Senior Manager, External Manufacturing (Biotech)

TL;DR

Senior Manager, External Manufacturing (Biotech): Overseeing external manufacturing operations for allogeneic CAR T cell products with an accent on gene-editing and late-stage qualification. Focus on managing CDMO relationships, ensuring regulatory compliance, and optimizing the end-to-end supply chain for cancer and autoimmune disease therapies.

Location: Onsite in South San Francisco or Newark, CA. Candidates must be authorized to work in the U.S.

Salary: $155,000 – $180,000 per year

Company

Clinical-stage biotechnology company pioneering the development of off-the-shelf 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) including Quality, Supply Chain, and MSAT to achieve program objectives.
• Establish and manage critical manufacturing agreements, including MSAs and SOWs.
• Partner with Quality Assurance to ensure timely product release and implementation of CAPAs.
• Develop and monitor CDMO performance using KPIs and lead continuous improvement projects.
• Collaborate with Supply Planning to perform capacity analysis and ensure demand fulfillment.

Requirements

• Bachelor’s degree in science or engineering.
• Minimum of 8 years of directly related GMP pharmaceutical manufacturing experience.
• Experience managing external manufacturing/CDMOs for biologics or cell therapy.
• Knowledge of pharmaceutical manufacturing processes.
• Ability to travel up to 20%.
• Authorization to work in the U.S.

Nice to have

• Direct experience with RNA and/or protein manufacturing.
• Knowledge of cell/gene therapy processes.
• Experience with late-stage clinical and commercial manufacturing.
• Experience with CMC regulatory submissions.

Culture & Benefits

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