Clinical Research Organization (CRO) & Biopharmaceutical Services

AJINOMOTO BIO-PHARMA - CDMO (Contract Development Mfg Org.)Drug Product Manufacturing Quality Operations Mgmt Support DURATION: 2018 TO 2021PACIRA PHARMACEUTICALSOperations Management Support HIGHLIGHTS: 1yr. Managed Depocyte aseptic commercial production facility, ensuring facility complied (QA release for use); cleanroom suites (grade A-D) released, all utilities in good status, equipment in functional condition prior to starting production. Scheduled and monitored multiple manufacturing process activities (Bulk, Fill, Pkg operations), working closely with plant personnel to ensure activities were being performed efficiently and in compliance. Provided plant & process issues oversight resolution. Generated deviations, investigation (progress, conclusions) thru Master Control. Performed periodic BR Review & internal systems audits for compliance.MAST THERAPEUTICSQuality Assurance, SC Logistics & Mfg Mgt Support ConsultantHIGHLIGHTS: 1yr 5mo. Provided GxP Operation management support services as a QA, logistics, supply chain (SCM), mfg manager; supporting Mast’s Contract Service Providers (CSPs) – CROs/CMOs, Chemistry, Mfg and Control (CMC), Clinical, Product Development (PD), Quality Control (QC), Regulatory Affairs (RA), and Accounting Depts. Performed suppliers (CSPs) audits, contract re-negotiations and new contract approvals. Performed SCM & Quality process improvements assessments on internal Systems, Manufacturing Operations, Supplier Management Systems and provided recommendations and guidance for proposed improvements.ACADIA PHARMACEUTICALSQuality Assurance, SC Mgt & Mfg Support ConsultantHIGHLIGHTS: 9mo. Provided GxP Operation management support services for Clinical; Quality, Supply Chain (SCM), Mfg & offsite Contract Research/Manufacturing Organizations (CROs, CMOs). Participated in the development and change implementation of the company quality systems and quality agreements in preparation of product approval and commercial launch.

Experience: Cell Therapy OperationsProduction Logistics, Planning, Scheduling; Supply Chain Management and Operations Technical Support. > Responsible for daily supervision and execution of Production Logistics, Planning, and Scheduling activities to support final production master schedules for Commercial and Clinical manufacturing within the Immunotherapy Facility (IMF). > Managed site-operations resolve immediate production technical issues to ensure the execution of production shop floor orders were continued in compliance with cGMP and ERP Master Treatment Schedule. > Responsible for new staff recruitment and training on product change-over, risk management, plant optimization, KPI evaluation and e-system SOPs.> Managed weekly Project Teams in revising & implementing process improvements, escalation and contingency plans.> Monitored, track and report monthly production Key Performance Indicators (KPIs) and metrics.> Responsible for resolving product process deviations and closures with QA to meet lot release and schedule demands prior to shipping.

Experience: Production and Clinical (R&D) Technical Support; Project Management, Production Scheduling, Process Control, Process Improvements, Product Changeover, Analytical Testing and Inventory Management. >Supervised production lab tech personnel managed daily activities in biologic formulations, compounding, QC testing, filling, and packaging of reagents within a fast-pace manufacturing environment.> Responsible for in-process troubleshooting, QC test data analysis, and providing technical decisions and recommendations. > Managed customer complaints responses, product deviations (VR), non-conformances (NCMR), and ensured appropriate correctives and preventive actions (CAPAs) were assigned in collaboration with QA Engineering.>Developed new manufacturing record procedures and Instructions (SOPs) pertaining to new manufacturing product transfers and change control from R&D using the Master Control Electronic Document Management System (eDMS).

Experience: Founder; executive, director, account and project manager roles within Clinica International Corporation. > International Business Development; Managed company in-vitro medical diagnostics product distribution activities for Latin America; budgets, production planning, scheduling, and forecast.> Conducted various international product market research and assessments for the development of new products, Territory Sales Plans, Distribution Strategies, and Product Pricing.> Managed product import and export registration in accordance with International Government Guideline and country of product destination regulations. Provided Customer Technical Support and Training.> Conducted presentations and demonstrations of company product line and medical equipment at yearly Trade Shows.

Experience: Quality Assurance, Global Planning, Logistics Supply Chain Management, Contract ManufacturingPositions held: Sr. Analyst, Sr. Supervisor

Experience: Quality Assurance; Compliance, Validation, Manufacturing Support, Global Planning & Production LogisticsPositions held: Sr. Associate, Supervisor

Experience: Antibody Production; culturing of cells using hollow fiber systems and in-vitro production of monoclonal antibodies, purification of antibodies, ELISA assay testing and inventory control.

Experience: New Product Development Manufacturing, Process Validation, and Contract Manufacturing. > Development of biologics custom calibrators from serum proteins. Manufactured and QC tested diagnostic kit components (calibrators, controls, buffer solutions) and performed RIA/EIA assays, sterile filtration of bulks, sterile liquid filling and freeze drying of proteins by Lyophilization.Position title held: Sr. Production Chemist

Experience: Conjugation, Iodination, Compounding, In-process Test, Antibody Purification, Vivirium> In-vitro antibody production, column chromatography purification. > Tracer production; radio labeling antibodies using iodine 125, solid phase coupling, decontamination of radioactive material. > Compounding, manufacturing and QC testing diagnostic kit components (calibrators, controls, buffer solutions) and performed RIA/EIA assays and sterile filtration of bulks. > Vivarium; general maintenance and veterinary care of rodents, injections and harvested ascites from mice, Sterilization of autocalvable items.Positions title held: Laboratory Assistant, Production Specialist, Production Associate, and Production Chemist

Military Occupational Specialty (MOS): 3043 Supply Administration and Operations, 3044 Purchasing and Contracting