Open To Work
Laura P White
Woodinville,WA
Summary
Compliance manager with extensive experience in managing programs and resources to fulfill customer requirements. Demonstrates flexibility and adaptability, coupled with exceptional communication and relationship management skills. Proven track record in identifying issues, gathering data, and formulating solutions.
Overview
12
12
years of professional experience
Work History
P&PD Compliance Manager
Just-Evotec Biologics
Seattle, Washington
01.2024 - Current
- Developed phase-appropriate quality compliance program for process and product development.
- Coordinated global strategy across three sites to harmonize ICH, FDA, and EMA guidelines.
- Implemented data integrity practices to ensure qualified systems generated accurate data.
- Facilitated training program to align corporate and local training requirements with scientific expertise.
- Reviewed client audit requests and coached SMEs for comprehensive audit responses.
Supervisor
Cepheid
Bothell, Washington
01.2021 - 01.2023
- Supervised enzyme manufacturing teams in upstream, formulation, quality control, and production services.
- Managed budget resources and scheduling to align with production planning and objectives.
- Coordinated site production schedule across three manufacturing lines for efficient order flow.
- Facilitated cross-training program with enzyme and cross-functional teams to ensure resource availability and avoid resource reductions.
- Represented production and quality control teams for MRB, utilizing SmartSolve for investigations.
- Collaborated with R&D and SMEs to expedite timelines for deviations and laboratory failure investigations.
- Directed manufacturing changes to meet compliance requirements for WHO audit in Q4 2022.
Scientist-Manager
Systimmune
Redmond, Washington
01.2018 - 01.2020
- Led upstream and cell line development teams to achieve performance objectives and meet project deadlines.
- Developed cell lines for bispecific antibodies, multi-specific antibodies, and ADC molecules while implementing stability testing programs for MCB and WCB.
- Designed upstream processes using Eppendorf DASGIP system with 3L and 15L reactors in a 16-slot format.
- Coordinated project schedules to align with aggressive timelines and development goals.
Research Scientist III
Seattle Children’s Research Institute
Seattle, Washington
01.2014 - 01.2018
- Manufactured CAR T-cell products in cleanroom under GMP standards for Phase I and II immunotherapy trials.
- Interacted with patients, families, nursing staff, and doctors during infusion procedures.
- Represented SCH for Seattle's KING5 and UK television documentary.
- Designed training program for new hires in compliance with GMP standards and CFR guidelines.
- Standardized methodologies, reducing average training completion time by up to 70%.
Education
Bachelor of Science - Microbiology, Biochemistry
Montana State University
Bozeman, MTSkills
- Veeva, Agile, and ComplianceQuest
- ComplianceWire and MasterControl
- SmartSolve and LIMS
- Electronic lab notebooks (ELN)
- SAP S/4HANA
- Six Sigma and Lean principles
- Risk management strategies
- Root Cause Analysis
- SCADA systems expertise
- Blue Mountain RAM
Languages
French
Limited
Work Preference
Job Search Status
Open to workWork Type
Full TimeLocation Preference
On-SiteRemoteHybridSalary Range
$140000/yr - $200000/yrTimeline
P&PD Compliance Manager
Just-Evotec Biologics
01.2024 - Current
Supervisor
Cepheid
01.2021 - 01.2023
Scientist-Manager
Systimmune
01.2018 - 01.2020
Research Scientist III
Seattle Children’s Research Institute
01.2014 - 01.2018
Bachelor of Science - Microbiology, Biochemistry
Montana State University