Associate Director, Drug Substance Manufacturing – Downstream Process

Associate Director, Drug Substance Manufacturing – Downstream Process

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. Vera Therapeutics' flagship commercial product is TRUTAKNATEM (atacicept-vymj), a B-cell activating factor (BAFF) and A proliferation-inducing ligand (APRIL) inhibitor. Vera Therapeutics is evaluating multiple diseases where the reduction of autoantibodies through inhibition of BAFF and APRIL may prove clinically meaningful.

Vera Therapeutics was founded in 2016 and is based in Brisbane, California.

At Vera, our values are the cornerstone of our culture and guide how we work together every day. We lead with empathy, act with an owner's mindset, demand clarity, work without fences, and execute with urgency because patients are counting on us. From how we hire and develop our people to how we advance rigorous science, we are building a team committed to transforming medicine in autoimmune diseases, starting with the kidney.

The Associate Director, Drug Substance Manufacturing – Downstream Process will report to the VP, Commercial Manufacturing Operations and will be responsible all aspects of Drug Substance (DS) manufacturing with expertise in downstream processing. The individual will serve as a subject matter expert (SME) in downstream processes for outsourced drug-substance manufacturing, technology transfer, life cycle management, and global regulatory submissions of complex Biologics, monoclonal antibodies, and other recombinant therapeutics.

Technical Oversight & Manufacturing Support

• Serve as primary technical interface with global CMOs supporting Drug Substance manufacturing downstream activities.
• Lead investigations for technical deviations, root cause analyses, and CAPA implementation.
• Supervise campaign readiness, change management, and process development discussions.
• Lead internal technical meetings and contribute to managing timelines, supply impact, risks, and budget.

Technology Transfer & Validation

• Oversee technology transfer, PPQ readiness, and validations across CMO sites.
• Author and review validation protocols, reports, and technical documentation.
• Drive continuous improvement initiatives across downstream processes.
• Drive standardization and knowledge-sharing practices across sites and the global network.

Lifecycle Management & CPV

• 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. Facilitate execution utilizing digital tools (e.g., big data modelling tools), as applicable, for commercial products across manufacturing sites.
• Establish and maintain robust process monitoring and Continuous Process Verification (CPV) protocols /procedures

CMC & Regulatory Support

• Author and review CMC sections for global regulatory submissions (NDA, BLA, MAA, ND, IPMD)
• Support filing in new markets and conduct impact assessment to post‑approval changes.
• Support responses to health authority questions related to manufacturing processes and controls.
• Ensure manufacturing and validation strategies align with GMP, ICH, and global regulatory expectations.

• 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 downstream processes, technology transfer, and cGMP manufacturing operations.
• Extensive hands-on experience in downstream unit operations including chromatography, UF/DF, Viral clearance, and other protein purification methodologies.
• 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. Track record of successfully driving and managing programs, overcoming challenges, and managing risks.
• Critical thinking and…