Supply Chain Regulatory Compliance
Resume:
Loi N. Luu
Alameda, CA
***.***@*****.***
PROFILE SUMMARY
Results-driven Supply Chain & CMC Management professional with extensive experience in the pharmaceutical industry across clinical (Phase 1-4), commercial, and global supply chain operations. Proven expertise in supply chain optimization, vendor management, regulatory compliance, and cross-functional collaboration to ensure seamless drug development and distribution. Adept at leading multidisciplinary teams to drive operational excellence and efficiency in high-pressure environments.
Core Competencies:
oClinical & Commercial Supply Chain Management
oCMC Project Management & Regulatory Compliance
oDemand Forecasting & Inventory Optimization
oCold Chain Logistics & Import/Export Compliance
oVendor Management & Strategic Sourcing
oGMP, GDP, GCP, and Regulatory Submissions
oLabeling, Packaging, and Serialization Readiness
INDUSTRIAL EXPERIENCE:
Biojiva LLC (Retrotope Inc. was bought by Biojiva LLC) San Jose
Director, Supply Chain and CMC Management 5/22 – 12/24
Retrotope, Inc. (Retrotope filed for Chapter 11 in May2022) Los Altos
Director, Supply Chain Management 8/21 – 5/22
Led CMC activities. Removed drug holidays by implemented Direct to Subject shipments in the clinical distributions. Distributed clinical study materials in US, EU, Australia, Canada, China and Uruguay
Import/Export Compliance: managed all supply chain inventories and movements of goods: clinical and non-clinical
Authored, and maintained forecasts and demand forecasts of raw materials, DS, DP, and clinical study materials
Controlled raw material inventory and specs, ensuring adherence of the manufactured goods against internal specs
Authored CMC budget and tracked accruals
Implemented vendors work orders (RFP) and all relevant docs to initiate project
Collaborate with clinical operations, RA, QA to plan and execute CMC activities to meet clinical studies demands and compliance with global regulations
Collaborate with finance to implement bonds and other logistic requirements for export/import of clinical study materials
Helped to implement work processes by authoring SOPs & work processes. Implement work processes internally & among manufacturing partners & CROs
Author and maintained CMC sections of study protocol, pharmacy manual, and CMC sections of the IND.
Co-author, and updated CMC sections (DP & DS) for regulatory files
Performed vendor selection: DS, DP, and label-pack
Reviewed Batch Records and EBR of DS and DP for technical assessment
Managed DS & DP CMO for development and manufacturing activities
Traceability of supplies & CMOs activities for clinical studies: ensuring accurate information in the CMC regulatory filing
Managed clinical packaging activates: label text development, med-list, secondary packaging, develop batch records, review EBRs, ensured on-time quality release and QP cert
IRT management: user spec development, UAT, and workflow processes
Cold chain logistics: All CMC and clinical supply materials
Risk mitigation strategies: vendor selection, vendor report card via KPIs, and storage location of raw materials and clinical study materials
Drafted and maintained IND timeline
Pliant Therapeutics, Inc. S. San Francisco
Associate Director, Clinical Supply Chain Management 5/20 – 7/21
Head of Supply Chain department: ensured supply of clinical study materials and ancillary for all of Pliant’s clinical studies and non-clinical studies. Worked in cross-functional teams to forecast DS and DP manufacturing for clinical and non-clinical programs, ensuring continuous drug supplies. Distributed clinical study materials in US, EU, Australia, Canada, Taiwan, and Korea.
Managed vendors: couriers, import/export brokers, primary packager, and clinical packaging and labeling
Managed clinical packaging activates: label text development, med-list, secondary packaging, develop batch records, review EBRs, ensured on-time quality release and QP cert
Maintained clinical supply chain activities budget: authored budget, approval of invoices, tracked accruals, and collected approvals on quotes
Traceability of supplies & CMOs activities for clinical studies: ensuring accurate information in the CMC regulatory filing
Comparator drug and ancillary drug sourcing: established documents for QP to release sourced materials as clinical study materials
Partnering with finance to track inventory, and movements of supply chain
IRT management: user spec development, UAT, and workflow processes
Cold chain logistics: All CMC and clinical supply materials
Risk mitigation strategies: vendor selection, vendor report card via KPIs, and storage location of raw materials and clinical study materials
CytomX Therapeutics, Inc. S. San Francisco
Sr. Manager, Supply Chain Management 4/18 – 6/20
Temp Sr. Manager, Clinical Supply Chain Management (Contract, RealStaffing) 3/17 – 4/18
Led the Supply Chain department: ensured adequate inventory supply of clinical study materials, comparator drugs, and ancillary supplies. Worked cross-functionally to forecast DS and DP manufacturing to ensure continuous drug supplies. Successfully labeled and packaged 85 batches of clinical study materials for clinical programs. Distributed in US, EU, Ukraine, Australia, Canada and Korea. Successfully executed risk mitigation strategies for BREXIT without impact to clinical studies.
Vendor management of DP, and clinical packaging
Led packaging of clinical study materails: label text development, med-list, secondary packaging, develop batch records, review EBRs, ensured on-time quality release and QP cert
Maintained inventory of DS, DP, CTM, and comparators
Maintained clinical supply chain activities budget: budget requests to management, annual budgets, approval of invoices, accruals tracking, and collect approvals on quotes
Partnered with finance to track inventory, and movements of supply chain for tariff, and VAT
Managed logistics of DP, and CTM (to depots, and clinical sites), ensuring proper transport documents to meet regulatory filing
Managed IRT: user spec development, UAT, and first line for external and internal user assistance, and, workflow processes
Comparator drug and ancillary drug sourcing: established documents for QP to release sourced materials as clinical study materials
Partnered with CMC, quality and regulatory to ensure proper documents for QP release and expiry update
Authored and implemented SOPs
Reviewed and managed implementation of contracts: quotes, work proposals, RFPs, technical agreements (includes QP agreements), and quality agreements
Traceability of supplies & CMOs activities for clinical studies: ensuring accurate information in the CMC regulatory filing
Performed vendor selection for clinical packager
Cold chain logistics: All CMC and clinical supply materials
Risk mitigation strategies: vendor selection, vendor report card via KPIs, and storage location of raw materials and clinical study materials
Anacor Pharmaceuticals, Inc. (Acquired by Pfizer) Palo Alto, CA
Promoted to Supply Chain Manager (Commercial & Clinical Study Material) 10/14 – 10/16
Promoted to Manager, Drug Development Projects 11/13 – 09/14
Technical Development Coordinator 03/11 – 10/13
Managed the Supply Chain department to ensure successful supply of clinical study materials. Successfully planned operational activities as well as equipment purchases for serialization readiness.
Pharmaceutical Research & Development, CMC
Commercial Supply Chain Responsibilities (Includes New Product Launch Preparation):
Developed and maintained strong internal collaboration with stakeholders, clinical operations, project management, CMC, QA and RA, ensuring high customer satisfaction
Managed vendors & commercial production planning, ensured accurate communication of activities and timely deliverables. Ensured documentations and process for a condensed timeline and readiness
Lowered risk of inventory by proposing and executing risk mitigation plans
Assured accurate inventory by leading process mapping activities and helped to implement ERP system
Represented CMC/Supply Chain in selection and of 3PL to meet corporate goal
Managed and tracked logistics of supply chain
Drafted, and issued forecasts of DS, DP, and long lead time components
Managed commercial supply chain inventory
Worked with finance to provide monthly accruals
Lead & tracked internal, and external activities for compliance of Drug Supply Chain Security Act (DSCSA)
Sourced vendors to support implementation of DSCSA
Helped to develop SOP for DSCSA compliance
Sourced vendors for MRP, manufacturing modules
Risk mitigation strategies: vendor selection, vendor report card via KPIs, and storage location of raw materials and clinical study materials
Clinical Supply Chain Responsibilities:
Managed vendors & commercial production planning, ensured accurate communication of activities and timely deliverables
Developed and maintained strong internal collaboration with stakeholders, clinical operations, project management, CMC, QA and RA, ensuring high customer
Drafted and maintained kitting and labeling activities on MS Project
Ensured timely deliverables by meeting with internal and external stakeholders
Managed CTM: drafted, and issued memos for temperature excursions. Ensured proper storage of CTM. Managed full life cycle of CTM
Managed kitting and labeling of CTM: requested work proposals, drafted label text for regulatory approval, reviewed/edited Master Batch Records and Executed Batch Records, ensured timely closing of deviations.
Pharmaceutical Development Responsibilities:
Developed and tracked timelines for CMC activities: technical transfer, analytical transfer, scale up efforts, ect.
Managed vendors & commercial production planning, ensured accurate communication of activities and timely deliverables
Developed and maintained strong internal collaboration with stakeholders, clinical operations, project management, CMC, QA and RA, ensuring high customer
Managed activities at Drug Product manufacturers CMOs: drafted and maintained NDA & IND timeline and activities, requested work proposal, issued Purchase Orders, coordinated shipments of Drug Product to clinical labeler (CMO)
Reviewed/edited scope of work, proposals and negotiated better prices
Participated in reviewing/edits of Master Batch Records of Drug Product, and Drug Substance
Maintained inventory of DS, DP, excipients, and primary packaging of DP for drug products manufacturing campaigns
Managed and tracked logistics of DS and raw materials: issued regulatory documents for shipments (End-Use letters and pro-forma invoices). Worked closely with CMO to ensure timely delivery of DS (international shipments) and chemical reagents (import into USA and Mexico), worked with broker to finalize shipment documents
Coordinated reviews of bioanalysis and pharmacokinetics reports
Tracking actual(s), monthly accruals, invoices, resolved financial errors, tracked CMC annual budgets ($10 million)
Participating as team member to create CMC annual budgets ($10 million)
Anacor Pharmaceuticals, Inc. Palo Alto, CA
Medicinal Chemist (Research Associate II, Consulting Position) 10/09 – 03/11
(Promoted to Technical Development Coordinator)
Medicinal Chemistry Department
Multistep synthesis, purifications and characterization of small molecules and their intermediates
Helped to maintain lab inventory by ordering resupply of lab supplies & chemicals
ACADEMIC EXPERIENCE:
California State University Hayward, CA
Research Associate (Graduate Thesis, Tethered Deoxypyrimidine Nucleotide) 09/06 – 12/08
Research Associate (Undergraduate project, Boron Analog of Allopurinol) 10/03 – 09/06
Multistep synthesis, purifications and characterization of small molecules and their intermediates
EDUCATION:
University of San Francisco
Advanced Professional Supply Chain Management Certificate
Strategic Best Practices of Supply Chain Management
Tactical Implementation of Supply Chain Management
Functional Perspective of Supply Chain Management
California State University, East Bay
MS Chemistry
BS Biochemistry
AWARDS:
2007-2008 CSU Graduate Student Research Grant
2006-2007 AAAS/Science Programs for Excellence in Science
2005 CSUH Associated Students Scholarship for research activity of boron analogue
2004 Genentech Scholar
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