Experience

Link Immunotherapeutics
• United States
• Biotechnology
• 1 - 100 Employee
• Director Project Management

  • Jan 2023 - Present


Seagen

• United States
• Biotechnology Research
• 700 & Above Employee

• A.D. Global Technical Development Strategic PMO

  • May 2020 - Dec 2022

  Drove early and late stage ADC and Antibodies through technical development, transfer, scale-up, governance, filing submissions, validation, and commercial launch. Guiding the Global Technical Development/CMC teams risk evaluations and strategies. Drove early and late stage ADC and Antibodies through technical development, transfer, scale-up, governance, filing submissions, validation, and commercial launch. Guiding the Global Technical Development/CMC teams risk evaluations and strategies.



Lundbeck

• Denmark
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Associate Director CMC Project Management

  • Oct 2019 - May 2020

  Alliance management of CDMO and co-led transfer of mAb. Alliance management of CDMO and co-led transfer of mAb.



Alder Biopharmaceuticals Inc. (Nasdaq: ALDR)

• Associate Director, CMC Project Management

  • Jul 2018 - Oct 2019

  Co-led CMC preparations with Regulatory for eptinezumab BLA filing• Worked with CMC cross-functional teams and writing contractors to prioritize Module 3 activities• Organized escalation meetings to achieve senior management decisions

• Sr. CMC Project Manager

  • Jan 2016 - Jun 2018

  • Supported technical transfer of a Phase II product from 1,000L wv CMO to an international Commercial 12,000L wv CMO • Built and led a transfer team to create the first Alder CHO MCB, transfer to a CDMO for development and manufacturing in a newly commissioned single use facility• Participated in the steering/governance committee for Pharmaceutical Operations/CMC for Alder’s first CHO product



Fred Hutch

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Senior Project Manager

  • Feb 2013 - Jan 2016

  Worked with cGMP Cell Therapeutics Facility to manage Phase I & II Clinical Trial projects for CAR T-cell, TCR, Pluripotent Stem Cells, and Gene Therapy. Worked with cGMP Cell Therapeutics Facility to manage Phase I & II Clinical Trial projects for CAR T-cell, TCR, Pluripotent Stem Cells, and Gene Therapy.



CMC Biologics

• Sr. CMC Project Manager

  • 2011 - Jan 2013

  Managed concurrent diverse Phase I – III projects in regulated environments. Gathered, assessed, and interpreted data in both business and scientific settings. Monitored resources, profitability, and areas of risk. Worked with finance on establishing and maintaining customer accounts, invoicing, and revenue recognition. Managed concurrent diverse Phase I – III projects in regulated environments. Gathered, assessed, and interpreted data in both business and scientific settings. Monitored resources, profitability, and areas of risk. Worked with finance on establishing and maintaining customer accounts, invoicing, and revenue recognition.



CMC ICOS Biologics

• CMC Project Manager

  • 2007 - 2010

• CMC Project Manager

  • 2006 - 2007

  Coordinated communication between cross functional teams and clients. Set internal and external meeting agendas; as well as, facilitation of weekly teleconferences with client Project Managers and teams. Established and updated timelines, action and decision logs, and meeting notes.

• Development Associate and Project Manager

  • 2001 - 2006