Reed Harris - Technical Development Senior Staff Scientist, Global Technical Development (PTD)

Reed Harris

Technical Development Senior Staff Scientist, Global Technical Development (PTD)

Staff Scientist
"I enjoy reducing seemingly complex issues to simple clear concepts that enable strategic clarity and efficient decision-making, and I love to tell stories about how we developed new analytical tools and understanding to enable the licensing of important new therapies."
33
Years at Genentech
43
Publications
1
Awards & Honors

After earning a Bachelor’s degree in Biochemistry from UC-Berkeley, I worked in the protein chemistry labs at the Gladstone Institutes in SF and then at Cetus (a biotech company) in Emeryville. In 1984, I joined Genentech’s nascent Analytical Chemistry group in process development, initially in molecular characterization roles for development products. I was promoted to Scientist in 1992, and then Senior Scientist in 1997, largely based on original studies that identified unexpected and often novel protein modifications and variants, which also led to the good-natured “Dr. Doom” honorific awarded to me by project team colleagues.

I was the global Xolair Genentech/Novartis CMC team leader from Phase II through the initial licensing stage, and led a Development Sciences team that brought in an external product. I was the head of PTD analytical development and QC functions from 2004 to 2014, during which we developed our successful ongoing strategies for comparability assessments, clinical specifications, critical quality attribute identification, and Quality by Design commercial control strategies. I was also the ad interim head of Roche’s global PTD-Quality function (2014 to 2015).

Featured Publication

O-Linked fucose and other post-translational modifications unique to EGF modules. (Review article).

Glycobiology 1993, 3, 219–224.

RJ Harris & MW Spellman.

Assessing genetic heterogeneity in production cell lines: Detection by peptide mapping of a low level Tyr to Gln sequence variant in a recombinant antibody.

(Nature) Bio/Technology 1993, 11, 1293–1297.

RJ Harris, AA Murnane, SL Utter, KL Wagner, ET Cox, G Polastri, JC Helder, MB Sliwkowski.

Identification of Multiple Sources of Charge Heterogeneity in a Recombinant Antibody.

Journal of Chromatography B 2001, 752: 233–245.

RJ Harris, B Kabakoff, FD Macchi, FJ Shen, M Kwong, J Andya, SJ Shire, N Bjork, K Totpal, AB Chen.