Description

<div class="content-intro">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, drawing on leadership that previously played key roles in the design, development, and commercialization of cutting-edge therapies, including antibody-drug conjugate therapies. Our pipeline includes varegacestat, a late-clinical stage GSI; IM-1021, a clinical-stage ROR1 ADC; and IM-3050, a FAP-targeted radiotherapy that recently received IND clearance. We are also advancing a broad portfolio of early stage ADCs pursuing undisclosed solid tumor targets.</div>Position Overview The Associate Director of Quality Operations is responsible for providing strategic and operational QA leadership across assigned programs related to clinical and commercial manufacturing operations, with a focus on antibody-drug conjugates (ADCs). This role ensures compliance with global regulatory standards, leads internal and external audits, and drives continuous improvement initiatives. The Director collaborates cross-functionally and with external partners to ensure product quality throughout the development lifecycle and provides strategic quality leadership aligned with company objectives. Experience with biologics and ADCs is required; familiarity with small molecule operations is a plus. Responsibilities Quality Operations: <ul> <li>Oversee quality aspects of starting material, intermediates, drug substance and drug product manufacturing as well as packaging/labeling activities</li> <li>Review and approve specifications affecting product quality and oversee the development of master batch records, process and method validation/protocol reports and other technical documents created to support all stages of the product lifecycle, from development to commercialization.</li> <li>Disposition early phase through commercial batches.</li> <li>Ensure effective CAPA management, change controls, deviations, and other GMP-related processes are followed during manufacturing and testing of products.</li> <li>Interact with manufacturing, clinical, or other functional areas that impact quality operations and provide support as needed.</li> <li>Perform risk assessments and implement appropriate quality and process controls to ensure proper oversight of production activities.</li> <li>Support vendor qualification program and monitor vendor performance.</li> <li>Prompt communication to management of potential compliance issues.</li> <li>Participate in internal and external project team meetings.</li> </ul> &nbsp;Documentation and Record Control: <ul> <li>Perform periodic reviews and revisions of SOPs, policies, and Quality Agreements to align with regulatory updates and business needs.</li> <li>Establish, review and/or approve Quality Agreements and ensure they are properly stored and managed.</li> <li>Manage other internal and external documentation related to QA operations</li> </ul> &nbsp;Regulatory Compliance and Inspection Readiness: <ul> <li>Ensure external parties are inspection-ready, in compliance with regulatory requirements, and prepared for GMP audits or inspections from FDA or other international regulatory bodies.</li> <li>Collaborate with regulatory affairs and cross-functional teams to support regulatory submissions, including providing necessary documentation and ensuring compliance with filing requirements.</li> <li>Support site preparation for regulatory inspections including personnel preparation and training</li> <li>Participate in Quality Management Review meetings, as needed.</li> <li>Assist in updating CMC sections of regulatory and quality documents</li> </ul> &nbsp;Operational Leadership and Continuous Improvement: <ul> <li>Drive continuous improvement initiatives across quality operations to enhance operational efficiency, reduce risk, and improve product quality.</li> <li>Provide strategic direction and hands-on leadership for operations teams, ensuring alignment with business goals and regulatory demands.</li> <li>Develop and implement metrics to monitor and report on the performance of Operations, identifying areas for improvement and ensuring corrective actions are implemented.</li> <li>Promote a strong Quality culture within the organization. Identify compliance risks and be a part of the solution through ownership and collaboration.</li> </ul> Qualifications <ul> <li>Bachelor’s degree in life sciences, chemistry, engineering, or related field; advanced degree (MS, PhD, MBA) preferred.</li> <li>A minimum of 9 years of experience in pharmaceutical, biotechnology, or life sciences industries industry quality assurance. Quality operations and ADC experience is a requirement.&nbsp;</li> <li>Proven experience in managing GMP operations, QMS, including vendor management and CMO oversight.</li> <li>Strong knowledge of FDA, EMA, ICH, and other global regulatory guidelines and their application to Quality Operations.</li> <li>Experience supporting clinical and commercial stage programs, with a strong understanding of the product lifecycle from development through to commercialization.</li> <li>Position may require domestic and international travel (up to 20%).</li> </ul> Knowledge and Skills <ul> <li>Strong project management, organizational, and leadership skills with the ability to multitask and prioritize in a fast-paced environment.</li> <li>Excellent verbal and written communication skills, with the ability to collaborate effectively across functions and at all levels of the organization.</li> <li>Demonstrated ability to lead cross-functional teams and manage external vendors and stakeholders.</li> <li>Proficiency in using electronic QMS platforms (e.g., MasterControl, TrackWise, Dot Compliance) and Microsoft Office (Word, Excel, PowerPoint).</li> <li>Strategic thinking with a proactive approach to problem-solving and process improvement.</li> <li>Strong experienced with antibody drug conjugates and biologics manufacturing processes. Some experience with small molecule manufacturing processes, a plus.</li> </ul><div class="content-pay-transparency"><div class="pay-input"><div class="title">Washington State Pay Range</div><div class="pay-range">$175,100&mdash;$202,446 USD</div></div></div><div class="content-conclusion">E/E/O Immunome, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. E-Verify Immunome, Inc. is a participant in E-Verify. Please review the following notices: <a href="https://immunome.box.com/s/bopxukipfidxjscs4bjxt75f90bvpppk" target="_blank">E-Verify Participation Poster</a> | <a href="https://immunome.box.com/s/r51g9subw1wqni9xkutbl6up635sjr8e" target="_blank">Right to Work Poster (English)</a> | <a href="https://immunome.box.com/s/r3ekbimwh988my9vzl76tnlbg60zvh9u" target="_blank">Right to Work Poster (Spanish)</a>.</div>