Jeff Welch has over 30 years of CMC experience in the process development, GMP manufacturing and facilities, and regulatory documentation.
In Jeff’s most recent role as a consultant he has had responsibility for authoring and reviewing regulatory filing sections related to process development and product characterization.
Over the past decade Jeff has focused on his role as a senior director for drug substance (DS) process development and director over process engineering and operations for a specialty pharmaceutical company working in biologics and vaccines and as a CDMO organization.
Jeff has also served as a project manager for large scale manufacturing and technology transfer projects and filled the DS team leader role. After a lead role in engineering and construction, he served as a senior manager over the start up effort for a stainless steel cell culture facility (1600 L scale), where he hired and managed personnel and led a 7-day-a-week cGMP manufacturing operation for the upstream portion.
In his early career he participated in design of a multi-product manufacturing facility and after start-up performed process fit and technology transfer activities for several microbial, yeast and cell culture products.
Learn more about Jeff Welch