Senior Manager, External Manufacturing (Biotech)

TL;DR

Senior Manager, External Manufacturing (Biotech): Overseeing external manufacturing operations and CDMO site management with an accent on late-stage qualification and supply chain coordination. Focus on managing technical and business aspects of biologics production, ensuring regulatory compliance, and optimizing vendor performance.

Location: Must be based in South San Francisco or Newark, CA

Salary: $150,000–$170,000 per year

Company

A clinical-stage biotechnology company pioneering the development of allogeneic CAR T cell products for cancer and autoimmune diseases.

What you will do

• Oversee external manufacturing partners to ensure on-time supply meeting quality, compliance, and regulatory requirements.
• Lead cross-functional Joint Management Teams (JMTs) consisting of Quality, Supply Chain, and MSAT.
• Establish and manage manufacturing agreements, including MSAs and SOWs.
• Partner with Quality Assurance to manage the timely review and release of products and ensure CAPA implementation.
• Develop and monitor CDMO performance using KPIs and lead continuous improvement projects.
• Manage financial flows and site budgets in collaboration with Finance.

Requirements

• Bachelor’s degree in Science or Engineering.
• At least 8 years of directly related GMP pharmaceutical manufacturing experience.
• Experience managing external manufacturing/CDMOs for biologics or cell therapy.
• Authorized to work in the U.S.
• Ability to travel up to 20%.

Nice to have

• Direct experience with viral vector manufacturing.
• Knowledge of cell and gene therapy processes.
• Late-stage clinical and commercial experience.
• Experience with CMC regulatory submissions.

Culture & Benefits

• Collaborative work environment with a team of talented professionals.
• Comprehensive benefits package including health insurance and equity.
• Annual performance bonus.
• Generous time off, including two annual company-wide holiday shutdowns.