Manager, External Manufacturing Operations
Immunome, Inc.
September 02, 2026
Remote friendly (Bothell, WA)
United States
Operations
Position Overview
The Manager, External Manufacturing Operations, ensures Immunome’s supply requirements are met by coordinating and overseeing external suppliers, including CDMOs and other third-party service providers. Serves as a key point of contact for assigned partners and collaborates cross-functionally to support clinical and commercial programs. Initially focuses on small molecule programs, with potential to support additional modalities as the portfolio expands.
Responsibilities
- Provide day-to-day oversight of assigned suppliers; coordinate activities between Immunome and external partners.
- Participate in and lead Virtual Management Teams (VMTs) with cross-functional stakeholders; align priorities, deliverables, and communications with CDMOs.
- Coordinate and conduct internal/external meetings; monitor progress for pre-campaign preparation, manufacturing operations, release, and logistics; identify and help resolve delays/risks.
- Support technical reviews of batch records, specifications, investigations, change controls, and other manufacturing documentation.
- Monitor supplier performance via KPIs; support improvements through business review/governance forums.
- Maintain knowledge of supplier systems/capabilities/capacity; escalate significant operational, supply, quality, or relationship risks as appropriate.
- Support development/negotiation of service agreements and statements of work.
- Monitor spending vs. budget; review CDMO invoicing for accuracy; communicate cost variances.
- Provide updates on manufacturing progress, risks, priorities, and decision needs.
- Support technology transfers, supplier sourcing, and qualification.
- Support manufacturing/supply risk assessments and risk mitigation implementation.
- Contribute to process/tool continuous improvement for external manufacturing network management.
- Support manufacturing data collection, trending, and CPV summaries/report drafts.
Qualifications
- Bachelor’s degree in biotechnology, biology, chemistry, chemical engineering, pharmaceutical sciences, or related field (advanced degree preferred).
- Minimum 7 years relevant biotech/pharma industry experience (or equivalent combination).
- Hands-on small molecule manufacturing operations/process development/process engineering experience.
- Experience working directly with CDMOs in a matrixed, cross-functional environment.
- Domestic/international travel up to ~25%; occasional evening/weekend commitments.
Knowledge & Skills
- Strong organizational, communication, and collaboration skills.
- Working knowledge of cGMP and pharmaceutical Quality Systems (deviations, investigations, change controls, CAPAs, batch disposition).
- Strong problem-solving; ability to identify manufacturing/supply risks and drive resolution.
- Working knowledge of external manufacturing service agreements/SOWs.
- Ability to operate in a fast-paced, evolving environment and manage multiple priorities.
The Manager, External Manufacturing Operations, ensures Immunome’s supply requirements are met by coordinating and overseeing external suppliers, including CDMOs and other third-party service providers. Serves as a key point of contact for assigned partners and collaborates cross-functionally to support clinical and commercial programs. Initially focuses on small molecule programs, with potential to support additional modalities as the portfolio expands.
Responsibilities
- Provide day-to-day oversight of assigned suppliers; coordinate activities between Immunome and external partners.
- Participate in and lead Virtual Management Teams (VMTs) with cross-functional stakeholders; align priorities, deliverables, and communications with CDMOs.
- Coordinate and conduct internal/external meetings; monitor progress for pre-campaign preparation, manufacturing operations, release, and logistics; identify and help resolve delays/risks.
- Support technical reviews of batch records, specifications, investigations, change controls, and other manufacturing documentation.
- Monitor supplier performance via KPIs; support improvements through business review/governance forums.
- Maintain knowledge of supplier systems/capabilities/capacity; escalate significant operational, supply, quality, or relationship risks as appropriate.
- Support development/negotiation of service agreements and statements of work.
- Monitor spending vs. budget; review CDMO invoicing for accuracy; communicate cost variances.
- Provide updates on manufacturing progress, risks, priorities, and decision needs.
- Support technology transfers, supplier sourcing, and qualification.
- Support manufacturing/supply risk assessments and risk mitigation implementation.
- Contribute to process/tool continuous improvement for external manufacturing network management.
- Support manufacturing data collection, trending, and CPV summaries/report drafts.
Qualifications
- Bachelor’s degree in biotechnology, biology, chemistry, chemical engineering, pharmaceutical sciences, or related field (advanced degree preferred).
- Minimum 7 years relevant biotech/pharma industry experience (or equivalent combination).
- Hands-on small molecule manufacturing operations/process development/process engineering experience.
- Experience working directly with CDMOs in a matrixed, cross-functional environment.
- Domestic/international travel up to ~25%; occasional evening/weekend commitments.
Knowledge & Skills
- Strong organizational, communication, and collaboration skills.
- Working knowledge of cGMP and pharmaceutical Quality Systems (deviations, investigations, change controls, CAPAs, batch disposition).
- Strong problem-solving; ability to identify manufacturing/supply risks and drive resolution.
- Working knowledge of external manufacturing service agreements/SOWs.
- Ability to operate in a fast-paced, evolving environment and manage multiple priorities.