Deborah Shnek
Executive Director, Drug Product Technology at Resilience
- Role
- Executive Director, Drug Product Technology at Resilience
- Location
- Seattle, WA, US
- LinkedIn followers
- 500 followers
About Deborah Shnek
Seasoned leader specializing in commercializing biotech products. I have successfully scaled-up mABs, vaccines (gene therapy), proteins, and antibody drug conjugates. Provided manufacturing solutions for both early and late stages of biopharmaceutical development including combination products-Commercialization CMC strategy for biologics including monoclonal antibodies, vaccines, peptides, conjugate antibodies, fusion proteins including combination product - device strategy-Capital projects and commissioning -CQA strategy development and comparability protocols-Bioprocess development of microbial and mammalian cells-Scale-up / technology transfer for Phase I through late stage including CMO selection for drug substance and drug product. Experienced author providing process transfer documents, process characterization protocols, stability studies, and scope of work-Regulatory document preparation: IND through marketing application-Selection of contract manufacturing, process characterization strategy and validation. Specialties: Process development, technology transfer, process characterization, comparability, statistical analysis, experimental design, formulation development for frozen, liquid, controlled release, and lyophilized drug products in cartridges, vials, syringes and devices.
Experience
Executive Director, Drug Product Technology
Mar 2021 — Present
Responsible for drug product technology across the Resilience network.
Education
Caltech
PhD, Chemical Engineering
Massachusetts Institute of Technology
B.S., Chemical Engineering
Caltech
M.S., Chemical Engineering
Skills
- Protein Chemistry
- Antibodies
- Commercialization
- Machine Vision
- Lifesciences
- Purification
- Fda
- Formulation
- Gmp
- Process Validation
- Vaccines
- Product Development
- Technology Transfer
- Monoclonal Antibodies
- Regulatory Requirements
- Ind
- Manual Inspection, Automated Inspection, Biologics, Regulatory Filings
- Automated Inspection
- Life Sciences
- Biologics
- Manufacturing
- V&V
- Process Simulation
- Stability Studies
- Validation
- Biotechnology
- Regulatory Submissions
- Combination Products
- Drug Development
- Medical Devices
- Biopharmaceuticals
- Characterization
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