Associate Director, Drug Substance Manufacturing – Upstream Process

Vera Therapeutics, Inc.

. Serve as subject matter expert in upstream processes for outsourced drug-substance manufacturing, technology transfer, lifecycle management, and global regulatory submissions for complex biologics, monoclonal antibodies, and recombinant therapeutics .

Posted 10/6/2026full-timeRemote • California • United StatesSenior💰 $175,000 - $210,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in upstream processes for biologics drug substance manufacturing, technology transfer, and regulatory submissions, with a strong focus on continuous improvement and compliance with GMP and ICH standards.

Highest-signal resume keywords

Upstream ProcessingTechnology TransferProcess ValidationProject ManagementRegulatory Submissions

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Cell CultureCell Bank ManagementStatistical AnalysisProcess OptimizationCAPA ImplementationLifecycle Management StrategiesContinuous Process VerificationTechnical DocumentationRisk ManagementProcess Development

Soft Skills

Critical ThinkingProblem-SolvingOrganizational SkillsInterpersonal SkillsCommunication Skills

Tools & Technologies

MS ProjectDigital Tools

Industry Keywords

BiologicsMonoclonal AntibodiesRecombinant TherapeuticsCGMP ManufacturingNDABLAMAACDMOPharmaceutical IndustryBiotechnology Industry

About the role

Key responsibilities & impact

Serve as subject matter expert in upstream processes for outsourced drug-substance manufacturing, technology transfer, lifecycle management, and global regulatory submissions for complex biologics, monoclonal antibodies, and recombinant therapeutics
Serve as primary technical interface with global CMOs supporting drug substance upstream activities
Lead technical deviation investigations, 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, industry benchmarking, and knowledge-sharing across teams
Perform statistical analysis on campaign data to create and analyze process trends and control charts
Develop lifecycle management and process improvement strategies and facilitate execution using digital tools
Establish and maintain process monitoring and Continuous Process Verification (CPV) protocols and procedures
Author and review CMC sections for NDA, BLA, and MAA submissions
Support new-market filings, post-approval change impact assessments, and responses to health authority questions
Ensure manufacturing and validation strategies align with GMP, ICH, and global regulatory expectations
Report to the VP, Commercial Manufacturing Operations and collaborate with CMC, project management, QA, and Regulatory teams

Requirements

What you’ll need

MS in relevant life sciences or engineering discipline with a minimum of 5 years of Pharmaceutical/Biotechnology industry experience in biologics drug substance upstream processes, technology transfer, and cGMP manufacturing operations, or BS with 8 years of experience
Experience in process development and/or manufacturing sciences and technology (MSAT) is preferred
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 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 managing risks
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

Benefits

Comp & perks

Annual performance incentive bonus
New hire equity
Ongoing performance-based equity
Medical insurance
Dental insurance
Vision insurance
401k match
Flexible time off
Paid holidays