Remote CMO Manufacturing Leader - External Operations

Bavarian Nordic; Durham (NC); Remote; USD 150,000 - 195,000; Full time

Job summary

Bavarian Nordic is seeking a Senior CMO Manager, External Manufacturing, to own end-to-end CMO activities, ensuring reliable, compliant, and timely delivery through close collaboration with internal stakeholders and external partners.

You will review critical CMO documentation, manage work orders and invoices, and contribute to reporting and planning processes such as QMRs and APQRs, while providing on-site oversight as required to maintain manufacturing excellence.

Qualifications

• 7+ years' experience in pharmaceutical or biotech manufacturing.
• Experience with deviation management and change control.
• 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 in a global, cross-functional environment.

Responsibilities

• Oversee CMO performance and delivery.
• Manage stakeholders and CMO interface.
• Governance, communication, and ways of working.
• Quality oversight, documentation, and compliance (QMS).
• Operational control, KPIs, and financial coordination.
• Align communication and governance structures between Bavarian Nordic and CMOs.
• Ensure implementation of BN changes at CMOs.
• Support and facilitate material and information flow to CMOs.
• Handle deviations and change controls in alignment with BN QMS.

Skills

CMO oversight

Stakeholder management

Regulatory/compliance knowledge

Deviations & Change Control

QMS familiarity

Job description

Bavarian Nordic is seeking a Senior CMO Manager, External Manufacturing, to own end-to-end CMO activities, ensuring reliable, compliant, and timely delivery through close collaboration with internal stakeholders and external partners.

You will review critical CMO documentation, manage work orders and invoices, and contribute to reporting and planning processes such as QMRs and APQRs, while providing on-site oversight as required to maintain manufacturing excellence.