Senior Manager / Associate Director, External Manufacturing Operations
Immunome, Inc.
June 24, 2026
Remote friendly (Bothell, WA)
United States
Operations
Position Overview:
The Senior Manager / Associate Director, External Manufacturing Operations enables and oversees Contract Development and Manufacturing Organization (CDMO) operations to meet supply requirements (primarily biologics; other modalities as needed).
Responsibilities:
- Serve as Supplier Relationship Manager (SRM) for specified CDMOs and primary liaison between the CDMO and Immunome.
- Partner with Legal to develop and negotiate service agreements, supply contracts, and statements of work across development and commercial phases.
- Lead Virtual Management Teams (VMTs) with Quality, Product Supply, Technical Development, and other stakeholders; keep deliverables on track and align priorities/communications with the CDMO.
- Run documented CDMO project team meetings; ensure progress tracks to plan (campaign prep, manufacturing ops, release, logistics) and proactively address delays.
- Understand drug product manufacturing processes; support technical reviews of master/executed batch records, specifications, investigations, and change requests.
- Monitor CDMO performance via KPIs and drive improvements; lead or participate in Business Review Meetings.
- Provide timely progress updates to management and finance; ensure rapid communication of unexpected cost variances.
- Maintain knowledge of CDMO systems, capabilities, capacities, requirements, and business practices.
- Monitor spending vs. budget; ensure invoicing accuracy aligned with contractual terms.
Other Responsibilities:
- Assist with technology transfers, change implementation, and regulatory submission reviews.
- Support sourcing and qualification of new CDMOs.
- Support risk assessment and manufacturing network strategy.
- Individual contributor; may include staff supervisory responsibilities as the portfolio/network expands.
Qualifications:
- Bachelor’s or advanced degree in biotechnology, biology, chemistry, chemical engineering, or related field.
- Minimum 10 years biopharmaceutical industry experience overseeing third parties performing cGMP manufacturing (or equivalent).
- Travel up to 25% (domestic/international).
Knowledge & Skills:
- Strong organization, communication, and collaboration skills.
- Technical background in biopharmaceutical manufacturing/process development.
- Hands-on expertise in drug product process development or cGMP drug product manufacturing (highly potent experience desired).
- Prior external manufacturing oversight as an SRM or SME; clinical and commercial experience desired.
- Quality systems expertise (deviations, change control, corrective actions).
- Negotiation skills and comfort with contractual terms.
- Comfortable with ambiguity; adapt to changing priorities.
Application instructions:
None provided.
The Senior Manager / Associate Director, External Manufacturing Operations enables and oversees Contract Development and Manufacturing Organization (CDMO) operations to meet supply requirements (primarily biologics; other modalities as needed).
Responsibilities:
- Serve as Supplier Relationship Manager (SRM) for specified CDMOs and primary liaison between the CDMO and Immunome.
- Partner with Legal to develop and negotiate service agreements, supply contracts, and statements of work across development and commercial phases.
- Lead Virtual Management Teams (VMTs) with Quality, Product Supply, Technical Development, and other stakeholders; keep deliverables on track and align priorities/communications with the CDMO.
- Run documented CDMO project team meetings; ensure progress tracks to plan (campaign prep, manufacturing ops, release, logistics) and proactively address delays.
- Understand drug product manufacturing processes; support technical reviews of master/executed batch records, specifications, investigations, and change requests.
- Monitor CDMO performance via KPIs and drive improvements; lead or participate in Business Review Meetings.
- Provide timely progress updates to management and finance; ensure rapid communication of unexpected cost variances.
- Maintain knowledge of CDMO systems, capabilities, capacities, requirements, and business practices.
- Monitor spending vs. budget; ensure invoicing accuracy aligned with contractual terms.
Other Responsibilities:
- Assist with technology transfers, change implementation, and regulatory submission reviews.
- Support sourcing and qualification of new CDMOs.
- Support risk assessment and manufacturing network strategy.
- Individual contributor; may include staff supervisory responsibilities as the portfolio/network expands.
Qualifications:
- Bachelor’s or advanced degree in biotechnology, biology, chemistry, chemical engineering, or related field.
- Minimum 10 years biopharmaceutical industry experience overseeing third parties performing cGMP manufacturing (or equivalent).
- Travel up to 25% (domestic/international).
Knowledge & Skills:
- Strong organization, communication, and collaboration skills.
- Technical background in biopharmaceutical manufacturing/process development.
- Hands-on expertise in drug product process development or cGMP drug product manufacturing (highly potent experience desired).
- Prior external manufacturing oversight as an SRM or SME; clinical and commercial experience desired.
- Quality systems expertise (deviations, change control, corrective actions).
- Negotiation skills and comfort with contractual terms.
- Comfortable with ambiguity; adapt to changing priorities.
Application instructions:
None provided.