SVP CMC

RBW Consulting; United States; On-site; USD 300,000 - 600,000; Full time

Job summary

RBW Consulting seeks a Senior Vice President, CMC, to lead Manufacturing Science and Technology (MSAT) and Analytical Sciences in a remote role with EST or CST preferred. The executive will drive strategic and operational oversight across manufacturing support, validation, technology transfer, analytical development, lifecycle management, regulatory support, and external partnerships.

Candidates should have 20+ years in biotech/pharma, with executive CMC/MSAT leadership and strong regulatory

Qualifications

• Executive leadership experience in CMC, MSAT, Technical Operations, and/or Analytical Sciences.
• Strong experience in regulatory submissions and health authority interactions.
• Extensive experience managing CMOs/CDMOs and supporting commercial products.
• PhD preferred in a relevant scientific discipline.

Responsibilities

• Lead MSAT and Analytical Sciences organizations.
• Oversee technology transfer, process validation, and lifecycle management.
• Support commercial manufacturing, process optimization, validation, and CAPA investigations.
• Lead regulatory submissions and health authority interactions.
• Manage external manufacturing and testing partners.
• Partner cross-functionally with Quality, Regulatory Affairs, Supply Chain, Manufacturing, and Technical Operations leadership.

Skills

Executive leadership

CMC strategy

Cross-functional collaboration

Regulatory interactions

Education

PhD preferred in a relevant scientific discipline

Job description

Senior Vice President, CMC (Remote | EST or CST Preferred)

Commercial-stage biotech seeking a senior CMC executive to lead Manufacturing Science & Technology (MSAT) and Analytical Sciences. This individual will provide strategic and operational leadership across commercial manufacturing support, process validation, technology transfer, analytical development, lifecycle management, regulatory support, and external manufacturing partnerships.

Key Responsibilities

• Lead MSAT and Analytical Sciences organizations.


• Support commercial manufacturing, process optimization, validation, and lifecycle management activities.


• Oversee technology transfers, manufacturing investigations, CAPAs, and process improvements.


• Provide leadership for analytical development, method validation, and commercial assay support.


• Lead CMC support for regulatory submissions and health authority interactions.


• Manage external manufacturing and testing partners.


• Partner cross-functionally with Quality, Regulatory Affairs, Supply Chain, Manufacturing, and Technical Operations leadership.

Qualifications

• 20+ years of biotechnology/pharmaceutical industry experience.


• Executive leadership experience in CMC, MSAT, Technical Operations, and/or Analytical Sciences.


• Strong commercial biologics manufacturing experience.


• Proven success with regulatory submissions, inspections, and health authority interactions.


• Extensive experience managing CMOs/CDMOs and supporting commercial products.


• PhD preferred in a relevant scientific discipline.