Katy Crowley Email and Phone Number
Cell & Gene Therapy | Lab startup | CMC | Process Characterization | Project Management | Change Control | Tech Transfer | Continuous Improvement | Quality System | Validation, IOPQ at
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BrainChild Bio
Katy Crowley's Location
Federal Way, Washington, United States, United States
About Katy Crowley
I am passionate about making strides in the fight against cancer – because #CancerSucks! Currently, I am excited and fueled in my newest role as Senior Project Manager. I strive to establish a symbiotic relationship where I add value to the program, but also leverage my curiosity and drive to acquire new skills. My background includes serving as a certified Project Manager in a Contract Development and Manufacturing Organization (CDMO) environment supporting client drug development programs, and amassing over a decade of experience focused on GMP and lentiviral manufacturing and process development.My journey at Lentigen began as the 18th employee and first GMP operator and has allowed me to manage multiple concurrent client drug development initiatives, from pre-clinical to clinical (phase 1 to 3) and commercial stages. My mission is to deliver high-quality and timely results that meet or exceed client and company expectations and regulatory standards while optimizing operational efficiency and collaboration across cross-functional teams.I have successfully orchestrated several projects collectively valued over $4M, including a cell therapy program for a top revenue-generating client in commercial readiness, for which I devised and maintained a project plan for the process characterization risk assessment stage. I have also enhanced internal workflows and communication within project management, and supported the tech transfer of processes from development to manufacturing. Additionally, I have a strong background in GMP manufacturing and lab startup, having led and trained teams of up to 19 personnel in upstream, downstream, and support processes for GMP lentiviral production.Superpowers: Instilling order from chaos through strategic organization and process streamlining Developing new procedures and optimizing current ones through data-driven decisions Fostering collaboration across diverse departments and hierarchy levels Commitment to completing tasks thoroughly, punctually, and with a positive attitude Expert in pre-clinical to commercial GMP manufacturing, and drug development projects Incorporating shark facts into conversations and utilizing the color purpleAsk me about: Starting as the first GMP employee at Lentigen Technology My department and team development philosophy My voluntourism expeditions to the Bahamas and Galapagos Anything sharks or the latest integration of purple into my life
Katy Crowley's Current Company Details
Brainchild Bio
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Cell & Gene Therapy | Lab startup | CMC | Process Characterization | Project Management | Change Control | Tech Transfer | Continuous Improvement | Quality System | Validation, IOPQ
Katy Crowley Work Experience Details
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Senior Project ManagerBrainchild Bio Jun 2024 - Present
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Project ManagerLentigen Technology, Inc Jul 2021 - Dec 2023Gaithersburg, Maryland, United StatesOrchestrated cross-functional teams to manage multiple concurrent client drug development initiatives, collectively valued over $4M, while overseeing operational aspects from pre-clinical to clinical phases (1 to 3), resulting in commercial readiness.Sustained continuity of top revenue-generating client's $4M cell therapy program as Interim Commercial CMC PM. Devised and executed a comprehensive project plan for the process characterization risk assessment stage.Optimized cross-functional tech transfer communication, and internal workflows within project management, enhancing operational efficiency and facilitating smoother project execution and consistency. Proactively identified and addressed challenges/risks to project scope, implementing solutions. In response to unexpected results and newly acquired information, spearheaded development and execution of a revised project plan to validate the equipment cleaning program ahead of FDA PAI inspection, mitigating likelihood of inspection findings.Liaison to clients for Regulatory support and time sensitive agency (JP, FDA, EU) responses. Coordinated internal tasks to gather requisite information for IND and RSF filings.Utilized MS Project, Power Point, Excel, and Visio to create project documents. Led focused internal/external meetings, managed follow-up Translated business strategy into project plans with objectives, and resource assignment. Ensured contract deliverables and project plans were shared/understood cross functionally to achieve On Time/In Full deliveryArranged time-sensitive domestic/international shipments of temperature-regulated biological material Identified areas of opportunity for continuous improvementCollaborated with department heads and individual contributors to conduct technically-driven discussions for informed decision makingHarmonized collaborative efforts among internal departments and external stakeholders to ensure the punctual release of clinical lentiviral material
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Manufacturing ManagerLentigen Technology, Inc. May 2017 - Jul 2021Gaithersburg MdLeadership and Team Management:Led a team of up to 19 personnel in the manufacturing of clinical material within a fast-paced CMDO environment.Scheduled and assigned tasks for both upstream and downstream personnel, optimizing workflow efficiency.Ensured completion of training for both myself and junior personnel, fostering a skilled and knowledgeable workforce.Made critical on-the-floor manufacturing process decisions aligned with acceptable process risk, demonstrating problem-solving skills.Participated in external vendor audit to ensure raw material safety and compliance. Project Planning and Coordination:Developed project plans, calendars, and task assignments to effectively manage projects related to GMP lentiviral manufacturingConducted team and project meetings, creating detailed meeting minutes and maintaining accurate action item updates.Coordinated with QA and QC to ensure manufacturing and results compliance with agency (FDA, EU, JP) regulations, maintaining high-quality standards throughout production processes.Developed and managed budgets, collaborating with vendors to procure high-quality goods and services while adhering to financial constraints. Implemented reusable sterile gowning for GMP Manufacturing, significantly reducing overall material costs and minimizing environmental footprint.Process Improvement and Documentation:Authored and/or approved SOPs, BPRs, SMPs for the Manufacturing dept, ensuring adherence to regulatory standards and best practices.Drove process optimization and quality improvement initiatives through the development risk assessments, change controls, investigations and CAPAs.Utilized basic knowledge in downstream processes including SEC and clarification, contributing to process optimization and efficiency.Maintained custom material inventory through effective vendor communication, ensuring seamless supply chain management. -
Senior Associate Manufacturing, UpstreamLentigen Technology, Inc. Apr 2013 - May 2017Gaithersburg, MdLeadership and Management:Led a small team to successfully execute multiple projects in a dynamic and fast-paced environment.Created and maintained meticulous records of daily tasks and project performance via databases and project documents (Issue log, lessons learned).Designed and implemented a comprehensive training program to onboard and upskill new and existing employees, building a knowledgeable and skilled teamTechnical Expertise and Experimentation:Conducted experiments for upstream process development and optimization for Lentiviral production, contributing to process efficiency.Received cross-training in downstream processes including TFF, SEC, and clarification techniques, enhancing versatility and knowledge base.Demonstrated expertise in maintaining sterile mammalian cell cultures with aseptic technique, ensuring product integrity.Upstream SME for internal projects and external auditsDocumentation and Compliance:Authored and revised SOPs, BRs, and SMPs for GMP lab operations, ensuring compliance with regulatory standards and consistency between operators.Coordinated with QA and QC teams to ensure GMP compliance with clinical and pre-clinical material production, maintaining high-quality standards.Project Coordination and Organization:Organized current and future projects through calendars, charts, and lists to meet deadlines, facilitating efficient project management.Generated project reports, analyzed data, and presented findings to upper management for strategic decision-making.Coordinated the adaptation of large-scale (200L) suspension processes for GMP Lentiviral production in a BSL2 lab, increasing revenue options and capacity
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Production AssociateLentigen Technology, Inc. Sep 2010 - Apr 2013Gaithersburg, MdProject Management and Leadership:Led a team in completion of multiple projects within diverse and fast-paced environment.Developed and adapted large-scale processes for GMP Lentiviral production.Designed and implemented run logs for comprehensive data capture, supporting KPI implementation and historical graphic creation.Created and presented project reports, analyzing data for strategic decision-making by upper management.Established and executed training programs for new and existing employees, ensuring proficiency in procedure.Technical Expertise and Experimentation:Designed and executed experiments to optimize upstream processes, contributing to process development and efficiency improvements.Conducted cross-training in downstream processes, including TFF, SEC, and clarification techniques.Maintained sterile mammalian cell cultures with aseptic technique in suspension and adherent Cell Culture vessels to ensure product integrity.Authored and revised SOPs, BPRs, SMPs, and experimental protocols for GMP lab operations and R&D/PD initiatives.Quality Assurance and Compliance:Coordinated with QA/QC teams to ensure compliance in GMP ManufacturingCollaborated with vendors to maintain equipment calibrations and conduct routine maintenance.Safety Committee Volunteer, actively contributing to a culture of safety and compliance within the organization.General Lab Operations:Performed routine maintenance on lab equipment to uphold operational efficiency and accuracy.Maintained an organized lab environment through task assignment, cleaning schedules, and inventory management.Generated project budgets, optimizing resource allocation for efficient project execution.Conducted transfections for the production of Lentiviral Vectors, contributing to the manufacturing process.
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Laboratory TechnicianKelly Government Solutions Mar 2009 - Sep 2010Bethesda MdKelly Government Solutions, Rockville, MD for National Institutes of Health –National Institute of Allergies and Infectious Diseases (NIAID), Bethesda, MD Laboratory Technician, Contract Position, March 2009 –Sept 2010NIAID conducts and supports research to better understand, treat, and prevent infectious, immunologic, and allergic diseases. Main project aimed to develop new drugs that shorten the time necessary to complete effective Tuberculosis therapy.• Contributed to reducing assay runs from 2 weeks to 5 days through troubleshooting, streamlining and process regulation • Followed rules and regulations and gowning requirements for BSL3 • Maintained sterile tuberculosis cultures• Often sought out by other lab researchers to assist on their personal and acquired projects • Acquired operational skill in running and troubleshooting Beckman Coulter Biomek FX (Automated Liquid Handler) and related software, as well as Elmer EnVision multi-label plate reader • Obtained basic security clearanceResponsibilities: Assist in the development and validation of high-throughput screening assays and cell viability assays to monitor viability and metabolic status of Mycobacterium tuberculosis under a variety of conditions; Maintain a functional lab through regular inventory, creating schedules for cleaning and maintenance, coordinating projects with coworkers; Perform MICs on compound libraries; Work with minimal supervision.
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Pilot Plant Technician I, Ii, IiiMedimmune Sep 2005 - May 2009Gaithersburg MdMedimmune, Subsidiary of AstraZeneca Gaithersburg, MD Pilot Plant Technician I, II, III (May 2006- March 2009)[Started as a Temp through Kaztronix, McLean, VA Contract Laboratory Technician, Sept 2005-May 2006] Medimmune is a worldwide supplier dedicated to research and manufacturing of products designed to prevent infectious diseases, cancer and inflammatory diseases. Their four major products Synagis®, Ethyol , FluMist, and CytoGam.GMP Projects: MAb production for drug therapies to treat autoimmune diseases and cancers in phases I, II and III clinical trials; Cell-based Seasonal and Pandemic Flu Vaccine Process Development • Trouble shooting experience with ABEC, B. Braun, Apllikon bioreactors in a BSL2 GMP lab• Received small-scale tech transfer information and applied it to 600L scale.• Coordinated group responsibilities by creating and implementing process schedules, and delegating duties• Key member in new GMP lab start-up: Adapted small-scale cell culture-based viral vaccine production to 10L bioreactor scale, leading into 600L production • Performed viral inoculations and harvests involving microcarriers• Able to perform SIP, CIP, pressure tests, basic PM on manual and automatic large scale bioreactors• Used aseptic technique to maintain sterile cultures of mammalian cells in flasks, cell factories, and 25 to 600L bioreactors with fed-batch processes• Volunteer Area Training coordinator: Set up site-specific training regimens; Trained new and existing employees• Designed disposable assemblies, with vendor collaboration, to use for process adaptionPast Responsibilities: Create and Implement inventory schedule; Record data and present it to management, along with any process issues and solutions; Validate new and existing equipment; Working knowledge of programs - EDMS, DeltaV, TrackWise, Visio; Maintain lab equipment; Write and revise SOPs and batch records; Perform prospective employee interviews; Volunteer Safety Representative/CPR Respondent -
Laboratory TechnicianIgene Biotechnology Inc Jun 2004 - Sep 2005Igene develops, produces and markets specialty ingredients for human and animal nutrients and is the number one supplier of Astaxanthin, a nutrient and pigment for salmon and trout species. Used aseptic technique to adjust multiple parameters for fermentation experiments with minimal supervisionManaged scheduling and responsibilities for 2 other employeesRecorded and analyzed data and presented it to managementTrained new employeePast Responsibilities: Execute regular sample schedule of 10L and 25L fermentors, make adjustments to nutrients as required; Inoculate and harvest yeast cell cultures; Organize lab by creating and executing cleaning, inventory, equipment maintenance and shift schedules; Perform inventory and order supplies; Prepare media and chemical solutions; Maintain and perform PMs on lab equipment including, microscope, Y.S.I. 2700, and Spectronic 20 and Genesis 5
Katy Crowley Education Details
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Bachelor'S Degree
Frequently Asked Questions about Katy Crowley
What company does Katy Crowley work for?
Katy Crowley works for Brainchild Bio
What is Katy Crowley's role at the current company?
Katy Crowley's current role is Cell & Gene Therapy | Lab startup | CMC | Process Characterization | Project Management | Change Control | Tech Transfer | Continuous Improvement | Quality System | Validation, IOPQ.
What schools did Katy Crowley attend?
Katy Crowley attended Stetson University.
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Ambitious Social Worker, Passionate About Social Justice, Equity, And Inclusion. ||"I Am A Lifehouse Rather Than A Lifeboat. I Do Not Rescue, But Instead Help Others Find Their Way To Shore."West Des Moines, Ia
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