Director / Senior Director, External Manufacturing Operations
Immunome, Inc.
September 02, 2026
Remote friendly (Bothell, WA)
United States
Operations
Responsibilities:
- Provide strategic leadership for External Manufacturing Operations, overseeing team performance for CDMOs and external service providers.
- Lead, coach, and develop external manufacturing professionals; set priorities, expectations, and accountabilities.
- Ensure Virtual Management Teams (VMTs) operate effectively across programs; resolve major risks, delays, and competing priorities affecting supply or milestones.
- Establish governance across the external manufacturing network (business reviews, steering committees, executive meetings); act as senior escalation for operational/contractual/supply/relationship issues.
- Partner cross-functionally with Technical Operations, Legal, Finance, Regulatory, and others to meet business objectives.
- Provide timely updates on manufacturing performance, supply risks, network capacity, and financial considerations.
- Contribute to external manufacturing/supply strategy and business continuity planning.
- Support regulatory submissions and inspections as required.
- Improve Technical Operations processes, governance frameworks, and ways of working.
Qualifications:
- Bachelor’s degree in biotech/biology/chemistry/chemical engineering/pharmaceutical sciences or related field; advanced degree preferred.
- 15+ years progressive biotech/pharma experience, including cGMP manufacturing and oversight of external manufacturing partners.
- Experience leading external manufacturing for clinical and commercial products.
- Proven relationship management with CDMOs (senior leaders, site heads, executive management).
- Experience contributing to manufacturing network strategy, supply planning, technology transfer, commercial readiness, and risk management.
- Travel up to ~25%.
Knowledge & Skills:
- Strong people leadership; manage complex external manufacturing and supplier relationships.
- Strategic judgment balancing technical/operational/financial/quality/regulatory/supply; risk identification/mitigation.
- cGMP/QMS knowledge (deviations, investigations, change controls, CAPAs, batch disposition); process development/cGMP hands-on strongly preferred.
- Strong executive communication, influencing, negotiation; deep understanding of supply/service agreements/SOWs.
- Ability to operate in fast-paced, evolving environments.
Washington State Pay Range:
$200,087 - $295,000 USD
- Provide strategic leadership for External Manufacturing Operations, overseeing team performance for CDMOs and external service providers.
- Lead, coach, and develop external manufacturing professionals; set priorities, expectations, and accountabilities.
- Ensure Virtual Management Teams (VMTs) operate effectively across programs; resolve major risks, delays, and competing priorities affecting supply or milestones.
- Establish governance across the external manufacturing network (business reviews, steering committees, executive meetings); act as senior escalation for operational/contractual/supply/relationship issues.
- Partner cross-functionally with Technical Operations, Legal, Finance, Regulatory, and others to meet business objectives.
- Provide timely updates on manufacturing performance, supply risks, network capacity, and financial considerations.
- Contribute to external manufacturing/supply strategy and business continuity planning.
- Support regulatory submissions and inspections as required.
- Improve Technical Operations processes, governance frameworks, and ways of working.
Qualifications:
- Bachelor’s degree in biotech/biology/chemistry/chemical engineering/pharmaceutical sciences or related field; advanced degree preferred.
- 15+ years progressive biotech/pharma experience, including cGMP manufacturing and oversight of external manufacturing partners.
- Experience leading external manufacturing for clinical and commercial products.
- Proven relationship management with CDMOs (senior leaders, site heads, executive management).
- Experience contributing to manufacturing network strategy, supply planning, technology transfer, commercial readiness, and risk management.
- Travel up to ~25%.
Knowledge & Skills:
- Strong people leadership; manage complex external manufacturing and supplier relationships.
- Strategic judgment balancing technical/operational/financial/quality/regulatory/supply; risk identification/mitigation.
- cGMP/QMS knowledge (deviations, investigations, change controls, CAPAs, batch disposition); process development/cGMP hands-on strongly preferred.
- Strong executive communication, influencing, negotiation; deep understanding of supply/service agreements/SOWs.
- Ability to operate in fast-paced, evolving environments.
Washington State Pay Range:
$200,087 - $295,000 USD