Actively planned and executed the Manufacturing department's pivotal role in the successful

development of new large-scale commercial labs. Provided technical input to design; conducted weekly status meetings; identified and coordinated equipment ordering within budget constraints; assigned and monitored tasks to scope and timeline. Coordinated cross-functional teams in validation of reusable equipment cleaning program for commercial readiness. Designed status presentations for Directors of QA, QC, Program Management, Manufacturing, Process Development.

Completed scope, timeline update via change control across 5 departments in response to unexpected results. Presented project plan for approval from Director-level stakeholders. Orchestrated internal, external technical teams through process characterization, and risk assessments in drug commercialization for top revenue-producing client under 4M$ contract. Built project documents, tech transfer plans with MS Project, Power Point, Excel, Visio to track up to 10 concurrent client projects ranging from 6 weeks to 2 years. Drove focused client and internal meetings; streamlined follow-up communication by designing templated updates and responses.

Spearheaded a concise 200+ page Project Management training document, elevating team efficiency and knowledge.

Generated comprehensive Manufacturing-related budgets (up to $250K) to support vendor decisions and create platform production offerings. Project Management

Dynamic PMP-certified Project Manager leveraging over a decade of expertise in Upstream and Downstream GMP Manufacturing to orchestrate concurrent million dollar drug development projects. Masterfully navigates complexities of a fast-paced Contract Development and Manufacturing Organization, instilling order through strategic organization and analytical thinking within a functionally-structured environment. Exhibits flexible and adaptable leadership style to foster cross- functional collaboration and drive teams towards achieving shared objectives. PROJECT MANAGER

443-***-**** ad29re@r.postjobfree.com LinkedIn

Kathryn Crowley, PMP

Risk Management Change Control Stakeholder Management Continuous Improvement Quality GMP Communication Process Design Problem solving & Critical Thinking Database Design Tech Transfer Aseptic Technique Cross-functional Collaboration KEY COMPETENCIES

July 2021 to December 2023

May 2017 to July 2021

April 2013 to May 2017

September 2010 to April 2013

Lentigen Technology

PROFESSIONAL EXPERIENCE

Project Manager, Cell and Gene Therapy

Manufacturing Manager (Upstream and Downstream)

Senior Manufacturing Associate (Upstream)

Production Associate (Upstream)

Spearheaded multiple successful Client-owned regulatory filing support for national and international drug submissions (IND, RSF)

Translated Client-needs into contract deliverables aligned with process capabilities and risk. Reviewed those contracts for technical correctness using Jira. Strategized with department heads, technical and quality teams to identify risk and mitigation for designing flow procedures for update to GMP BSL2 lab space, allowing for concurrent process steps, reducing process time.

Designed project KPI databases used to identify continuous improvement. Achieved 40% reduction in shipment document generation time for Yellow Belt certification. Risk Management & Strategy

Proactively addressed late deliverables, including process/testing delays and product-specific issues, mineralizing risk to scope and timeline. Concurrently managed positive relationships with up to 10 clients.

Trusted to projects with up to 100 stakeholders.

Delivered organized, data driven presentations to clients, ensuring understanding of project expectations.

Collaborated with Directors, operators in QA, QC Manufacturing, Program Management to release Clinical material adhering to strict Regulatory (FDA, EU) guidelines. Stakeholder Management & Communication

Established and managed a team of 7 operators in 3 sub-departments (Supply chain, Quality Events, Support), leading to improved organizational efficiency and productivity. Elevated team productivity through cross-training. Greater than 95% large scale GMP run completion without rework.

Designed and led sterile gowning training program, minimalizing test failures. Enhanced team cohesion through team-building activities (e.g scavenger hunts, trivia, surveys presented as polls for get-to-know your colleagues). Advised up to 19 junior staff on goals and provided recognition. Team Management

Introduced sterile welding to GMP process, which reduced handling time and exposure at critical steps.

Increased process efficiency by designing and proceduralizing disposable assemblies, innovative equipment, strategic organization, resulting in ~two-hour reduction in overall processing time.

Authored, edited, and approved hundreds of SOPs through MasterControl ensuring operator consistency and adherence to regulatory guidelines. Served as manufacturing subject matter expert during client audits, providing technical and procedural knowledge to reduce audit findings.

Trained on and integrated SAP software within the Manufacturing Team, allowing quantification of material use and needs, leading to operational efficiency with reduced storage space. Manufacturing & Process Optimization

Bachelor of Science, Major: Biology; Minor: Psychology, Stetson University (Deland, FL) Project Management Professional Certification, Project Management Institute (In good status) Yellow Belt Certification, Miltenyi Biotec

EDUCATION & CERTIFICATION

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