Briefly
About Me

I am a biotechnology, life sciences, and healthcare systems expert with an extensive background in Quality and IT management, Project Management, IT strategy development, LIMS and LIS implementation, and software development. I have had the privilege to lead or participate in many key business initiatives, such as creation of quality departments, creation and management of multisite teams, divestitures, mergers, and facilities transfers. I have worked for several key players in the biotechnology industry, such as Amgen, Isis Pharmaceuticals, and Biogen Idec.

My Expertise

  • Project Management
  • IT Strategy
  • Multisite Team Management
  • Business Process Improvement
  • LIMS and LIS implementation
  • Software Development
  • GMP, CLIA, HIPAA
  • Software Validation

Professional
Work Experience

View Jeffrey Lee, PMP, CSM's profile on LinkedIn

Senior Application Architect/LIS Manager / Iris International

July 2011 - February 2013

Technical lead role in the Information Technology team working to provide design, architecture, development, testing/validation, and end user support for the company's application portfolio. Primary focus on providing application support to the IRIS Molecular and ARISTA divisions in support of the Laboratory Information and related systems.


  • Assumed responsibility for a $500K LIS implementation project that had fallen behind schedule, and underwent a complete re-scoping and brought the project in on time and within the anticipated revised budget.

Senior Manager, Business Information Management / Biogen Idec

October 2009 - January 2011

Managed the IT relationship with the Process Development group at all three U.S. sites. Responsible for strategy development, process improvement, solution requirements and design, and planning and execution of IT capital projects.

Senior Manager, IT Technical Systems / Biogen Idec

January 2005 - October 2009

Managed the clinical, laboratory, regulatory operations, and document management platform support teams in San Diego. Headed up the West Coast LIMS implementation team, and served as IT Technical Systems lead on several major corporate initiatives.

Associate Director, Quality Systems and Standards/ Biogen Idec

January 2004 - January 2005

Managed the global Laboratory Systems group. Responsible for managing cross-functional business process harmonization and improvement teams, as well as serving as subject matter expert in quality, software validation, and continuous improvement for other teams.

Senior Project Manager, Quality Systems/ Idec Pharmaceuticals

January 2003 - January 2004

Responsible for managing projects related to LIMS implementation and the continuous process improvement program for the Quality department.

Various Positions/ Isis Pharmaceuticals

April 1991 - January 2003

Primary achievements were the establishment of Isis' Quality Assurance and Quality Control program, development of software systems to manage document control, manufacturing batch record issuance, review, and lot release, and calibration/maintenance of equipment, and key player in initiating clinical trials of a first in class compound.

Previous work experience : Multiple Peptide Systems, Amgen, UCLA Department of Chemistry and Biochemistry

Education
& Professional
Affiliations

BSc in Biochemistry / UCLA

September 1983 - June 1987

Member, Project Management Institute

Member, Scrum Alliance

Strengths

An individual with broad interests, and an insatiable desire for education
  • Autodidactic
  • Loves complex problem solving
  • Ready to take variety of projects
  • Gregarious
  • Needs to provide value
  • Constantly looking for new learning experiences
  • Effective leader
  • Effective mentor
  • Extensive experience
  • Love being unique and creative

Wants to talk

Contact here!