Michael Schmidt
- Role
- Senior Director Clinical Drug Prodct Manufacturing at Pfizer
- Location
- South Hamilton, MA, US
- LinkedIn followers
- 500 followers
About Michael Schmidt
Michael is a Senior Director in the Pharmaceutical Research and Development group (PhRD)…
Experience
Senior Director Clinical Drug Prodct Manufacturing
Oct 2016 — Present
Michael is a Senior Director in the Pharmaceutical Research and Development group (PhRD) within the BioTherapeutics PharmSci organization, based in Andover, Massachusetts. In his PhRD leadership role, Michael has built a high-functioning team of over 70 members across multiple sites who drive flexible, efficient manufacturing of highly complex processes. This team manages Pfizer’s large molecule internal and external clinical Drug Product (DP) manufacturing capability. Michael\'s group is responsible for Clinical DP Manufacturing, which is split into two parts. The first has responsibility for the technology transfer process for BTx DP into GMP manufacturing sites internally and externally. The second part of the group is the Andover Liquid Dosage Manufacturing (AN-LDM) clinical BTx DP manufacturing facility, which is the primary Phase I/II manufacturing facility for Pfizer’s biotherapeutic portfolio. This facility manufactures different product modalities and processes including complex formulations, aseptic formulation of vaccine adjuvants, and lyophilization, as well as Lipid Nanoparticles (LNPs) including RNA. Additionally, Michael has provided critical support for drug product technology transfer and the design of a $350 million state-of-the-art Global Biotechnology Center in the Hangzhou Economic Development Area (HEDA) in China. Michael has been employed by Genetics Institute/Wyeth/Pfizer since He has experience and interest in aseptic processing, with a focus on optimization of small-to-mid-scale biologic fills to enable flexible, scalable, cost-effective, timely, and compliant production.
Skills
- Aseptic Processing
- R&D
- V&V
- Clinical Research
- Fda
- U.s. Food and Drug Administration (Fda)
- Validation
- Manufacturing
- Pharmaceutical Industry
- Drug Development
- Quality Control
- Microbiology
- Regulatory Affairs
- Quality Assurance
- Life Sciences
- Gmp
- Lims
- Technology Transfer
- 21 Cfr Part 11
- U.s. Title 21 Cfr Part 11 Regulation
- Clinical Development
- Biopharmaceuticals
- Laboratory
- Vaccines
- Change Control
- Sop
- Process Simulation
- Capa
- Lifesciences
- Biotechnology
- Medical Devices
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.