SAP
MacKenzie McGrath
Lynn,MA
Summary
Experienced self-starter with a proven track record in the pharmaceutical industry. Focused and confident leader skilled in managing project cost, schedule, scope, resources, and risks. Possesses extensive knowledge in these areas, consistently delivering successful outcomes while ensuring efficiency and compliance.
Overview
7
7
years of professional experience
Work History
Project Consultant
Arcadis(DPS)
12.2020 - Current
- Operated as project consultant for Arcais (DPS) in Greater Boston Area
- Have worked on 10+ projects across all clients in pharmaceutical industry for R&D and CMC
Engineering Project Coordinator
Moderna
05.2023 - Current
- Created and manage Engineering Capital Projects project portfolio averaging 50+ active projects
- Coordinate project teams, reports, data and schedule for select projects
- Manage global project controls closeout process
- Coordinate with vendors and contractors on outstanding work
- Onboard service providers for project teams
- Review and report on changes to capital projects cost, scope and schedule
- Coordinate globally with cost controllers on quarter and annual estimates and forecasting
- Train new cost controllers on SAP usage
- Recommend department improvements on portfolio reporting and management.
Raw Material Project Manager/Lead
Sanofi
08.2021 - 04.2023
- Managed onboarding of raw materials and consumables for Engineering, Shakedown and PPQ
- Coordinated with QC to ensure material Validation and Qualification was completed per project timeline
- Managed recurring meetings with SMEs and maintained meeting minutes
- Updated dashboards and slides for SLT and project sponsors
- Monitored and supported open orders with suppliers with pending materials for PPQ
- Communicate with suppliers on requirements for onboarding
- Created and managed trackers to ensure transparency to all departments on status of materials and responsibility
- Support Tech Transfer activities for new site
- Averaged managing 5 projects .
- Identified plans and resources required to meet project goals and objectives.
Technical Compliance Officer and Project Coordinator
Sanofi Pharmaceuticals
12.2020 - 05.2022
- Technical writer for HA isolator implementation project
- Managed technical writing team to ensure expectations and schedule dates were met
- Initiated and maintained document workflows for procedures, Protocols and Reports
- Initiated and managed new material and new service provider requests
- Scrum meeting lead
- Observe operations for procedure edits for CharePoint Valve, Isolator EMS System, Steris VHP and SWECO
- Updated project schedule from communications with project leads
- Managed new raw material for IQ, PQ, Engineering Runs, Shakedown, Media Fills and PPQ.
Quality Manager & SQF Practitioner
ePac Flexible Packaging
02.2019 - 12.2020
- Preformed Batch Record review and release for product
- Managed and Led Implementation of GMP systems and SQF-2 Code Requirements (93/100 for initial certification)
- Provide quality oversight on system changes, risk assessments and effectiveness checks
- Support new equipment and material implementation (Totani, PCR Film and Henkel Adhesive)
- Troubleshoot equipment issues (Nordmecanica Laminator, Karlville Slitter, Totani Pouch Machine)
- Installation of quality control equipment (Haug Tank, Universal Tester MT-1500)
- Provide support to warehousing and inventory operators on raw material inspection, investigations and rejection
- Perform Internal Audits and GMP inspections for site.
Quality Control Analyst I
Alnylam
05.2018 - 02.2019
- Contributed to launch of Onpattro
- Ran data verification for regulatory submissions (IMPD/IND/NDA)
- Provided QC PM timelines for cGMP QC documents
- Served as SME for QC specifications and stability during regulatory inspections
- Initiated communication of specification updates to SRB and provided timelines to CMC.
Quality Control (Co-op)
AMAG Pharmaceuticals
07.2017 - 12.2017
- Analyzed, reviewed and created analytical method life cycle, stability, drug product and drug substance-control charts for QC and Technical Operations
- Edited effective batch records
- Collaborated with process engineer on investigations and validations
- Created SCN’s for Technical Operations and Quality Assurance.
Education
Bachelor of Science, Chemical Engineering -
Northeastern University
Boston, MA05.2018
Skills
- Continuous Improvement
- Compliance Monitoring
- Risk Management
- Schedule Management
- Resource Allocation
- Process Improvement
- Project Implementation
- Project Leadership
- Project Analysis
- Project Management
- Root Cause Analysis
- Cost Control
Competenciesandcertifications
- SOPs, Specifications, Protocols and Reporting
- SmartSheets, MasterControl, VeevaVault, Google Suite, Microsoft Applications, SAP, Geode+
- CQV and Operational Readiness
- Internal Auditing & GMP Inspection
- SQF Practitioner
- Risk Assessment
- Scrum and Agile Mindset
Software
Microsoft Office
SmartSheet
Procore
Veeva Vault and Geode
Timeline
Engineering Project Coordinator
Moderna
05.2023 - Current
Raw Material Project Manager/Lead
Sanofi
08.2021 - 04.2023
Project Consultant
Arcadis(DPS)
12.2020 - Current
Technical Compliance Officer and Project Coordinator
Sanofi Pharmaceuticals
12.2020 - 05.2022
Quality Manager & SQF Practitioner
ePac Flexible Packaging
02.2019 - 12.2020
Quality Control Analyst I
Alnylam
05.2018 - 02.2019
Quality Control (Co-op)
AMAG Pharmaceuticals
07.2017 - 12.2017
Bachelor of Science, Chemical Engineering -
Northeastern University
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