Manage the receipt, inspection, and documentation of incoming materials, including active pharmaceutical ingredients (APIs), excipients, packaging materials, and laboratory supplies
Oversee the proper storage and handling of materials in accordance with Good Manufacturing Practices (GMP) and other regulatory requirements
Lead inventory management activities, including cycle counts, reconciliations, and disposition of expired or obsolete materials
Collaborate with cross-functional teams, including finance, procurement, quality assurance, and production, to ensure timely availability of materials for manufacturing schedules
Utilize electronic inventory management system D365 to track material movements, maintain accurate inventory records, and generate reports as needed
Train and mentor junior material technicians on proper handling procedures, safety protocols, and regulatory compliance
Identify opportunities for process improvements and efficiency enhancements within the materials management function
Participate in internal and external audits, providing documentation and support as required
Establish protocols, policy, and standard operations procedures
Serve as a subject matter expert on material handling best practices and regulatory guidelines.
Senior Material Technician (Contractor)
Kelly Services/ Merck
06.2022 - 02.2023
Perform day to day activities of Material Technicians 1 and 2
Dispense, weigh, and subdivide OEB 1 and 2 raw materials and excipients for drug product manufacturing for pilot plant manufacturing operations, sampling, and analysis of incoming goods in support of quality certification, document retain samples in inventory management
Use SAP along with working knowledge of manufacturing procedures and federal regulations pertaining to manufacturing processes
Employ detailed knowledge of good manufacturing systems in accordance with regulatory and manufacturing SOPs and cGMPs
Plan, organize, and manage the execution of team member task.
Logistics Management Specialist CAR-T
Novartis Cell and Gene Therapies Unit
11.2018 - 04.2022
Perform goods receipt for incoming Apheresis and final packs for outgoing patient delivery
Inspect and verify material, labels and documents for accuracy
Follow SOPs to ensure quality from start to finish applying lean initiatives
Provide on the floor training and reinforce lean principles
Lead teams to assure inventory accuracy supporting CAR-T and warehouse functions
Load and unload trucks verifying paperwork for accuracy of raw materials received
Stage materials created goods receipt and transfer to their proper locations
Coordinate shipping, receiving, storage and processing of goods for imports/exports
Proficient in various operating systems, including but not limited to SAP MES & LIMS
Use MES for labeling scanning and storage for Apheresis and harvest blood
Responsible for scheduling preventive maintenance staff to perform monthly calibration of cold storage and LN2 tanks
Schedule pickup and destruction of both Non-hazardous and hazardous waste
Prepare scrap form with dollar amount for finance and monthly KPIs.
Lead Supply Chain CAR-T (Contractor)
Joule Staffing/Celgene
01.2018 - 11.2018
Complete inventory and material transfer within warehouse facility
Perform inspection and Goods receipt of incoming raw materials, Leukapheresis, PBMC, and components in collaboration with quality assurance
Manage material expiry, lot, and batch control pertaining to COA and final documentation
Prepare dry shipper and final drug product for carriers deliver to customers
Support CAR-T manufacturing operations and dispose manufacturing hazardous waste.
Pharmaceutical Development Technician R&D
Bristol-Myers Squibb Company
04.2016 - 12.2017
Oversee and discuss batch records, setup and safety precautions in cGmp environment
Perform Delta-V interface recipe and SAP for scanning raw materials to reactor process
Maintain documentation through Delta-V with laboratory inventory management systems
Paid attention to detail of activities such as distillations, reactions, filtrations, extractions, and sampling
Set-up pumps, meters, centrifuges, hoses, and tank farm transfers for processing
Lock out equipment and write work permits for maintenance
Unload raw materials, review BOL, COA, and scan material into the proper location within the warehouse
Prepare paperwork and perform proper shipping for final drug product.
Chemical Operator/Esters
Stepan Company
09.2014 - 01.2016
Job responsibilities in harsh weather operating heavy equipment, rail cars and tank trucks
Execute batch making procedures following cGMP guidelines to produce quality finish products
Scan and retrieve raw materials from location for batch processing
Sample product from reactors to check specs to be drummed, load tank trucks and railcars for shipment
Check P-notes for daily responsibilities and tank truck log for incoming raw materials
Gauge tanks for levels, temperature, and document readings on a weekly basis
Write work permits for maintenance and use mechanical lifts to LOTO piping and valves
Use SAP to document data, check reactor schedule and complete batch paperwork.
Pump House Operator (Contractor)
Manpower Staffing/Exxon Mobil
01.2014 - 06.2014
Perform duties in extreme weather operating equipment, handling hazardous materials and tools
Perform DOT inspections when loading and unloading tank trucks or railcars
Sample raw material and finish product following sample protocol and SOP’s
Run test for IR, specific gravity, viscosity, and acidity
Use PPE for specific handling of raw material including full face respirator
Check paperwork for certificate of analysis, P.O
Numbers, carrier seals match bill of lading
Gauge tanks for weekly inventory and LOTO equipment for maintenance work orders.
Education
High School Diploma -
Irvington High School
Irvington, NJ
05.1989
Skills
10 years of experience in materials management or logistics within the pharmaceutical industry, with a demonstrated progression of responsibilities
Thorough understanding of GMP, FDA regulations, and other relevant quality standards
Licensed Forklift, Genie Boom and Scissor Lift
Creative problem-solving capabilities and leadership experience
Excellent verbal and written communication skills
Proficient in Microsoft Teams, Word, Excel, PowerPoint and Outlook