CDMO Manager, External Manufacturing – Contract

Adverum Biotechnologies

CDMO Manager overseeing contract manufacturing operations for gene therapy development at Adverum Biotechnologies. Responsible for quality compliance, production oversight, and cost management with frequent travel.

Posted 5/26/2026contractRedwood City • California • 🇺🇸 United StatesSeniorLead💰 $60 - $70 per hourWebsite

About the role

Key responsibilities & impact

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.

Requirements

What you’ll need

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.
30% (or more depending on needs) travel to CDMO(s). Ability to gown into and work in clean rooms.
Preferable Attributes/Experience:
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.

Benefits

Comp & perks

🌐 Worldwide ❌ Jobs You've Hidden ⭐️ Saved Jobs ✅ Applied Jobs ✉️ Email Alerts 👤 Account Adverum Biotechnologies Website LinkedIn All Job Openings 51 - 200 employees Founded 2013 🧬 Biotechnology 💊 Pharmaceuticals 💰 $217M Post-IPO Equity on 2020-08 Biotechnology
Pharmaceuticals Adverum Biotechnologies is a company focused on developing gene therapies to treat debilitating ocular diseases. Their mission is to establish gene therapy as a new standard of care, particularly in treating conditions like wet age-related macular degeneration (wet AMD), which is a leading cause of blindness globally. The company is advancing their investigational gene therapy Ixo-vec, designed to provide a long-lasting treatment through a single in-office administration, which could replace the current standard of frequent and painful eye injections. By leveraging their proprietary adeno-associated virus (AAV) vector platform, Adverum aims to transform the standard of care, improve accessibility to treatment, and achieve significant societal impact by restoring vision and preventing blindness. CDMO Manager, External Manufacturing – Contract 🔥 1 hour ago 🏢🏡 Redwood City – Hybrid 💵 $60 - $70 / hour ⏳ Contract/Temporary 🟠 Senior 🔴 Lead 👔 Manager 🦅 H1B Visa Sponsor Apply Now Find Hiring Managers Customize resume + cover letter Report problem ☆ Save ☑️ Mark as applied ❌ Hide 📋 Description
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. 🎯 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.
30% (or more depending on needs) travel to CDMO(s). Ability to gown into and work in clean rooms.
Preferable Attributes/Experience:
Knowledge of Lean Manufacturing, Six Sigma, or other process improvement methodologies.
Process Validation / PPQ experience / Commercial Manufacturing.
Drug Product experience.
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Hard Skills & Tools

manufacturing managementquality controlregulatory complianceprocess validationlean manufacturingsix sigmaaseptic processingdrug substance viral vectorbiologicscommercial manufacturing

Soft Skills

leadershipcommunicationnegotiationproject managementproblem-solvingcollaborationorganizational skillsadaptabilityattention to detailcontinuous improvement

Certifications

Bachelor’s degreeMaster’s degreePhD