Polio and Pharmaceutical Aspiration
Peng was born to poor and disabled parents in a remote rural area in China. At age of three, Peng was hit by polio. Since then Peng's parents have been making enormous efforts in search of effective treatment. With hard work and perseverance, Peng's dream finally came true. In 1982 he was accepted as a pharmaceutical college student after three years of his father's persistent battles with the College Entrance Selection Committee. At that time, a student's physical condition was one of the three criteria for selection even though Peng's academic grades were excellent in his province. Peng focused on studying during his 11 years in college, and finally graduated with excellent merits in pharmaceutical sciences (B.Sc., 1986), pharmaceutical chemistry (M.Sc., 1989), and analytical chemistry (Ph.D., 1993) from Shenyang Pharmaceutical University, followed by outstanding research experiences in Beijing Institute of Pharmaceutical Sciences (1993-1995), Meiji College of Pharmacy (1995, Japan), University of British Columbia (1996, Canada), and University of Wisconsin-Madison (1997-1999, USA).
An Outstanding Pharmaceutical Scientist
Dr. Peng joined pharmaceutical industry in 1999 as Group Leader of Analytical Development and Quality Control in Synsorb (Canada) then QLT Inc. (Canada) before he joined Eli Lilly and Company as a Responsible Scientist in Tippecanoe Quality Control/Analytical Services Laboratories in 2003 and was subsequently promoted to Team Leader for over 30 senior analytical chemists and microbiologists.
During his 14-year career at Eli Lilly, Dr. Peng has provided business oversight and technical leadership in analytical development and validation, technology transfers, quality control testing, batch release, cleaning and microbiological/endotoxin testing, method remediation, and commercialization of many development molecules and commercial products.
Dr. Peng has led cross-functional teams with development and commercial sites for technology transfers, analytical and process validation, and commercial launches. Dr. Peng was recognized for his contributions to regulatory submissions, quality inspections, investigational testing, deviation resolutions, and new technology implementations at the Tippecanoe plant.
Dr. Peng transferred to Manufacturing Science and Technology Commercialization Center in 2009 and has worked with CMOs in Asia, Europe and US, served as the QC/Analytical Leader for process development, commercialization, due diligence for sourcing and in-licensing projects, product registrations in major markets, product transfers from external CMOs, technical stewardship for Lilly products manufactured in CMOs, conducted vendor evaluations and quality audits in Asia, US, and Europe.
Dr. Peng has made contributions to the holistic reviews for many commercial products in response to FDA audit action plans; he provided important insights into Chinese CMOs on multiple trips in recent years. Dr. Peng has played a major role in obtaining FDA approval of the new Alimta process from a quality control and analytical chemistry perspective. Dr. Peng authored and reviewed over 900 drug development and quality documents. He presented on analytical development, method optimization, validation and transfers in the analytical R&D seminar series, global quality control forums and external CMC conferences.
Dr. Peng completed Executive MBA in Purdue University with excellent grades in 2009. He received recognitions from senior management for contributions and leadership in successful transition of the Tippecanoe site, technical stewardship and oversight of projects done at multiple CMOs and contributions to due diligence of sourcing and in-licensing products.
Due to his technical contributions and leadership across multiple CMO networks in rapid development and obtaining FDA approval of Pemetrexed New Chemistry, Dr. Peng was selected as one of the winners of the 2012 LRL President’s Scientific Recognition Award, the most prestigious scientific award offered by Eli Lilly Research Laboratories.
In 2013 Dr. Peng was promoted to Advisor for Project Management to provide leadership for multiple Manufacturing Process Transfers from Europe to China, which involved cross-functional teams (manufacturing process and technical service, QA/QC, health, environmental and safety, packaging and labeling, supply chain, procurement, finance, and global regulatory registrations), internal stakeholders and external partners. All technical transfers were completed successfully following resolutions of technical issues during process validation and successful investigations. Dr. Peng received recognition from management for his accomplishment.
In 2015 Dr. Peng joined Global Quality Control Laboratories as Advisor for Global Quality Control Integration upon Lilly’s acquisition of Novartis Animal Health. Dr. Peng managed business critical projects with cross-functional groups for top selling products, and led efforts to harmonize processes and share best practices across global QC networks. Dr. Peng worked well with cross functional teams and stakeholders (manufacturing, quality, R&D, CMC regulatory, statisticians) to successfully launch Specification Committee which now governs all new product specifications prior to regulatory submissions and post-approval specification changes. Dr. Peng created and maintained an engaging work-together culture and chaired Specification Committee as a simple, flexible, and necessary process to ensure product quality, compliance, and regulatory approval. Dr. Peng received recognition from customers and committee members.
Junpeng Peng, Ph.D., MBA, Founder and Sr. Advisor
2012 Eli Lilly President Award
Executive MBA, Purdue University
cGMP Quality Control
Process Validation and Transfer