Associate Director, Quality Control, Biologics

Program Oversight and Execution 

• 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. 

External Laboratory and Partner Management 

• Manage external contract testing laboratories and CDMO QC functions to ensure timely, compliant, and high-quality study execution. 

• Oversee method transfer, qualification, validation, verification, and troubleshooting activities across external laboratories. 

• Establish expectations for documentation quality, sample management, stability pulls, and communication cadence with external partners. 

Regulatory and Documentation Support 

• 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. 

• Stay informed of emerging regulatory expectations and compendial requirements, integrating relevant guidance into Immunome’s QC strategy. 

Leadership and Collaboration 

• Lead, mentor, and develop scientists and technical staff, fostering a high-performance culture grounded in quality, accountability, and collaboration. 

• Partner closely with Analytical Development, Process Development, Manufacturing, Quality Assurance, Regulatory CMC, Supply Chain, and Program Management to align QC plans with broader development objectives. 

• Communicate complex QC data, risks, and recommendations clearly to functional leaders and program teams, enabling timely, science-based decision-making. 

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. 

• Experience managing matrixed projects, or external partner relationships in a fast-paced development environment. 

Knowledge and 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.