Francesca McNeill
Coats,NC
Summary
Accomplished in elevating manufacturing operations at FUJIFILM Diosynth Biotechnologies through strategic automation integration and robust problem-solving, I excel in technical documentation and team leadership. Leveraging expertise in 5S Principles and fostering collaboration, my contributions have significantly shaped operational efficiencies and compliance, underpinning sustainable growth and quality improvement.
Overview
6
6
years of professional experience
Work History
Manufacturing Support Associate II
FUJIFILM Diosynth Biotechnologies
03.2024 - Current
- Increased support quality with thorough troubleshooting and problem-solving techniques.
- Contributed to strategic planning initiatives, helping to shape the future direction of the company''s manufacturing operations.
- Increased output with the introduction of advanced automation technologies in manufacturing operations.
- Ensured compliance with all relevant safety regulations during all stages of product development and manufacturing operations.
- Developed training materials for production staff, ensuring consistent implementation of best practices across all shifts and facilities involved in manufacturing operations.
- Demonstrated adaptability by quickly learning new processes, technologies, and software applications relevant to composite manufacturing operations.
- Consistently met or exceeded performance metrics, showcasing dedication to providing exceptional support services.
- Balanced multiple tasks simultaneously, maintaining focus on delivering optimal outcomes for each client interaction.
- Developed long-term strategies for manufacturing operations, aligning with company goals and objectives to drive sustainable growth.
- Streamlined manufacturing operations by developing and implementing standard operating procedures.
- Performed manufacturing support activities related to drug product and finished goods to ensure compliant and reliable production
- During the project phase, lead operational readiness initiatives as well as site commissioning and qualification efforts
- Supported and participated troubleshooting for respective process area
- Performed documentation updates to support reliable production
- Created non-batch activities and associated documentation for tech transfer, changeover, preventive maintenance plans (PMs), column packing
- Supported change management records, investigations, corrective and preventive actions (CAPAs) and continuous improvement (CI) activities to supports manufacturing
- Supported Inspections and audits by providing requested manufacturing documents
- Performed manufacturing support activities related to drug product and finished goods to ensure compliant and reliable production
Technical Lead, Operations
Pfizer
01.2024 - 03.2024
- Performed manufacturing activities per current Good Manufacturing Practices (cGMPs).
- Performed all aspects of biologic's upstream and downstream production.
- Operated production equipment safely in accordance with established standard operating procedures.
- Conducted activities in support of production schedules as directed by leadership.
- Managed multiple projects simultaneously.
- Reviewed SOPs, master batch records, specifications, and other applicable cGMP documentation for Manufacturing.
- Maintained GMP records to comply with regulatory requirements and assist with in-process testing.
- Ensured compliance to training on an activity prior to GMP execution.
- Reviewed completed batch records daily for GMP compliance and completeness.
- Inventory manufacturing supplies and ensured items were properly stocked.
- Operated to the highest ethical and moral standards.
- Adhered to quality standards set by regulations and policies, procedures, and mission.
- Worked effectively in a team environment
- Provided clear enhanced communication between departments by establishing a collaborative environment that fostered teamwork and innovation.
- Provided hands-on support during peak periods, contributing to overall team success in meeting tight deadlines.
- Managed daily operations, ensuring timely completion of work orders and maintaining high safety standards in the workplace.
- Increased team productivity by setting clear expectations, providing regular feedback, and conducting performance evaluations.
- Mentored junior team members for professional development, enhancing overall skill set within the group.
- Assisted senior management with strategic planning efforts by providing valuable insights from the production floor perspective.
- Evaluated existing workflows, identifying opportunities for improvement and implementing changes as needed for increased efficiency.
- Communicated job expectations and monitored employees.
Technical Operations III
Pfizer
12.2020 - 12.2024
- Offered assistance in implementing and developing training programs.
- Collaborated with vendors to locate replacement components and resolve advanced problems.
- Responsible for cGMP production of phase I/II clinical drug substance supporting the Pfizer Bio-therapeutics portfolio.
- Focused in the area of mammalian cell culture startup to prepare the facility for operational readiness. Standard Operating Procedures, reviewing batch records, and standard work.
- Supported commissioning and qualification of process equipment. Execution of microbial upstream processes.
- Provided a good understanding of procedures, techniques, tools, materials and equipment.
- Demonstrated the ability to prioritize workflows based on the available resources. Follow standard procedures to complete tasks, some of which may vary in scope, sequence, complexity and timing.
- Simultaneously ran to two separate processes; different campaigns in separate operating suites
- Experience in hypothesis driven laboratory work with skills in cell culture, cell transfection by introduction of targeted virus into biological processes
Research and Development Process Associate
Pfizer
12.2018 - 12.2020
- Production of vectors for gene therapy products using AAV model system in HEK293 cells. Engaged in pilot scale laboratory experience that process utilities, media preparation and bioreactor operation.
- Responsible for include set up, execution, and evaluation of non-GMP unit operations such as bioreactors, executing aseptic sampling, parts washing, solution preparation, inventory management, documentation, work order generation, and data entry/evaluation
- Aseptic technique, cell counting, culturing mammalian cell lines in shake flasks and/or bioreactors, thawing and freezing cell lines, and determination of cell culture metabolites
- Experienced in laboratory instrumentation such as pH meter, microscope, incubator, balances, pipetting, bioreactors, wave reactors.
- Experienced in laboratory information management systems LIMS, SAP, Simplica and Axis 360, · electronic laboratory notebook (ELN) to document and record media preparation and instruments and equipment being used per experiment.
- Expressed the ability to prioritize and organize workload to efficiently accomplish departmental goals. Utilized aids and SOPs to make decisions about the proper production path per product.
Education
Bachelor of Science - Industrial Tech. Minor Bioprocess Manufacturing
East Carolina University
Greenville, NC05.2025
Associate of Applied Science - Biopharmaceutical Technology
Wake Technical Community College
Raleigh, NC05.2019
Skills
- 5S Principles
- Technical Documentation
- Team Leadership
- Master Control Building of EBRs
- Sample Management
- Axis 360
- Correction Action Planning
- Quality Improvement
- LabWare LIMS
- Software: Microsoft Excel, Smartsheet, Kneat, Tulip, ELN, Syncade, CEBA
- Sound Decision-Making Abilities
- Problem-Solving Skills and Collaboration Skills
Timeline
Manufacturing Support Associate II
FUJIFILM Diosynth Biotechnologies
03.2024 - Current
Technical Lead, Operations
Pfizer
01.2024 - 03.2024
Technical Operations III
Pfizer
12.2020 - 12.2024
Research and Development Process Associate
Pfizer
12.2018 - 12.2020
Bachelor of Science - Industrial Tech. Minor Bioprocess Manufacturing
East Carolina University
Associate of Applied Science - Biopharmaceutical Technology
Wake Technical Community College
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