Senior CMO Manager, External Manufacturing

Bavarian Nordic•Durham, CA

2d•$150,000 - $195,000•Remote

About The Position

The Senior CMO Manager, External Manufacturing owns the end-to-end management of contract manufacturing organization (CMO) activities, ensuring reliable, compliant, and timely delivery in collaboration with internal stakeholders and external partners. The role serves as the key interface between Bavarian Nordic and its CMOs, driving alignment, transparency, and performance across manufacturing operations. The position oversees production activities by monitoring performance, tracking KPIs, and maintaining operational control. It reviews and approves critical CMO documentation, including deviations, change controls, and manufacturing instructions, in accordance with Bavarian Nordic's Quality Management System (QMS), while ensuring timely escalation and resolution of issues. The role also manages Work Orders and related financial processes, including invoice handling. The manager contributes to reporting and planning processes such as QMRs, APQRs, and long-range planning, and acts as person-in-plant when required to support collaboration and on-site oversight. The position is remote, with East Coast candidates preferred, and reports to the CMO Director, US.

Requirements

At least 7 years of experience in pharmaceutical or biotech manufacturing, including CMO oversight.
Strong expertise in deviation management, change control, and Quality Management Systems (QMS).
Solid understanding of regulatory requirements for drug substance and/or drug product manufacturing.
Broad cross-functional knowledge across QA, QC, Supply Chain, MSAT, and Regulatory Affairs.
Proven stakeholder management skills and the ability to operate effectively in a global, cross-functional environment.

Responsibilities

Manage CMO performance and delivery, including oversight of production activities, KPI tracking, and operational control.
Serve as the key interface between Bavarian Nordic and CMOs and manage stakeholder relationships.
Align communication and governance structures between Bavarian Nordic and CMOs.
Support governance, communication, and ways of working across internal teams and external manufacturing partners.
Ensure implementation of Bavarian Nordic changes at CMOs.
Support and facilitate material and information flow to CMOs.
Review and approve critical CMO documentation, including deviations, change controls, and manufacturing instructions, in alignment with BN QMS.
Ensure timely escalation and resolution of issues.
Manage Work Orders and associated financial processes, including invoice handling.
Contribute to QMRs, APQRs, and long-range planning.
Act as person-in-plant when required to provide collaboration and on-site oversight.
Review long-range planning protocols, allocation plans, and contract amendments.