Position OverviewThe Senior Manager / Associate Director, External Manufacturing Operations is responsible for meeting Immunome's supply requirements by enabling and overseeing operations performed at Contract Development and Manufacturing Organizations (CDMOs). This role focuses on biologics manufacturing but will support additional modalities as needed.
Responsibilities - Serve as the Supplier Relationship Manager (SRM) for specified CDMOs and primary liaison between the CDMO and Immunome.
- Collaborate closely with Legal to support the development and negotiation of service agreements, supply contracts, and statements of work across development and commercial phases.
- Lead one or more Virtual Management Teams (VMTs) comprising Quality, Product Supply, Technical Development, and other cross-functional stakeholders as necessary. Ensure Immunome's project deliverables stay on track. Align priorities and key communications with the CDMO.
- Conduct well-organized and documented project team meetings with CDMOs. Ensure CDMO progress is tracking to plan (e.g., campaign preparation, manufacturing operations, release activities, logistics, etc.). Proactively address delays to avoid impact on supply or regulatory milestones.
- Develop a thorough understanding of Immunome's drug product manufacturing processes. Support technical reviews of master and executed batch records, specifications, investigations, and change requests, as required.
- Monitor CDMO performance through Key Performance Indicators (KPIs) and drive improvements aligned with Immunome's expectations. Lead or participate in periodic Business Review Meetings.
- Work closely with department management and finance team to provide timely progress updates. Ensure that unexpected cost variances are communicated quickly.
- Maintain comprehensive knowledge of the CDMO's systems, capabilities, capacities, requirements, and business practices.
- Monitor spending against budget. Ensure CDMO invoicing is accurate and aligned with contractual terms.
Other Responsibilities and Projects- Assist with technology transfers as needed, change implementation, and regulatory submission reviews.
- Support Technical Operations sourcing efforts and the qualification of new CDMOs.
- Support risk assessment development, and implementation of manufacturing network strategies.
- This is an individual contributor role. Depending on the business needs and organizational considerations, this role may include staff supervisory responsibly as the product portfolio and manufacturing network expand.
Qualifications - Bachelor's or advanced degree in biotechnology, biology, chemistry, chemical engineering, or related field.
- Minimum of 10 years of biopharmaceutical industry experience, and direct responsibility overseeing third parties performing cGMP manufacturing.
- Ability to travel (domestic and international) up to 25%, with occasional evening and/or weekend commitment.
Knowledge and Skills - Strong organizational, communication, and collaboration skills.
- Strong technical background in biotechnology/pharmaceutical manufacturing or process development.
- Hands-on expertise in drug product process development or cGMP drug product manufacturing. Experience with highly potent products is desired.
- Prior success in overseeing external manufacturing operations is required, either as an SRM or Subject Matter Expert (SME). Experience with both clinical and commercial manufacturing is desired.
- Well-versed in Quality systems and experienced with deviation investigations, change controls, and corrective actions.
- Possess strong negotiation skills and be versed in general contractual terms.
- Comfortable with ambiguity and uncertainty; adapt swiftly with focus on delivering to the business needs as priorities change.
Washington State Pay Range
$152,504-$185,763 USD
