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$178k–$204k/yr
Full-time
bachelor degree, postgraduate degree
Posted 39d ago
~40 hrs/week
Responsibilities
Lead the QC strategy and execution for biologics and ADC portfolios, overseeing GMP activities and external laboratory management. Responsible for ensuring product quality through method validation, stability testing, and supporting regulatory submissions.
Requirements
Requires a Bachelor's or advanced degree in a scientific field with over 10 years of experience in QC or CMC within the biopharmaceutical industry. Must have demonstrated expertise in biologics, GMP release testing, and managing external partners like CDMOs.
Full job description
Company Overview
Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. 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. Our pipeline includes varegacestat, an investigational gamma secretase inhibitor for which an NDA has been accepted by the U.S. FDA; IM-1021, a clinical-stage ROR1 ADC; IM-1617, a clinical-stage solid tumor ADC; and IM-3050, a clinical-stage FAP-targeted radioligand therapy. We are also advancing a broad portfolio of early-stage ADCs pursuing undisclosed solid tumor targets.
Position Overview
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.
The successful candidate will bring deep technical expertise in biologics and ADC analytical testing, a strong working knowledge of GMP requirements and global regulatory expectations, and the leadership skills necessary to manage cross-functional and external partners. This position offers a highly visible opportunity to build scalable QC processes and ensure Immunome’s products are tested with scientific rigor, operational discipline, and patient-centered quality.
Responsibilities
QC Strategy and Governance
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.
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.
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 leadteams 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.
Washington State Pay Range
$177,813—$203,985 USD
E/E/O
Immunome, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted therapies designed to improve outcomes for cancer patients. We are advancing an innovative portfolio of therapeutics, drawing on leadership that previously played key roles in the design, development, and commercialization of cutting-edge targeted cancer therapies, including antibody-drug conjugate therapies (ADCs). Our most advanced pipeline programs are varegacestat (formerly AL102), a gamma secretase inhibitor which is currently in a Phase 3 trial for treatment of desmoid tumors; IM-1021, a ROR1-targeted ADC which is currently in a Phase 1 trial; and IM-3050, a FAP-targeted radioligand, which recently received IND clearance. Our pipeline also includes IM-1617, IM-1335, and IM-1340, all of which are preclinical ADCs pursuing undisclosed targets with expression in multiple solid tumors.
Offices: 18702 North Creek Pkwy, 100, Bothell, Washington 98011, US
Based on 2136 listings with disclosed salaries, most healthcare jobs in Washington pay between $80k–$188k per year. Individual offers vary with seniority, company size, and specialization.
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