Associate Director, Drug Substance Manufacturing – Upstream Process

The role

The Associate Director will be responsible for all aspects of Drug Substance biologics manufacturing with expertise in upstream processing. This person will serve as a subject matter expert for outsourced manufacturing, technology transfer, life cycle management, and global regulatory submissions.

What you will do

• Serve as primary technical interface with global CMOs supporting Drug Substance manufacturing upstream activities.
• Lead investigations for technical deviations, root cause analyses, and CAPA implementation.
• Supervise campaign readiness, change management, and process optimization discussions.
• Lead internal technical meetings and contribute to managing timelines, supply impact, risks, and budget.
• Oversee technology transfer and process qualification across CMO sites.
• Author and review validation protocols, reports, and technical documentation.
• Drive continuous improvement initiatives across upstream processes.
• Perform statistical analysis on campaign data to create and analyze process trends and control charts.
• Develop near-term and long-term lifecycle management / process improvement strategies.
• Author and review CMC sections for global regulatory submissions (NDA, BLA, MAA).

Required qualifications

• MS in relevant life sciences or engineering discipline with a minimum of 5 years of Pharmaceutical/Biotechnology industry experience (or BS with 8 years of experience) in biologics drug substance upst
• Extensive hands-on experience in upstream processing including cell bank management, cell culture (expansion and production), and harvest.
• Working knowledge of technology transfer, process validation, and routine management of GMP manufacturing.
• Experience in managing US/international CDMOs to help support commercial manufacturing of biologic drugs.
• Proven leadership and cross-functional management of CMC-related programs.
• Critical thinking and problem-solving skills with ability to drive risk-based decision making.
• Strong organizational and project management skills, including proficient use of MS Project and other tools.
• Excellent communication and interpersonal skills in working across the organization.

Nice to have

• Experience in process development and/or manufacturing sciences and technology (MSAT) is preferred.

Benefits

• medical, dental, and vision insurance
• 401k match
• flexible time off
• paid holidays

About the company

Vera Therapeutics is a commercial-stage biotechnology company focused on the pursuit of truth in science to transform medicine in autoimmune disease, starting with the kidney. The company was founded in 2016 and is based in Brisbane, California.