Kristan Latham
Director, Quality Control at AstraZeneca
- Role
- Director, Quality Control at AstraZeneca
- Location
- Frederick, MD, US
- LinkedIn followers
- 500 followers
About Kristan Latham
I started my career at MedImmune in process cell culture with an anti-RSV monoclonal antibody product where I performed inoculum, bioreactor, and media development work. I followed the product through Phase I, II, and commericial production before moving to QA at MedImmune\'s commercial monoclonal antibody production facility. While in QA I have had many roles, including managing quality at the source operations, bulk product release, and raw material release. I spent five years working on the design and start-up of MedImmune\'s new large scale manufacturing facility, which was named the Overall Winner of the 2011 ISPE Facility of the Year Award. As the Sr. Manager of QA Engineering I oversaw internal and external tech transfer of products both clinical and commercial into our large scale facility. Currently, I lead the Quality Control Analytical Testing team responsible for testing drug substance and drug product for release and stability.
Experience
Director, Quality Control
Nov 2017 — Present · Frederick, MD, US
Quality Control analytical testing of clinical and commercial products and raw materials
Education
The Ohio State University
BS, Chemical Engineering
1986 — 1991
UC San Diego
MS, Chemical Engineering with emphasis in Biotechnology
1991 — 1993
Skills
- Gmp
- V&V
- Monoclonal Antibodies
- Sop
- Fda
- Change Control
- Glp
- Root Cause Analysis
- Cell Culture
- Validation
- 21 Cfr Part 11
- Biopharmaceuticals
- Gxp
- Quality Auditing
- Aseptic Processing
- Quality Management
- Biotechnology
- Computer System Validation
- Technology Transfer
- Standard Operating Procedure (Sop)
- Manufacturing
- Verification and Validation (V&V)
- Capa
- Cleaning Validation
- Quality Assurance
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