Remote Site Manager, External Manufacturing

Summary

Join Adverum as a Site Manager, External Manufacturing, to oversee daily operations at contract manufacturing sites and ensure production targets are met and quality standards are maintained.

Requirements

• Bachelor’s degree in engineering, Manufacturing, Supply Chain Management, or a related field (Master’s degree preferred)
• Minimum of 8 years of experience in manufacturing management, preferably in a contract manufacturing environment
• 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
• Proficiency in manufacturing and supply chain management software (e.g., SAP, Oracle)

Responsibilities

• Oversee day-to-day operations at contract manufacturing sites to ensure production targets are met and quality standards are maintained
• Serve as the primary 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
• 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
• Negotiate terms and pricing with contract manufacturing sites and other service providers to achieve favorable outcomes for Adverum
• 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

Preferred Qualifications

Knowledge of Lean Manufacturing, Six Sigma, or other process improvement methodologies is a plus