Stacey Shank
Sr. Scientist- Bioanalytical Strategy at Regeneron Pharmaceuticals, Inc.
- Role
- Sr Scientist, Bioanalytical Strategy at Regeneron
- Location
- Tarrytown, NY, US
- LinkedIn followers
- 500 followers
About Stacey Shank
Bioanalytical Scientist with 19 years of experience in the pharmaceutical/biotechnology industry supporting large molecule, regulated bioanalysis. Currently providing cross-functional support within the organization between bioanalytical labs and clinical study teams.
Experience
Sr Scientist, Bioanalytical Strategy
Jan 2025 — Present
Serves as the Bioanalytical Sciences Lead in support of clinical bioanalysis of PK, immunogenicity, and biomarkers in immuno-oncology, cardiovascular & metabolism, and siRNA gene therapy therapeutic areas by bridging the bioanalytical team and clinical study teams.Reviews and contributes to clinical study documents including, but not limited to, clinical protocols and amendments, statistical analysis plans, and clinical study reports.Leads efforts in developing Immunogenicity Risk Assessments (IRA) as needed to support the Integrated Summary of Immunogenicity (ISI) for regulatory filings. Contributes to regulatory submissions and responses to Health Authority and other regulator inquiries.
Education
Millersville University of Pennsylvania
B.S., Molecular Biology/Biotechnology
2003 — 2007
Skills
- Translational Medicine
- Pharmacokinetics
- Immunology
- Assay Development
- Drug Discovery
- Research
- Protocol
- Molecular Biology
- Immunoassays
- CRO
- Drug Development
- Bioanalysis
- Elisa
- Glp
- Validation
- Laboratory Information Management System (Lims)
- Biotechnology
- Antibodies
- Pharmaceutical Industry
- Sop
- Lims
- Clinical Development
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