External Manufacturing Operations Manager - Small Molecule

Immunomeinc; Bothell (WA); On-site; USD 109,000 - 138,000; Full time

Job summary

Immunome, Inc. is seeking a Manager of External Manufacturing Operations to oversee day-to-day activities with CDMOs and third-party partners. The role focuses on small molecule programs initially, with potential expansion to additional modalities.

You will coordinate cross-functional teams across Quality, Product Supply, Regulatory, and Technical Development to ensure timely manufacturing operations, manage risks, and support continuous improvement across the external manufacturing network.

Qualifications

• Bachelor's degree in biotechnology, biology, chemistry, chemical engineering, pharmaceutical sciences or related field.
• A minimum of 7 years of relevant experience in biotech/pharma.
• Hands-on experience in small molecule manufacturing operations or related activities.
• Experience working with CDMOs and cross-functional collaboration.
• Up to ~25% travel, domestic and international; occasional evenings/weekends.

Responsibilities

• Provide day-to-day oversight of assigned suppliers and coordinate with external partners.
• Lead or participate in Virtual Management Teams with cross-functional stakeholders.
• Coordinate meetings, monitor progress against plans, and manage risks.
• Understand manufacturing processes and participate in reviews of batch records and QA docs.
• Monitor supplier KPIs and drive continuous improvement with internal and external partners.
• Escalate significant risks to leadership and align with governance forums.
• Collaborate on contracts, statements of work, and budgeting with leadership.
• Communicate manufacturing progress and risks to cross-functional stakeholders.
• Support technology transfers, supplier sourcing, and risk assessments.

Skills

Organizational skills

Communication

Collaboration

cGMP knowledge

Quality Systems

Problem solving

Contract terms familiarity

Education

Bachelor's degree in biotechnology/biology/chemistry/chemical engineering/pharmaceutical sciences

Advanced degree preferred

Job description

Immunome, Inc. is seeking a Manager of External Manufacturing Operations to oversee day-to-day activities with CDMOs and third-party partners. The role focuses on small molecule programs initially, with potential expansion to additional modalities.

You will coordinate cross-functional teams across Quality, Product Supply, Regulatory, and Technical Development to ensure timely manufacturing operations, manage risks, and support continuous improvement across the external manufacturing network.