Summary
Overview
Work History
Education
Skills
Timeline
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Kaylie Cyr

San Diego,CA

Summary

Results-oriented Biopharmaceutical Professional with extensive experience in purification processes and a proven track record in deviation investigation. Skilled in leading cross-functional teams, utilizing root cause analysis tools, and implementing effective CAPA to ensure quality and cGMP compliance. Eager to leverage expertise in a QA or Purification Process Development role within the Biopharmaceutical Industry.

Overview

5
5
years of professional experience

Work History

Deviation Investigator - Level 2

Lonza Biologics
10.2022 - Current
  • Technical Writing: Authored clear and concise deviation reports, translating complex scientific findings for a general audience.
  • Time Management: Manage multiple ongoing investigations while adhering to strict deviation closure timelines.
  • Successful closure of 70 unplanned deviations ranging from Minor to Major investigations, achieving 100% on-time closure rate for those within my control.
  • Root Cause Analysis (RCA): Proficiency in various RCA tools (e.g., 5 Why's, 6M, Cause Mapping, Fishbone Diagrams, Pareto Charts) to identify root cause.
  • Data Analysis: Ability to analyze data from various computerized systems (e.g. Syncade (MES), PI Systems, TrackWise, LIMS) to determine root cause, identify trends and support investigation findings.
  • Impact Assessment: Assess potential impact of deviations on product Safety, Identity, Strength, Quality, and Purity (SISQP).
  • CAPA Implementation: Develop and implement effective CAPAs to prevent deviation recurrence.
  • Communication and Collaboration: investigation status updates in Daily Management meetings and presentations to internal and external stakeholders.
  • Meeting Facilitation: Lead deviation meetings (~4x per week), fostering collaboration among internal teams and subject matter experts to reach consensus on investigation paths.

Senior Biotechnician

Lonza Biologics
10.2019 - 10.2022
  • Downstream Processing: Certified in Operation, Training and preparation of all Purification Equipment and Processes including: Chromatography Column Packing, Affinity and Ion Exchange Chromatography, Viral inactivation, Depth Filtration, Viral Filtration, UF/DF, Final Filtration and Internal Buffer System (IBF).
  • Aseptic Technique - Maintained aseptic conditions to ensure product sterility.
  • Equipment Preparation (CIPs/SIPs): Conducted Cleaning-in-Place (CIP) and Steam-in-Place (SIP) procedures for downstream equipment.
  • Use and standardization of Laboratory Equipment: pH/conductivity meters, Cary 60 spectrophotometer SoloVPE spectrophotometer.
  • Adherence / Training / Review of GMP Documentation: Paper and Electronic Batch Records (eBR), Syncade (MES) Workflows and eBR Process Parameters, Work Instructions and Standard Operating Procedures (SOP).
  • Asset Shutdown and Commissioning
  • Extensive Troubleshooting and Quality Event Escalation

Education

Bachelor of Science - Biomedicine

Husson University
Bangor, ME
12.2014

Skills

  • Adherance to Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP)
  • Understanding of Upstream and Downstream Biopharmaceutical Manufacturing Processes
  • Use / Maintenance / Validation of Downstream Production Equipment
  • Data Analysis (PI Processes and Statistica)
  • Use of Computerized Systems (Syncade (MES), Laboratory Information Management Systems (LIMS), Document Management Systems (DMS), DeltaV Plant-wide Control System)

Soft Skills:

  • Meeting Facilitation
  • Communication (Written & Verbal)
  • Problem-Solving and Critical Thinking
  • Teamwork and Collaboration with Cross-Functional Teams
  • Time Management and Organization

Timeline

Deviation Investigator - Level 2

Lonza Biologics
10.2022 - Current

Senior Biotechnician

Lonza Biologics
10.2019 - 10.2022

Bachelor of Science - Biomedicine

Husson University

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Kaylie Cyr