Manufacturing & Analytical Characterization
Selen Stromgren, PhD (she/her/hers)
Associate Director for Research
FDA/Office of Regulatory Affairs
Rockville, Maryland
Fengqiang Wang, PhD (he/him/his)
Principal Scientist
Merck and Co Inc
Kenilworth, New Jersey
This presentation will explore how to manage a transparent, accountable scientific lab network within a regulatory government agency that sustains an active and evolving research portfolio while executing core mission analytical obligations. Various system constraints will be discussed as well as creative management approaches to overcoming these challenges. The last part of the talk will provide examples of projects from the current research portfolio of the lab system and juxtapose these with the routine analytical obligations that need to be carried out and balanced against the research activities. Many of the themes covered in the presentation will be applicable to any large organization that by definition will have a framework of rules to manage its diverse operations. During an interactive session, questions will be explored with the audience about where innovation thrives best and what the right balance is between organizational rigidity vs chaos, hierarchical vs flat decision-making, individual accountability vs diffuse accountability.