Associate Director, Drug Substance Manufacturing – Downstream Process

About the Company

Vera Therapeutics is a commercial-stage biotechnology company focused on transforming medicine in autoimmune disease, starting with the kidney. Our flagship commercial product is TRUTAKNA™ (atacicept-vymj), a B-cell activating factor (BAFF) and A proliferation-inducing ligand (APRIL) inhibitor. We evaluate multiple diseases where reducing autoantibodies through inhibition of BAFF and APRIL may prove clinically meaningful. Founded in 2016 and based in Brisbane, California, Vera Therapeutics is built on values of empathy, clarity, ownership, and urgency—guided by the needs of patients.

About the Role

The Associate Director, Drug Substance Manufacturing – Downstream Process will report to the VP, Commercial Manufacturing Operations and serve as the subject matter expert (SME) in downstream processes for outsourced drug-substance manufacturing, technology transfer, lifecycle management, and global regulatory submissions of complex biologics, monoclonal antibodies, and other recombinant therapeutics. This role requires leadership in overseeing all drug-substance downstream manufacturing activities at CMO sites, including process scale-up, technology transfers, validations, PPQ campaign support, continuous process improvements, and post-approval lifecycle management. The position also involves authoring, reviewing, and editing CMC-related regulatory submissions and quality documents.

Responsibilities

• Technical Oversight & Manufacturing Support
  • Serve as the 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.
  • Promote 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 and process improvement strategies.
  • Facilitate execution using digital tools (e.g., big data modeling) for commercial products across manufacturing sites.
  • Establish and maintain robust process monitoring and Continuous Process Verification (CPV) protocols.
• CMC & Regulatory Support
  • Author and review CMC sections for global regulatory submissions (NDA, BLA, MAA, ND, IPMD).
  • Support filings in new markets and conduct impact assessments for post-approval changes.
  • Respond to health authority questions related to manufacturing processes and controls.
  • Ensure manufacturing and validation strategies align with GMP, ICH, and global regulatory expectations.

Qualifications

• MS in a relevant life sciences or engineering discipline with a minimum of 5 years of experience in the pharmaceutical/biotechnology industry (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 managing US/international CDMOs to 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 mitigating risks.
• Critical thinking and problem-solving skills with the ability to drive risk-based decision-making.
• Strong organizational and project management skills, including proficiency with MS Project and other tools.
• Excellent communication and interpersonal skills for collaboration across the organization.

Pay

The anticipated base pay range for this role is $175,000 - $210,000 USD, depending on geography, qualifications, skills, and experience.

Benefits

• Annual performance incentive bonus.
• New hire equity and ongoing performance-based equity.
• Medical, dental, and vision insurance.
• 401k match.
• Flexible time off and paid holidays.