Contract - Manager, Clinical Supply Operations

Company Overview

Immunome is a clinical-stage targeted oncology company committed to developing first- 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 ADC with an active IND, and IM-3050, a FAP-targeted radioligand, which is the subject of an IND expected to be submitted in the first quarter of 2025. 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.

Position Overview

The Manager, Clinical Supply Operations, Contractor will play a key role in ensuring timely and compliant delivery of clinical supplies to investigational sites by enabling and overseeing key business processes and cGMP operations performed at Contract Manufacturing Organizations (CMOs). This role centers on overseeing the supply of finished drug products for radioligand therapy programs, and possibly other programs and modalities, as required.  

Responsibilities

• Participate in Clinical Operations study teams; maintain a close understanding of evolving clinical study plans and demand forecasts.
• Maintain a close understanding of drug product, finished drug product, and comparator inventories at all nodes.
• Assist the Planning team in developing production plans, establishing lot information and inventory tracking by study and country.
• Initiates clinical FDP carton and label design.
• Serve as the primary point-of-contact for specified CMOs providing clinical labeling, packaging, and distribution services.
• Conduct well-organized meetings with CMOs. Ensure CMO progress is tracking to plan (e.g., carton and label design, label text, batch operations and release activities, logistics, etc.). Proactively address delays to avoid impact on supply.
• Supports implementation and maintains the inventory and supply management functionality of the IRT/RTSM systems.
• Provides periodic clinical supply status to CMC and to the Clinical Operations Teams
• Support the development of Supply Operations business processes and standard operating procedures, as required.

 Qualifications

• Minimum of 5 years of clinical supply operations experience in a pharmaceutical or biotech field is essential.
• Excellent communication skills are essential.
• Close familiarity with cGMP and GCP regulatory requirements is essential.
• Demonstrated proficiency with IRT and RTSM systems is essential.

Knowledge and Skills

• Strong organizational, communication, and collaboration skills.
• Must be closely familiar with cGMP clinical labeling and packaging operations. Experience with highly potent products is a plus.
• Expertise working with an enterprise level planning system (ERP) is desired.
• Must be versed in Quality systems, and have experience with cGMP deviation investigations, change controls, and corrective actions.
• Must possess negotiation skills and be familiar with general contractual terms.
• Must be comfortable with ambiguity and uncertainty; must adapt swiftly with focus on delivering to the business needs as priorities develop/change.
• Position will require domestic and international travel (up to 25%) and occasional evening and/or weekend commitment.
• APICS certification a plus.

E/E/O

Immunome, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.