Overview
Work History
Education
Skills
Publications And Patents
Timeline
Generic

Anne Thomas

Kenmore,WA

Overview

23
23
years of professional experience

Work History

Principal Process Engineer

Alpine Immunes Sciences
Seattle, WA
12.2021 - Current
  • Upstream process lead for CMC
  • Managed upstream development, scale up and transfer activities at CDMO
  • Reviewed and approved documentation for GMP readiness, performed Person-in-Plant activities, and presented data to both internal and external partners
  • Collaborated and reviewed experimental designs for commercial process development and process robustness activities
  • Collaborated and participated in process risk assessments
  • Performed in-house cell culture feasibility studies
  • Authored IND sections.

Sr Process Engineer

Elevation Oncology
09.2021 - 11.2021
  • Upstream process lead for CMC
  • Responsible for process transfers and expediated timelines for PPQ readiness
  • Collaborated and guided CDMO on small scale qualification and process characterization studies.

Scientist II

Lundbeck
Bothell, WA
08.2019 - 08.2021
  • Upstream and harvest technical lead for CDMO
  • Managed GMP readiness activities, authored process transfer documents, and reviewed and approved process control strategy and batch records
  • Collaborated with CDMO on protocols and procedures for process characterization studies
  • Monitored process performance and provided updates to internal teams, and authored IND sections.

Sr Process Technology Specialist

AGC Biologics
Bothell, WA
09.2017 - 01.2019
  • Upstream process lead for technology transfers into GMP manufacturing
  • Generated and managed process transfer documents and batch records for process execution
  • Key coordinator between client, process development, supply chain, manufacturing, and Quality Assurance
  • Supported non-conformance (NC) closures
  • Monitored process performance and generated campaign summaries.

Scientist

Amgen
Seattle, WA
11.2003 - 05.2015
  • Upstream harvest lead
  • Developed harvest and primary recovery processes for large scale manufacturing
  • Harvest processes developed included centrifugation, acid precipitation, flocculation and extended microfiltration recovery processes
  • Developed the corresponding clarification trains
  • Developed cell culture media filtration trains, issued development reports and supported large scale manufacturing
  • Upstream and recovery process lead for process transfers into clinical facilities
  • Performed experiments for non-conformances, issued technical reports and campaign summaries.

Development Associate

Lonza Biologics
Portsmouth, NH
03.2001 - 11.2003
  • Conducted process transfers into GMP manufacturing
  • Supported manufacturing operations for both airlift and perfusion cell culture processes
  • Supported harvest recovery processes
  • Identified and qualified critical raw materials, and issued technical reports for both internal and external customers.

Education

M.S. Biochemistry -

University of North Dakota
12.1996

B.S. Biology -

University of Minnesota
01.1991

Skills

  • Process Transfer
  • Over 20 years experience in the biopharmaceutical industry
  • Extensive experience in technology transfers for both fed batch and perfusion processes
  • Extensive experience in both cell culture and harvest development
  • Experienced in cell culture scale-up and scale-down activities
  • Experienced in DoE design and analysis

Publications And Patents

  • Evaluations of Predictive Tools for Cell Culture Clarification Performance, Senczuk, A., Petty, K., Thomas, A., et al., Biotech Bioeng, 113, 3, 568 - 575, 2016
  • PDADMAC Flocculation of Chinese Hamster Ovary Cells: Enabling a Centrifuge-less Harvest Process for Monoclonal Antibodies, McNerney, T., Senczuk, A., Thomas, A., et al., mAbs, 7, 2, 413 - 427, 2015
  • FLOCCULATION METHOD, McNerney T., Petty, K., Thomas, A., Zhao, X., 2013, WO 2013090820A1
  • Maternal Copper Deficiency Differentially Impairs the Developmental Expression of Protein Kinase C Isoforms in Neonatal Rat Brain, Johnson, W.T., Thomas A.C., and Lozano, A.A., Nutr. Res., 3, 113-122, 1999
  • Copper Deprivation Potentiates Oxidative Stress in HL-60 Cell Mitochondria, Johnson, W.T., and Thomas, A.C., P.S.E.B.M., 221, 147-152, 1999
  • Platelet Cytochrome C Oxidase is an Indicator of Copper Status in Rats, Johnson, W.T., Dufault, S.N., and Thomas, A.C., Nutr. Res., 13, 153-1162, 1993

Timeline

Principal Process Engineer

Alpine Immunes Sciences
12.2021 - Current

Sr Process Engineer

Elevation Oncology
09.2021 - 11.2021

Scientist II

Lundbeck
08.2019 - 08.2021

Sr Process Technology Specialist

AGC Biologics
09.2017 - 01.2019

Scientist

Amgen
11.2003 - 05.2015

Development Associate

Lonza Biologics
03.2001 - 11.2003

M.S. Biochemistry -

University of North Dakota

B.S. Biology -

University of Minnesota

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Anne Thomas