Michael Alibrandi
Quincy
Summary
Results-driven Clinical Supply Chain Planner with proven expertise in materials management and production planning. Adept at ensuring regulatory compliance and fostering cross-functional collaboration to achieve operational efficiency.
Overview
4
4
years of professional experience
Work History
Clinical Supply Chain Planner
Alnylam Pharmaceuticals
Cambridge, MA
05.2025 - Current
- Manage departmental documentation across regulated repositories (eTMF, eQMS, Box, SharePoint).
- Serve as a key resource for clinical supply internal systems and processes.
- Coordinate preparation of materials, agendas, and presentations for internal and cross-functional meetings.
- Support contract processing, invoicing, and purchase order tracking.
- Organize daily operational documents and maintain knowledge repositories.
- Initiate and support cross-departmental projects within Clinical Supply Chain.
- Assist with onboarding and training of new team members.
- Provide project management and operational support across teams while maintaining confidentiality and compliance.
Quality Assurance Associate I
Moderna
Burlington, MA
08.2023 - 11.2024
- Supported disposition of DNA manufacturing batch records and quality oversight of GMP operations.
- Reviewed batch records, testing documentation, and manufacturing data to ensure compliance with specifications and SOPs.
- Managed deviations, CAPAs, change controls, quality events, MBRs, and SOPs using Veeva QMS.
- Identified quality risks, escalated issues, and supported corrective action planning.
- Partnered cross-functionally with Manufacturing, Quality Operations, Logistics, and Process Development teams.
- Conducted on-the-floor quality oversight during manufacturing operations.
- Trained new hires on GMP processes and quality systems.
- Supported environmental monitoring and EHS-related documentation.
- Contributed to continuous improvement initiatives and inspection readiness.
Manufacturing Engineer I
Moderna
Burlington, MA
03.2023 - 08.2023
- Participated in cross-functional troubleshooting and operational improvements in GMP manufacturing.
- Supported technology transfer activities and documentation of process parameters.
- Assisted with deviation investigations, root cause analyses, CAPAs, and change controls.
- Tracked manufacturing performance metrics and project milestones.
- Maintained manufacturing data repositories and supported process optimization efforts.
Quality Assurance Associate I
Organogenesis, Inc.
Canton, MA
10.2022 - 03.2023
- Performed inspections of medical devices in cleanroom environments.
- Managed document control activities and ensured GDP compliance.
- Supported post-market OOS and OOT investigations.
- Conducted on-the-floor QA inspections and SOP compliance checks.
- Ensured labeling accuracy, material traceability, and batch documentation compliance.
- Maintained compliance with cGMP, ISO, and EHS standards.
Manufacturing Associate I
Organogenesis, Inc.
Canton, MA
01.2022 - 10.2022
- Manufactured allograft products in accordance with MBRs and SOPs.
- Prepared production media and sanitizing agents for cleanroom environments.
- Maintained accurate batch records and supported GMP documentation requirements.
- Ensured materials and chemicals were properly labeled, stored, and compliant with EHS standards.
Education
Bachelor of Science - Business Management
Curry College
Milton05-2018
Skills
- Materials management
- Production planning
- Cost reduction
- Capacity planning
- GMP / cGMP Compliance
- Batch Record Review & Disposition
- Deviations, CAPAs, Change Controls
- Clinical Supply Chain Operations
- Quality Management Systems (QMS)
- SOPs, MBRs, BRs, GDP
- Audit Readiness & Documentation Control
- Cross-Functional Collaboration
- Root Cause Analysis
- Metrics & Quality Events
- Training & Onboarding
- EHS & Cleanroom Operations
- Veeva QMS
- SAP
- TrackWise
- eTMF
- SharePoint / Box
- Microsoft Office Suite
- FDA / EMA Regulations
- cGMP / GxP
- ISO Standards
- EHS Codes
- Audit Readiness
Timeline
Clinical Supply Chain Planner
Alnylam Pharmaceuticals
05.2025 - Current
Quality Assurance Associate I
Moderna
08.2023 - 11.2024
Manufacturing Engineer I
Moderna
03.2023 - 08.2023
Quality Assurance Associate I
Organogenesis, Inc.
10.2022 - 03.2023
Manufacturing Associate I
Organogenesis, Inc.
01.2022 - 10.2022
Bachelor of Science - Business Management
Curry College