Karen Rutherford
Experienced Pharma and BioTech Leader | Clinical CMC Strategy | Commercial Product Strategy | DP Formulation and Fill/Finish for mAb and ADCs | Clinical In-use Strategy | Intravenous and Subcutaneous Product Development
- Role
- Associate Director at 辉瑞
- Location
- Seattle, WA, US
- LinkedIn followers
- 500 followers
About Karen Rutherford
Multidisciplinary scientist responsible for investigating the stability, physio-chemical properties, and drug delivery system compatibility of protein and antibody formulations to support late stage clinical studies and regulatory submissions including BLA/MAA.Technical and strategic expertise in large molecule formulation and drug product manufacturing processes to support drug product validation and drug product process technology transfers to internal manufacturing sites and CMOs.Experience authoring and reviewing formulation and drug product related CMC sections of global regulatory submissions (IND, BLA/MAA, PAS) to support programs through late stage development and commercial launch.Extensive experience leading cross functional teams and developing direct reports in a matrixed structure.
Experience
Associate Director
Dec 2023 — Present
Education
Queen's University
BSc, Biochemistry
1995 — 1999
University of Washington - School of Medicine
Ph.D., Biochemistry
2002 — 2008
University of Edinburgh
Biological Sciences
1997 — 1998
Skills
- Molecular Dynamics
- Circular Dichroism
- Protein Chemistry
- Sec Mals
- X-Ray Crystallography
- Experimentation
- Small Angle X-Ray Scattering
- Fplc
- Protein Purification
- Biophysics
- Saxs
- Nmr
- Biochemistry
- Small Angle Neutron Scattering
- Dna Synthesis and Purification
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