Associate Director, Drug Substance Manufacturing – Upstream Process

🕒 il y a 24 jours

🏄 California – Distant

🏄 California – Remote

💵 $175 000 - $210 000 / an

⏰ Temps Plein

🟠 Senior

👔 Directeur

👻 Score fantôme 0%

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Vera Therapeutics, Inc.

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201 - 500 employés

🏥 Santé

💼 Conseil

🧬 Biotechnologie

Healthcare • Consulting • Biotechnology

Vera Therapeutics, Inc. est une société de biotechnologie en phase clinique, spécialisée dans le développement de traitements pour les maladies rénales immunologiques, améliorant ainsi la vie des patients. L'entreprise fait progresser l'Atacicept à travers le développement clinique pour la néphropathie à IgA (IgAN), menant des essais de phase 2b et 3, et poursuit des programmes dans la néphrite lupique et d'autres affections immunologiques. Basée à Brisbane, Californie, Vera met l'accent sur le développement de médicaments basé sur la science, l'engagement des patients et la durabilité.

Description

• 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

🎯 Exigences

• 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

🏖️ Avantages

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

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