Biogen Project Management

memorandum

to: Jim Mullen, VP of Operations at Biogen Inc.

from: Nina Quinn, Project Management Consultant

subject: rBeta Interferon Manufacturing Process Development

date: [ 8/1/2012 ]

RE: Analysis recommendations for Project management

OVERVIEW

I have had the opportunity to learn of, analyze, and asses Biogen, Inc.’s rBeta Interferon Manufacturing Process Development protocol. Despite both internal and external issues with this project roll-out, which I will address in this memo, I am impressed with the progress made and hope to be able to assist in setting up the company for success for both the remainder of the rBeta Interferon Manufacturing project, as well as future projects of similar specifications.

For an organizational culture unfamiliar with utilizing rigid project management structures, Biogen Inc. has done well in initiating a more rigid project management structure into its project roll outs. For such an important project as the rBeta project, it was vital that the project roll out as smoothly as possible. Organizational leadership understood this project importance and utilized project management principles to help ensure success. The three basic measurable aspects of a project are scope (or quality), budget, and time. The fourth element in the success of a project, which is just as important as the three measurable components, though a bit more intangible, is the “human element.” This refers to the gelling of the project team members.

Especially within the pharmaceutical industry, which is highly regulated, quality is the biggest non-negotiable as the final product need to meet rigid FDA quality control checkpoints. The rBeta team did a good job outlining important tasks and timelines and developing systems to best stay on track.

In the write-up provided me regarding the rBeta project, the team did well in not only identifying successes, but also in being honest about challenges and room for improvement both within this specific...