports.
• Serve as the QC representative on cross-functional program teams, ensuring QC deliverables are aligned with CMC timelines.
• Manage external contract testing laboratories and CDMO QC functions to ensure timely, compliant, and high-quality study execution.
• Author and review QC-related SOPs, protocols, validation and qualification plans, method transfer reports, specifications, CoAs, stability summaries, and regulatory submission content.
• Support preparation of IND, BLA, CTD, and other global regulatory submissions, including responses to health authority questions related to QC and analytical controls.
• Lead, mentor, and develop scientists and technical staff, fostering a high-performance culture grounded in quality, accountability, and collaboration.

Qualifications

• A Bachelor’s or advanced degree in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, Biology, or a related field.
• 10+ years of experience in Quality Control, Analytical Development, CMC, or related functions within the biotechnology or biopharmaceutical industry or equivalent; advanced degree may offset some experience.
• Demonstrated experience supporting QC programs for biologics; ADC experience strongly preferred.
• Proven experience with GMP release and stability testing, analytical method transfer, qualification, validation, and lifecycle management.
• Prior experience managing CTLs, CDMOs, CROs, or other external partners supporting regulated testing.

Skills

• In-depth understanding of GMP standards, data integrity expectations, and global regulatory guidance relevant to biologics QC, analytical validation, stability, and CMC submissions.
• Strong technical knowledge of biologics and ADC product quality attributes, including potency, purity/impurities, charge variants, glycosylation, aggregation, conjugation-related attributes, and linker-payload characteristics.
• Working knowledge of analytical technologies such as HPLC/UPLC, CE-SDS/cIEF, icIEF, LC-MS, ELISA, binding and potency assays, compendial methods, and microbiological testing.
• Operational and strategic experience with phase-appropriate method development, qualification, validation, method transfer, compendial verification, and stability program design.
• Ability to assess QC data trends, deviations, OOS/OOT results, and analytical risks, translating findings into practical recommendations and CAPA plans.
• Excellent judgment and the ability to transition seamlessly between hands-on technical review and strategic decision-making.
• Comfortable with ambiguity and complex challenges; adapt quickly and lead teams through dynamic environments.
• Exceptional communication skills with the ability to collaborate effectively across functions and with external partners.
• Solution-oriented problem-solving skills, with the capacity to manage multiple projects and prioritize in a fast-paced setting.

Pay

The pay range for this position is $177,813 - $203,985 USD.