•Works closely with CMC, Regulatory, Clinical Supply, and Contract Manufacturing Organizations (CMO) to ensure compliance and timeliness of GMP work for small and large molecule programs (Phase I and Phase II).•QA program lead for a large molecule, Antibody-drug Conjugate (ADC) program. Oversight of all manufacturing processes to include Linker Payload, Master Cell Bank, Working Cell Bank, mAb Intermediate (upstream and downstream), Drug Substance (DS) Conjugation, Drug Product (DP), packaging and labeling•Reviews and approves Master Batch Records (BR), Executed BRs, and all ancillary documents required •Final disposition of finished product for clinical use, including country-specific release and collaboration with Qualified Persons (QPs)•Authors and reviews deviations, CAPAs, and change controls•Investigates and completes product complaints•Quality review of analytical documentation including: analytical methods; validation protocols and reports; specifications/Certificate of Analysis (COA); and stability protocols, reports, and expiry extensions•Review and approval of clinical product labels (label proofs and packaging specifications)•Reviews Quality Agreements •Provides quality review for regulatory filing documents (IND and IMPD)•Ensures that GMP work at contract organizations is done in compliance with applicable laws, regulations, guidelines, and SOPs.•Uses Veeva Vault to ensure proper document control

•Quality Assurance (QA) team member that collaborates with internal and external teams to work towards the commercialization of Athersys’ Multistem® cell therapy•Demonstrates a clear understanding of Manufacturing and Quality processes and trained quickly to become an effective document reviewer •Reviews and approves Contract Manufacturing Organization (CMO) Batch Records for Manufacturing (BRM), forms, calculations, cell counts, viability, attachments, and any other documentation provided that pertains to the process•Reviews and approves all QC documents provided by CMO to include QC forms, Certificate of Analysis (COA) from Contract Laboratories for analytical testing performed, and final COA’s for Drug Product and Placebo•Reviews and Approves Certificate of Release (COR) for Drug Product and Placebo for use in clinical trials•Engages with CMO on a daily basis to provide feedback on Good Documentation Practices (GDP) and discrepancies found in documents•Reviews CMO Non-Conformances, Change Requests, BRM template revisions, and all other supporting documentation to facilitate Batch release•Tracks and trends all Non-Conformances related to batches and ensures closure and approval before batch release•Attends Microsoft Teams meetings with internal Quality Assurance and Manufacturing •QA representative at CMO Kaizen event•Uses past expertise of GMP processes to drive change and improve internal processes

•Releases Drug Product lots to be utilized in European clinics for a Clinical Trial treating patients with Amyotrophic Lateral Sclerosis (ALS).•Issuance of all Drug Product Fill documents to Manufacturing department to include; Batch Record, Bill of Material, Labels, Line Clearance, Weight Check, and Equipment Attachments. •Issuance of all Quality Control and Material Control documents associated with Drug Product Fills.•Reviews Drug Product Filling documents to ensure accuracy and completeness of process from start to finish •Reviews Clinical Trial Labels with Medical Numbers to maintain a Double-Blind Controlled Placebo Study for application to final Drug Product Containers.•Generates final shipping labels with Material Control to ensure timely arrival to Clinics for appropriate distribution•Reviews final Drug Product lot packets before sending to Almac Group (company that facilitates Drug Product release to Clinical Trial sites on behalf of Revalesio Corporation)•Leads Quality meetings to investigate non-conformances, utilizing Root Cause Analysis, and assigns Corrective and Preventive Actions (CAPA) to team in response to non-conformances.•Reviews revisions of Batch Records, Standard Operating Procedures, Plans, Stability Protocols, and Reports•Scribe for European GMP audit, contributed by assisting Quality Manager and answered questions asked by Auditor.

•Trained specialist on all clinical release tests including Dissolved Oxygen, Endotoxin, Bioburden, Sterility, Iron Limit Test, Conductivity, pH, and Sodium Chloride Identification•Qualifies incoming raw materials by performing Growth Promotion•Performs monthly Environmental Monitoring by collecting Total Air Particulates and Viable Air samples in the cleanroom•Performs Utility Monitoring including ELIX type II water samples, Total Organic Carbon (TOC) and Conductivity readings•ISO 7 and ISO 5 gown qualified•Participates in aseptic fills using a Robotic Filling System (RFS) in an ISO 7 environment•Monitors Total Air Particulates during aseptic filling process and assists Manufacturing department•Performs complete environmental monitoring in a Restricted Access Barrier System (RABS) to include viable surface monitoring with RODAC plates and ICR swabs•Reviews documents and initiates Document Change Requests (DCRs) when revisions are applicable.•Reports Out of Specifications (OOS) and writes Event Notifications•Participates in Event investigations and contributes to Corrective and Preventative Actions (CAPAs)•Controls laboratory inventory using TopShelf and reorders materials when necessary•Implemented 5S (Sort, Set, Shine, Standardize, Sustain) into the QC laboratory

•Responsible for the aseptic manufacture of Innovax®, a recombinant vaccine administered to chickens to prevent Infectious laryngotracheitis (ILT), Newcastle diseases (ND), and Marek’s disease (MD)•KATA team member. Completed 3-day KATA boot camp. Uses tools and skills learned to continuously improve process. Executes PDCA (Plan, Do, Check, Act) cycles every day to implement changes to lab•KATA challenge was to increase from 3 batches to 4 batches per week, challenge met in May 2015. •Implemented significant process change to current methodology. Reduced cell prep process time by 25% by observing wasted time in process.•Improves scheduling system by designing an auto populated template to reduce time spent doing weekly schedules•Updates and reviews weekly schedule to ensure process flows efficiently•Follows Manufacturing Directions (MD’s) in accordance with GMP•5S member (Sort, Set, Shine, Standardize, Sustain), completed 5-day workshop. Transformed lab by organizing and moving equipment, achieved an ergonomically safe environment. Eliminates wasted motion, restructures lab to ensure the right equipment in the right place•Site Safety Team Member responsible for ensuring department’s monthly audits and safety compliance•Safety Communications member, in-charge of communicating safety awareness to site. Prepares PowerPoint slides for site-wide visuals and ensures strict adherence to safety protocols•Certified Site First Responder•Leads daily production meetings to create transparency within teams•Aseptic Excellence department representative, trains new employees aseptic technique •Uses Kaizen method to increase efficiency and improve ergonomics•Purchases lab equipment through Atlas Portal and IDG Requisition Program•Performs environmental monitoring to include settle plates, rodac touch plates, SAS active air sampling, and air particulate monitoring

•Certified Instructor•Entrusted to aseptically manufacture and assemble clinical human blood derived components in a clean room environment (ISO5, ISO7, and ISO9)•Operates and verifies data in accordance with Good Manufacturing Practices (GMP) ensuring proper weights, measurements and raw materials are associated to correct Batch Records (BR)•High level of experience operating/maintaining equipment including Centrifuges, Biological Safety Cabinets (BSCs), standardized scales, tube sealers, incubators, Fyrite CO2 analyzers, 2D/3D barcode scanners, and Intermec printers•Masterfully operates the Oracle ERP (Enterprise Resource Planning) System, used to capture materials and critical time points during manufacturing processes as well recording and verifying information in printed BRs •Excels when working closely with other Cell Processing Associates using GMP during aseptic processes using Standard Operating Procedures (SOPs) without error•Effortlessly coordinates with other departments such as Scheduling, Materials Management, Quality Control (QC), and Quality Assurance (QA) during patient processing lots•Responsible for receiving apheresis lots associated to specific patient while maintaining a Chain of Identity (COI)•Thrives under time constrained, fast-paced environments including critical, operational troubleshooting•Trained to label and ship Final Product (FP)•Revises documents using First Doc Quality Manufacturing (FDQM)•Reviews Batch Records after production•Oversees gowning and clean room supply stocking

•Responsible for the QC release testing of an Active Cellular Immunotherapy (ACI) in accordance with GMP and processing guidelines in a clinical setting•Experience with a Laboratory Investigation Management System (LIMS) used to capture, enter and generate Laboratory Investigation Reports (LIRs) under decisive time constraints•Trained analyst and data reviewer on all clinical release testing assays including Complete Blood Count (CBC), viability using Trypan Blue Exclusion method, sandwich based ELISA, LAL Endotoxin testing, Manual Leukocyte Differentiation, Flow Cytometry (Staining, Acquisition, and Analysis) using MXP software, and Gram Stain•Knowledge and experience using a BacT Alert system•Highly skilled at troubleshooting assays and assisting in writing Laboratory Investigation Reports (LIRs) and Exception Reports (ERs)•Responsible for maintenance of laboratory equipment including Beckman Coulter AcT 5 diff CP Hematology Analyzer, ELx808 plate readers, centrifuges, Beckman Coulter FC500, and Becton Dickinson FACS Caliber•Oversees inventory management and restocks laboratory reagents and materials •Adept to the handling of human blood under stringent universal protocols•Able to protect patient information and maintain a Chain of Identity•Interview QC bioassay candidates

•Team Lead for manufacturing department and primary coordinator for daily production schedules•Responsible for the manufacture of a human based cellular and tissue product in accordance with GMP and processing guidelines in a commercial setting•Follow production SOPs and Batch Production Records (BPRs) according to industry protocol•Experience in a Class 10,000 clean room with current gown certification•Provide training and leadership to new manufacturing associates•Write process deviation reports and assist in updating department SOPs and BPRs•Consult with outside distributors and internal representatives to improve quality of manufactured product•Interview manufacturing candidates