Mark Ellsaesser
Pharmaceutical Manufacturing Technical Leader
- Role
- Director, Commercial Manufacturing at Pfizer
- Location
- Denver, CO, US
- LinkedIn followers
- 500 followers
About Mark Ellsaesser
Pharmaceutical manufacturing professional with 25 years of experience providing technical leadership and managing programs and complex projects.
Experience
Director, Commercial Manufacturing
Jan 2020 — Present · CO, US
Technical Team Lead for key commercial product (>$4B revenue); responsible for technical project portfolio to deliver capacity, robustness, business continuity, risk reduction, etc. Provide technical leadership and subject matter expertise for small molecule, solid oral dose products in the Pfizer network and external supply. Includes complex investigations, technology transfers, scale up, alternate sourcing, etc. Program lead for connecting local sites with global MS & T support, including acting as primary point of contact for Pfizer sites in Brazil and Mexico. Network strategy development for investment of manufacturing technologies to support development pipeline.
Education
Colorado State University
Bachelor's degree, Zoology/Animal Biology
1996 — 2000
Skills
- Change Control
- Pharmaceutical Process Development
- Gxp
- Experimental Design
- Quality System
- V&V
- Quality Assurance
- 21 Cfr Part 11
- Standard Operating Procedure (Sop)
- Pharmaceutical Industry
- Sop
- Fda
- Capa
- Gmp
- Project Management
- Biotechnology
- Deviations
- Pharmaceutical Manufacturing
- Validation
- Cleaning Validation
- Technology Transfer
- Glp
- U.s. Food and Drug Administration (Fda)
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