Adverum Biotechnologies

Manager

• 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.

CDMO Manager, External Manufacturing – Contract

QA Engineer

• Assisting with system administration of MasterControl EQMS.
• Lifecycle management of controlled documents including creation, review, approval, and retirement per the internal QMS and SOPs.
• Lifecycle management of training courses including creation, review, approval, and retirement.
• Support version upgrades and continuous improvement efforts of MasterControl, including configuration and testing of new modules.
• Train current users and new users on MasterControl roles.
• Support resolving system related issues, and ensuring records are processed according to procedures and guidelines.
• Troubleshoot and provide solutions to challenges in the MasterControl EQMS.
• Prepare quality metrics and report.
• Provide staff support regarding quality systems, including maintenance of logs, facilitating timely closure of records and providing QA review as appropriate.
• Facilitate the document change request process, including providing formatting assistance, coordinating the review/approval process, tracking and routing of controlled documents.
• Manage the Document Control room, ensuring data integrity and inspection readiness.
• Maintain electronic and hardcopy history files of controlled documents, ensuring accurate and reliable filing systems.
• Initiates updates and creation of new SOPs as required.
• Copy, scan, and distribute controlled documents as needed.
• Issue, track and/or reconcile controlled test record forms, logbooks and laboratory notebooks.

QA Manager, Document Control – Contract

Research Scientist

• Support late‑stage AAV downstream process development and optimization to ensure scalability, robustness, reproducibility, and regulatory compliance.
• Lead and execute purification development, including chromatography (AFF, IEX) and filtration (depth, NFF, TFF).
• Individually and partner with other SMEs to author protocols and reports, and execute on process characterization and validation studies (FMEA, scale‑down models, DOE/OFAT, PPQ, hold studies).
• Compile and analyze process and analytical data in Excel, JMP, or similar software, to identify trends, drive optimization, and lead and support investigations / RCA.
• Present study findings, issues, and trends to PD and cross-functional CMC teams.
• Support downstream material generation team as needed to maintain company timelines.
• Downstream SME to support external manufacturing operations including technical meetings, BPR and related records review, execution, and troubleshooting.
• Collaborate cross‑functionally (AD, USP, QC, RA) to ensure seamless transition from development to commercial.
• Provide line leadership if needed.
• Author/review technical documentation (development reports, SOPs, CMC sections for regulatory filings, Process Monitoring and Control Strategies).
• Stay updated on industry trends and emerging technologies in gene therapy manufacturing to maintain best-in-class process development practices.

Principal Scientist – Downstream Process Development

• Manage all QC Release and Stability sample testing activities at all CTLs, including but not limited to, sample and reagent shipment coordination, shipment temptale review, updated test method review/approval, advise on lab scheduling and test priority, support problem solving activities at CTLs for test directives, support OOS/OOE/OOT/Atypical lab investigations, final test data COA review/acceptance.
• Manager/support method transfer and method validation activities at CTLs and CMOs, including but not limited to, protocol review/approval, reagent shipment coordination, method validation design and document review/approval, validation data packet evaluation, final report review/approval.
• Author and revise internal SOPs, forms, and documentation related to CTL management, data review, and lab investigation activities.
• Support CTL and CMO lab audit activities if needed.
• Participate in internal audits, external inspections, and quality system assessments by providing documentation and subject‑matter expertise.
• Collaborate cross‑functionally with QC, QA, Manufacturing, Supply Chain, and Facilities to improve processes, reduce risks, and strengthen compliance.
• Contribute to continuous improvement initiatives to streamline laboratory workflows and enhance data integrity.

Quality Control Manager – Contract Testing Lab

Data Scientist

• Responsible for compliance with regulatory and ICH guidelines, GCPs, company guidelines and Standard Operating Procedures, and CDM best practices.
• Independently serves as the lead point of contact for all data management study-related communications.
• Independently leads EDC development, including CRF development, EDC specification process, edit check development and User Acceptance Testing including test scripts and execution logs, issue logs, and UAT summary reports.
• Reviews and assists in the development of study documents drafted by CROs such as Data Management Plans, Data Validation Specifications, eCRF Completion Guidelines, Data Review Plans, Data Transfer Agreements, and other cross-functional study documents that may require data management input.
• Ensures the quality of clinical data within the EDC and other databases through regular data review and external data reconciliation processes and communicates any outstanding issues to the cross-functional teams.
• Monitors and tracks the quality of all data management deliverables.
• Leads data deliverables including snapshots for DMC, investor relations, publications, etc., and interim and final database locks, in collaboration with the CRO DM Vendor.
• Effectively oversees contracted vendors, or vendor groups within CRO, to ensure data are complete, accurate and delivered within agreed on timelines.
• Leads and facilitates Data Review Meetings with the cross-functional team, presenting metrics, trends, risks, and or issues.
• Actively participates in team meetings – DM or cross-functional.
• Coordinates transfers of SAS datasets or external data transfers from CROs.
• Support TFL reviews, yearly regulatory submission requirements, compilation of CSRs, etc.
• Responsible for TMF maintenance of data management-related study documents.
• Responsible for archiving trial(s) and associated documentation upon trial(s) completion.

CDMO Manager, External Manufacturing – Contract

QA Manager, Document Control – Contract

Principal Scientist – Downstream Process Development

Quality Control Manager – Contract Testing Lab

Clinical Data Manager – Contract