CDMO Manager, External Manufacturing (Contract)

Adverum Biotechnologies•Redwood City, CA

4d•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 CDMO Manager, External Manufacturing, to join their remote team. This role will involve supporting GMP manufacturing operations at contract manufacturing development organizations (CDMOs), focusing on AAV/gene therapy drug substance manufacturing for late-stage clinical trials and process validation. The position requires 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.