Director / Senior Director, External Manufacturing Operations

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** The Director / Senior Director, External Manufacturing Operations provides strategic leadership and oversight of Immunome’s external manufacturing network to ensure supply requirements and business objectives are met. The Director leads and develops a team of external manufacturing professionals, establishes and maintains effective supplier governance, and partners closely with Technical Operations leadership and cross-functional stakeholders to drive operational performance and successful execution of clinical and commercial programs. This role also plays a key part in developing and executing external manufacturing and supply strategies, strengthening supplier relationships, and evolving Immunome’s external manufacturing capabilities as the company’s portfolio and manufacturing network continue to grow. **Responsibilities** - Provide overall leadership for Immunome’s External Manufacturing Operations function, with responsibility for the performance, development, and effectiveness of the team overseeing CDMOs and other external service providers. - Lead, coach, and develop a team of external manufacturing professionals. Establish clear priorities, expectations, and accountabilities; support staff development and the continued growth of organizational capabilities as the portfolio and manufacturing network expand. - Ensure Virtual Management Teams (VMTs) are empowered and operate effectively, collaboratively, and consistently across programs. Provide leadership in resolving significant risks, delays, and competing priorities that could affect supply or key program milestones. - Establish and maintain effective governance across the external manufacturing network. Ensure business reviews, steering committees, and executive-level meetings are conducted at appropriate frequencies and with the right level of engagement. Serve as a senior escalation point for significant operational, contractual, supply, and relationship matters. - Develop strong cross-functional relationships internally, partnering closely with Technical Operations leadership, Legal, Finance, Regulatory, and other key stakeholders to align activities and ensure business objectives are met. - Provide senior leadership with clear and timely updates regarding manufacturing performance, supply risks, network capacity, financial considerations, and other matters requiring management attention or decision-making. - Contribute to the development and execution of Immunome’s external manufacturing and supply network strategy, and business continuity planning. - Support regulatory submission activities and regulatory inspections, as required. - Contribute to the continuous improvement of Technical Operations processes, governance frameworks, and ways of working to support the continued growth of Immunome’s product portfolio and external manufacturing network. **Qualifications** - Bachelor’s degree in biotechnology, biology, chemistry, chemical engineering, pharmaceutical sciences, or a related field; advanced degree preferred. - Minimum of 15 years of progressive experience in the biotechnology or pharmaceutical industry, including significant responsibility for cGMP manufacturing operations and oversight of external manufacturing partners. - Demonstrated experience leading external manufacturing activities supporting clinical and commercial products. - Proven ability to build and manage strategic relationships with CDMOs, including engagement with senior business leaders, site heads, and executive management. - experience contributing to manufacturing network strategy, supply planning, technology transfer, commercial readiness, and risk management. - Position requires domestic and international travel of up to approximately 25%, with occasional evening and/or weekend commitments based on manufacturing activities and business needs. **Knowledge and Skills** - Strong leadership and people-management skills, with a demonstrated ability to coach, develop, and retain high-performing professionals. - Demonstrated success managing complex external manufacturing organizations and supplier relationships across development and commercial stages. - Strong strategic thinking and business judgment, with the ability to balance technical, operational, financial, quality, regulatory, and supply considerations. Demonstrated ability to identify and manage manufacturing and supply risks, resolve complex issues, and drive cross-functional decision-making. - Broad technical understanding of biotechnology/pharmaceutical manufacturing and process development. Hands-on experience in process development and/or cGMP manufacturing is strongly preferred. Experience with highly potent products is desirable. - Strong understanding of cGMP requirements and pharmaceutical Quality Systems, including deviations, investigations, change controls, CAPAs, and batch disposition activities. - Strong executive communication, influencing, and negotiation skills, with the ability to effectively engage internal and external senior leadership. Expert knowledge of supply agreements, service agreements, statements of work, and other commercial terms relevant to external manufacturing. - Ability to operate effectively in a fast-paced and evolving environment, manage ambiguity, and adjust priorities while maintaining focus on critical business objectives.