CDMO Manager, External Manufacturing (Contract)

Adverum Biotechnologies, Inc. • Redwood City, CA

32d • $60 - $70 • Remote

About The Position

Adverum Biotechnologies, Inc., a subsidiary of Eli Lilly and Company, is a clinical-stage company focused on developing gene therapy for ocular diseases. They are seeking a remote CDMO Manager, External Manufacturing, who will travel frequently to contract manufacturing development organizations (CDMOs). This role supports GMP manufacturing operations, development, and engineering work, with a primary focus on AAV/gene therapy drug substance manufacturing for late-stage clinical trials and process validation (PPQ). The position involves interaction with internal quality, supply chain, process development, regulatory affairs, and finance teams to oversee and coordinate CDMO activities.

Requirements

• Bachelor’s degree in scientific or engineering discipline.
• Minimum of 8 years of experience in manufacturing management, preferably in a contract manufacturing environment.
• Drug Substance Viral Vector/AAV or biologics experience in either upstream or downstream operations.
• Strong understanding of relevant manufacturing processes, aseptic processing, quality control, and regulatory compliance in the industry.
• Proven track record of managing external manufacturing partners and driving operational excellence.
• Excellent leadership, communication, and negotiation skills.
• Ability to manage multiple projects and priorities in a fast-paced environment.
• Ability to gown into and work in clean rooms.

Nice To Haves

• Knowledge of Lean Manufacturing, Six Sigma, or other process improvement methodologies.
• Process Validation / PPQ experience / Commercial Manufacturing
• Drug Product experience
• Master’s degree or Phd

Responsibilities

• Oversee day-to-day operations at contract manufacturing sites to ensure production targets are met and quality standards are maintained.
• Serve as the secondary point of contact between Adverum and CMO(s), ensuring clear and effective communication.
• Monitor and assess the performance of contract manufacturing partners, implementing improvement plans as needed.
• Coordinate with contract manufacturers to schedule production runs, ensuring that products are manufactured on time and within budget.
• Monitor production processes to ensure compliance with company specifications, regulatory requirements, and industry standards and current best practices.
• Address and, if needed, escalate any production issues or delays promptly, working with contract manufacturers to develop and implement solutions.
• Review and approval of manufacturing documentation (MBRs, specifications, change controls, deviations, etc.)
• Ensure that all products manufactured at contract sites meet Adverum’s quality standards and comply with relevant regulations.
• Collaborate with Quality Assurance teams to schedule audits, inspections, and quality checks at contract manufacturing sites.
• Monitor corrective and preventive actions (CAPA) that are implemented to address any quality issues or deviations from standards.
• Work closely with the Supply Chain team to manage the flow of materials and finished products between Adverum and CDMO(s).
• Ensure that contract manufacturers have the necessary raw materials, equipment, and resources to meet production needs.
• Monitor inventory levels at contract sites to prevent stock-outs or excess stock of any required materials.
• Monitor and manage production costs at contract manufacturing sites to ensure alignment with budgetary goals.
• Identify opportunities for cost savings and efficiency improvements in the manufacturing process.
• Ensure that all manufacturing activities at contract sites comply with applicable regulations, including GMP, FDA, ISO, and other relevant standards.
• Maintain up-to-date knowledge of regulatory requirements and industry best practices.
• Lead efforts to implement and maintain compliance programs at contract manufacturing sites.
• Drive continuous improvement initiatives at contract manufacturing sites to enhance product quality, production efficiency, and operational effectiveness.
• Collaborate with cross-functional teams to identify and implement process improvements.
• Track and report on key performance indicators (KPIs) related to contract manufacturing performance.
• Identify and mitigate risks associated with contract manufacturing operations, including supply chain disruptions, quality issues, and regulatory compliance challenges.
• Develop contingency plans to address potential disruptions and ensure continuity of supply.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior