Position OverviewThe Manager, External Manufacturing Operations, is responsible for ensuring Immunome's supply requirements are met through the coordination and oversight of activities performed by external suppliers, including Contract Development and Manufacturing Organizations (CDMOs) and other third-party service providers. The Manager will serve as a key point of contact for assigned external partners and collaborate cross-functionally to ensure the effective execution of activities in support of clinical and commercial programs.
The role will initially focus on small molecule programs, with the opportunity to support additional modalities as Immunome's portfolio and external manufacturing network evolve and expand.
Responsibilities- Provide day-to-day oversight of assigned suppliers, serving as a primary point of contact and facilitating effective coordination between Immunome and its external partners.
- Participate in and, as appropriate, lead Virtual Management Teams (VMTs) comprising Quality, Product Supply, Technical Development, Regulatory, and other cross-functional stakeholders. Support alignment of priorities, deliverables, and key communications with CDMOs.
- Coordinate and conduct well-organized and documented meetings internally and with assigned external suppliers. Monitor progress against established plans, including pre-campaign preparation, manufacturing operations, release activities, and logistics. Identify potential delays and risks and work with internal and external stakeholders to support timely resolution.
- Develop a thorough understanding of Immunome's manufacturing processes. Participate in technical reviews of master and executed batch records, specifications, investigations, change controls, and other manufacturing documentation, as required.
- Monitor supplier performance through established Key Performance Indicators (KPIs) and work with internal stakeholders and external partners to identify and implement opportunities for improvement. Participate in periodic Business Review Meetings and other supplier governance forums.
- Maintain understanding of assigned suppliers' systems, capabilities, capacities, requirements, and business practices. Escalate significant operational, supply, quality, or relationship risks to leadership, as appropriate.
- Collaborate with Legal and External Manufacturing leadership in the development and negotiation of service agreements, statements of work, and other contractual arrangements.
- Partner with External Manufacturing leadership, Finance, and Project Management to monitor spending against budget, review CDMO invoicing for accuracy and alignment with contractual terms and communicate significant cost variances in a timely manner.
- Provide clear and timely updates to External Manufacturing leadership and cross-functional stakeholders regarding manufacturing progress, risks, priorities, and issues requiring attention or decision-making.
- Support technology transfers, supplier sourcing and qualification activities, as required.
- Participate in the development and periodic review of manufacturing and supply risk assessments and support implementation of appropriate risk mitigation plans.
- Contribute to the development and continuous improvement of processes, tools, and ways of working that support effective management of Immunome's external manufacturing network.
- Support manufacturing data collection, trending, and analysis, including the preparation of continuous process verification (CPV) summaries and report drafts, as required.
Qualifications- Bachelor's degree in biotechnology, biology, chemistry, chemical engineering, pharmaceutical sciences, or a related field required; an advanced degree is preferred.
- A minimum of 7 years of relevant experience in the biotechnology or pharmaceutical industry, or an equivalent combination of work and education experience.
- Hands-on experience in small molecule manufacturing operations, process development, process engineering, or related activities.
- Experience working directly with CDMOs and successfully collaborating in a matrixed, cross-functional environment.
- 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 organizational, communication, and collaboration skills, with the ability to effectively coordinate activities across internal functions and external partners.
- Working knowledge of cGMP requirements and pharmaceutical Quality Systems, including deviations, investigations, change controls, CAPAs, and batch disposition activities.
- Strong problem-solving skills, with the ability to identify manufacturing and supply risks, coordinate cross-functional input, and drive issues toward resolution.
- Working knowledge of service agreements, statements of work, and other contractual terms relevant to external manufacturing.
- Ability to operate effectively in a fast-paced and evolving environment, manage multiple priorities, and adapt as business needs change.
Washington State Pay Range
$108,969-$138,046 USD
