Senior CMO Manager, External Manufacturing

Bavarian Nordic

Durham (NC)

À distance

USD 150 000 - 195 000

Plein temps

Il y a 2 jours
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Résumé du poste

Bavarian Nordic in remote US (East Coast preferred) is seeking a Senior CMO Manager for External Manufacturing to own end-to-end CMO activities, ensuring compliant, timely production and serving as the primary interface with external partners.

You will monitor production performance, review deviations and change controls, manage work orders and invoicing, and contribute to planning processes such as QMRs and APQRs, with on-site oversight as needed.

Qualifications

  • 7+ years’ experience in pharmaceutical or biotech manufacturing, including CMO oversight.
  • Strong expertise in deviation management, change control, and Quality Management Systems (QMS).
  • Regulatory knowledge for drug substance/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.

Responsabilités

  • Oversee CMO performance and delivery to ensure compliant, timely manufacturing.
  • Manage stakeholder communications and act as primary CMO interface.
  • Governance, document control, and change management in BN QMS.
  • Monitor KPIs, oversee budget, and coordinate financial activities with CMOs.
  • Ensure BN changes are implemented at CMOs and align with contracts.
  • Support material and information flow to CMOs and manage deviations.
  • Review LRP protocols, allocation plans, and contract amendments.

Connaissances

CMO oversight
QMS
Deviation management
Change control
Regulatory knowledge
Cross-functional collaboration

Description du poste

## Senior CMO Manager, External ManufacturingApply: Remote: Durham: Full time: Posted Today: JR101620**Protecting our tomorrow**Job Title: **Senior CMO Manager, External Manufacturing**Location: **Remote – East Coast Preferred**Department: **External Manufacturing**Reports To: **CMO Director, US**Salary Range: **$150k - $195k** **About Bavarian Nordic** Bavarian Nordic is a global vaccine company focused on helping to protect lives through innovative vaccines, public health partnership, and expanded access to disease prevention. We work across emerging infectious diseases, travel health, and public health preparedness to help communities, healthcare providers, pharmacies, and health systems improve vaccine awareness, access, and delivery. With a growing commercial portfolio and strong global partnerships, Bavarian Nordic is evolving how vaccines are supported across healthcare ecosystems — combining scientific innovation with customer engagement, education, and public health impact. **Position Overview** In this role, you will take ownership of the end-to-end management of CMO activities, ensuring reliable, compliant, and timely delivery in close collaboration with both internal stakeholders and external partners. Acting as the key interface between Bavarian Nordic and its CMOs, you will drive alignment, transparency, and performance across all manufacturing operations. A key part of the role is maintaining oversight of production activities, including monitoring performance, tracking KPIs, and ensuring operational control.You will review and approve critical CMO documentation such as deviations, change controls, and manufacturing instructions in accordance with BN QMS, while ensuring timely escalation and resolution of issues. In addition, you will manage Work Orders and associated financial processes, including invoice handling. The role also involves contributing to key reporting and planning processes such as QMRs, APQRs, and long-range planning, as well as acting as person-in-plant when required to ensure strong collaboration and on-site oversight. **Key Responsibilities** * CMO performance oversight and delivery* Stakeholder management 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 BN 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* Review LRP protocols, allocation plans, and contract amendments **Qualifications** * 7+ years’ 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 with the ability to operate effectively in a global, cross-functional environment**Why Join Us** Join a mission-driven global vaccine company at a pivotal stage of growth and evolution. At Bavarian Nordic, you’ll have the opportunity to help shape innovative commercial programs, support public health initiatives, and contribute to how vaccines are accessed across healthcare channels. We foster a collaborative, entrepreneurial culture where cross-functional partnership, creativity, and impact are valued alongside scientific excellence. Bavarian Nordic is an Equal Opportunity Employer. All qualified applications will receive consideration for employment and will not be discriminated against based on race, color, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status. For more information, visit *www.bavarian-nordic.com* *#LI-MA1*
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