Provide subject matter expertise to study teams for procuring clinical trial equipment, and medical supplies from qualified suppliers in a timely, and accurate manner.

Spearheaded the deliveries of the first patient doses in the US sites. Oversee the logistical and supply chain processes between Achilles and the US clinical sties.Collect the required documentation, staff CVs and SOPs, for the site activation process.Orchestrate the delivery of CAR-T cell therapy to the clinical sites. Maintain the required logistical related documentation for the clinical sites within the Trial Master File, including all patient dosing related documentation.Provide training for portions of the tumor tissue and blood sample collection process to the clinical sites.Liaise with the Manufacturing and Quality teams for the distribution of clinical trial supplies. Generate and approved purchases orders in the Amici finance system.Provide updates in Clinical Project meetings on behalf of the US Patient Supply Operations team.Manage the relationships with the courier vendor services, saving the department $100,000 over the course of 2022.Lead the risk management on behalf of the Patient Supply Operation with the Quality team. Conduct mock shipments to validate shipping routes between Achilles and the US clinical sites.

Exhibiting a solid knowledge of clinical packaging and labeling.Acted as the department manager roll while the manager was unavailable long term.Trained all new full time employees in packaging.Extensive experience working on blistering, carding, and label applicators. Proficient with ORTEMS resource scheduling system, and Rockwell Automation inventory and labeling system.Properly allocate resources with the scheduler to ensure jobs are completed on time.Support Site Quality Operations when corrections or clarification is needed.Lead contact for investigations for Phenix events within Packaging Operations, including implementation of corrective actions (CAPA) and quality document revisions. Provide Packaging Operations expertise to the project management group during technical operations meetings, including packaging designs, flow process, run times and manpower needed.Manage and support full time employee and contract staff.Demonstrated a proficiency in writing and updating Lesson plans, and SOP’s.

Provide supply chain activities for drug substance, drug supply, and bulk drug for Genzyme products in lifecycle management clinical and Research and Development trials by calculating Investigational Medicinal Product, Drug Product, Active Pharmaceutical Ingredient, Clinical Trial Material, and Medical Device needs.Supplied research and development input/forecast to the global Rare Disease sales and operations planning (S&OP) team.Conduct the Rare Disease demand and operations planning (D&OP) meetings with the manufacturing plants to ensure the timely delivery of bulk drug supply to Clinical Supply sites.Managed the international flow of products from Industrial Affairs sites in the US and EU to Clinical Supplies sites in US and EU. This includes managing shipments and documentation in accordance with all local regulations.Authored Quality Technical Agreements (QTA) and Technical Agreements (TA) between Industrial Affairs sites in EU and US and Clinical Supplies sites in EU and US.Contribute to the project planning and operational planning meetings for clinical trials for Genzyme products. Mentor project teammates in the use of the clinical supplies inventory system, and the logistical flow of drug substance and drug product.Manage the logistics flow of clinical trial materials for clinical trials involving Genzyme products.

Provided supply chain activities for Genzyme products in both lifecycle management and research and development clinical trials by calculating Investigational Medicinal Product, Drug Product, Active Pharmaceutical Ingredient, and Medical Device needs.Collected information from partners; specifically, product requirements, timelines, and risks.Created Alignment plan by collecting, analyzing and presenting the project alignment via alignment meetingsSpearheaded the migration of drug product from a decommissioned clinical supply (CS) site to the remaining CS sites, including the batch traceability between inventory systems.Developed Dashboards reflecting allocation rates, confidence level, and margin analysis.

Supervised, mentored, and managed the distribution of workload for the Packaging Instruction group.Ensured the timely production of Clinical Supplies in accordance with Good Manufacturing Practice (GMP) for numerous global projects including: Investigational Medicinal Products (IMP), Master Packaging Records, Batch Production Records, Label Production Records, stability batches, and reports from the inventory system required to accompany the previously listed records.Led global project team that strategized and planned the packaging and delivery of IMP.Managed the stock levels of ancillary and secondary packaging components.Spearheaded a work group for the global harmonization of GMP documentation within the Clinical Supplies department.Tracked Key Performance Indicators for the Clinical Supplies group regarding GMP documentation.Authored Global Standard Operating Procedures for use in the Clinical Supplies Department.Mentored and trained Clinical Supplies group on the GMP documentation and the inventory system.

• Presented proprietary communications solutions to varying sized businesses.• Oversaw cabling projects, providing internet and Voice Over IP telephony to two buildings.• Managed and implemented sales and marketing strategies for sales force.

• Provided mortgage and title research.

• Provided wireless network consulting to small (1-10 seats) offices.

• Presented solutions to Executive levels in the Fortune 500 companies, using Power Point.• Provided Risk Management and Crime Prevention services to Fortune 500 companies.• Generated additional opportunities within existing clients,• Prepared sales performance and market penetration reports for the executive team.

• Developed IT business plans specifically tailored for small to medium sized business clients, by working with the clients in a consultative capacity.• Prospected for new business in existing and new accounts, via referrals, and cold calling.

• Promoted three times starting in the warehouse and exiting from the Business Sales Department• Participated in various retail and corporate computer sales roles.