Michelle Beck - Palomar College

ABIGAIL W. MEYER, page 2
Regulatory Affairs, One2One (September 2006 to April 2007)
Managed customer projects and packaging changes for drug submissions while interfacing with FDA
• Submitted two bundled supplement, fast-track CDER/CBER applications affecting over 88 approved
applications with no deficiencies through an internal cross-functional team consisting of all major development
functions.
• Developed, created, and submitted multiple new drug applications and supplements to existing applications as
well as Drug Master Files for One2One customers.
• Created and provided guidance for regulatory decisions and documentation of post-approval material changes
to existing primary and secondary container components.
BAXTER BIOPHARMA SOLUTIONS, Bloomington, IN October 2001 to August 2006
Quality Associate III (January 2005 to August 2006)
Initiated continuous improvement processes in Quality and Operations
• Lead Lean events in Operations and Quality improving manufacturing batch record processing flow and
resulting in a cycle time reduction from 18 to 4 days.
• Managed DMAIC Green Belt project in Quality Control Chemistry Lab resulting in a cycle time reduction of
30% and a standard deviation reduction by 50%.
Senior Project Coordinator (August 2003 to August 2006)
Managed timelines and deliverables for 25 client specific projects totaling more than 40 different parenteral products
• Developed, reviewed and approved Manufacturing Batch Records, Clinical and Commercial Supply
Agreements, Contractual Quality Agreements, and Process Validation Summaries.
• Created, initiated and maintained stability programs for client specific products; from project plan pricing &
negotiation to development through end stage regulatory submissions.
• Developed streamlined documentation for result reporting for all QC Lab results cutting documentation
rework time.
Quality Associate II, QC Training Coordinator (August 2002 to August 2003)
Developed Training Coordinator position and job description
Quality Associate I, QC Analyst (October 2001 to August 2002)
Performed drug commercial release and stability testing for over 60 products
EDUCATION
College of Arts and Sciences, Indiana University, Bloomington, IN
Bachelor’s degree in Biology with Concentrations in Psychology and Animal Behavior, August 2001
Kellogg School of Management, Northwestern University, Evanston, IL
Executive MBA, June 2013 (expected)
HONORS
Honorary Sponsor - House of Representatives Bill (H.R. 1553), Extension of Assassinations Records Review
Board, Washington, D.C. (1998)
SKILLS
Process Innovation Strategic Sourcing CFR, ISO, GMP, GDP knowledge
Drug Stability Value Stream Mapping Minitab® application
PMBOK Training Lean Manufacturing Pharmacopoeial knowledge
Outcome Driven Innovation Practitioner US CTD Regulatory guidance
Lead Investigator & Technical Problem Solving Microsoft Applications