Adverum is looking for a Site Manager, External Manufacturing, to join our team remotely and travel often to Adverum’s contract manufacturing development organization(s)s (CDMO). The Site Manager, External Manufacturing, will be responsible for managing daily interaction and overseeing operations at Adverum’s CDMO and activities related to the GMP production as well as supporting manufacturing activities for development and engineering work. This role is primarily focused on CDMO(s) for AAV/gene therapy drug substance manufacturing. This role interacts with cross functional team members from internal quality, supply chain, process development, regulatory affairs, and finance in order to provide oversight and coordination of CDMO related activities.
What you’ll do:
- Site Management:
- 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.
- Production Oversight:
- 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.
- Quality Compliance:
- 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.
- Supply Chain Coordination:
- 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.
- Cost Management:
- 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.
- Regulatory Compliance:
- 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.
- Continuous Improvement:
- 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.
- Risk Management:
- 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.
About You:
- 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).
- Knowledge of Lean Manufacturing, Six Sigma, or other process improvement methodologies is a plus.
- 30% (or more depending on needs) travel to CDMO(s).
- Up to 90% of time will be spent at CDMO
Adverum is a clinical-stage gene therapy company targeting unmet medical needs in ophthalmology and rare diseases. Adverum develops gene therapy product candidates designed to provide durable efficacy by inducing sustained expression of a therapeutic protein. Adverum’s core capabilities include clinical development, novel vector discovery and in-house manufacturing expertise, specifically in scalable process development, assay development, and current Good Manufacturing Practices quality control. At Adverum, Inclusion and Diversity are at our core.
We believe in the power of being your authentic self. We strive to create the space which allows for everyone in our Adverum Community to not only feel safe but encouraged to speak, learn from each other, grow in their professions and be the very best versions of themselves no matter what their age, ethnic background, gender, origin, religion or sexual orientation Apply for this job
