CDMO Manager, External Manufacturing (Contract)

United States·Redwood CityContractmid

OtherManufacturing

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Requirements Summary

Ensure that all products manufactured at contract sites meet Adverum’s quality standards and comply with relevant regulations. Collaborate with Quality Assuran

Technical Tools

OtherManufacturing

Adverum Biotechnologies, Inc., wholly owned subsidiary of Eli Lilly and Company, is a mission-driven clinical-stage company that aims to establish gene therapy as a new standard of care for highly prevalent ocular diseases with the aspiration of developing functional cures to restore vision and prevent blindness. Leveraging the research capabilities of its proprietary intravitreal (IVT) platform, Adverum is developing durable, single-administration therapies designed to be delivered in physicians’ offices to eliminate the need for frequent ocular injections to treat these diseases. By overcoming the challenges associated with current treatment paradigms for these debilitating ocular diseases, Adverum aspires to transform the standard of care, preserve vision, and create a profound societal impact around the globe.

All recruiter and agency inquiries must go through Adverum’s internal Talent Acquisition team. Unsolicited resumes sent to Adverum will be considered property of Adverum. Agencies must be expressly engaged by Adverum’s Talent Acquisition team for any requisition. Direct contact with hiring managers by agencies will not be tolerated and may affect your ability to work with Adverum in the future.

Adverum is looking for a CDMO Manager, External Manufacturing, to join our team remotely and travel often to Adverum’s contract manufacturing development organization(s)s (CDMO). The CDMO Manager, External Manufacturing, will be responsible for supporting GMP manufacturing operations at Adverum’s CDMO and activities related to the GMP production as well as supporting development and engineering work. This role is primarily focused on CDMO(s) for AAV/gene therapy drug substance manufacturing for late-stage clinical trials and process validation (PPQ). 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.

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.

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