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.
Position Overview
The Director, Supply Operations will lead and develop Immunome’s Supply Operations function. This role is accountable for ensuring efficient, compliant, and uninterrupted supply of clinical and commercial packaged products. This is a highly visible role that will help shape Product Supply infrastructure, external partner networks, operational and business processes critical to Immunome’s growing pipeline and commercial success.
Responsibilities
- Develop and oversee a high-performing team of supply operations professionals. Maintain a positive and inclusive environment where staff are motivated, empowered, and challenged.
- Accountable for the successful planning and execution of clinical and commercial labeling and packaging operations.
- Own business relationship with relevant external suppliers. Develop and implement metrics and KPIs to measure performance. Ensure supplier performance is routinely reviewed via formal business review meetings and periodic executive steering committee meetings.
- Actively engage with Planning, Commercial, Clinical Development, and Regulatory to understand evolving commercial supply and clinical study plans.
- Monitor drug inventory levels across distribution depots and trial sites, working closely with the Planning team to ensure supply plans are appropriately adjusted as needed.
- Advise cross-functional teams on optimal supply strategy, associated timelines, and risks. Ensure plans are communicated and integrated into program timelines.
- Design, develop, and implement business processes and cGMP procedures encompassing but not limited to labeling and packaging operations, comparator and co-medication sourcing, returns and reconciliation.
- Support department leadership and Finance team to develop budgets and performance targets, ensure spending is accurately tracked and variances are communicated proactively.
- Support the development and implementation of supply management tools for use in day-to-day operations. Support the design and implementation of systems including ERP, Serialization, IRT, etc.
- With a continuous-improvement mindset, seek opportunities to evolve processes and systems to increase compliance and efficiency.
- Partner with Quality to ensure efficient documentation reviews pre- and post-production and support QP release requirements where required.
- Manage Quality systems work, including training, change controls, investigations, corrective and preventive actions.
Qualifications
- Bachelor’s or advanced degree in Supply Chain Management, Biotechnology, or related field.
- APICS or ISM certification is preferred.
- Minimum of 12 years of biopharmaceutical industry experience in supply chain roles, supporting both clinical and commercial product supply.
- Minimum of 8 years of supervisory experience.
- Position will require domestic and international travel (up to 20%) and occasional evening and/or weekend commitment.
Knowledge and Skills
- Excellent cross-functional collaboration, communication, and influencing skills.
- Strong business acumen, including budgeting, forecasting, and contract negotiation.
- Demonstrated ability to lead through ambiguity and scale operations in a dynamic environment.
- Experience with both sterile injectables and oral dosage forms is desired.
- Strong understanding of clinical and commercial supply and distribution models and frameworks.
- Demonstrated experience supporting commercial product launches.
- Thorough understanding of regulations applying to supply chain activities, including cGMP, GCP, GDP, and computer systems/Part11 compliance.
- Thorough understanding of clinical and commercial labeling and packaging requirements, planning, and execution.
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: E-Verify Participation Poster | Right to Work Poster (English) | Right to Work Poster (Spanish).