Shane Karnik
- Role
- Senior Laboratory Director, Bioanalytical at Aliri Bioanalysis
- Location
- Colorado Springs, CO, US
- LinkedIn followers
- 500 followers
About Shane Karnik
I have been in the regulated bioanalysis industry for over 20 years. During that time, I…
Experience
Senior Laboratory Director, Bioanalytical
Jun 2019 — Present
Responsible for the technical operations of the laboratory including compliance of technical and laboratory policies, procedures, and conduct as well as Good Laboratory Practices (GLP) and other pertinent regulations established by the Food and Drug Administration or other regulatory agencies. Responsible for technical and operational management of assigned projects. Such leadership includes filling the role and satisfying the duties of Principal Analytical Investigator for applicable projects. The Senior Laboratory Director will also support internal resources and customers by applying current scientific, regulatory, and project management expertise to establish experimental design. The Senior Laboratory Director must demonstrate strong collaborative leadership, management, customer communications, and supervisory skills in addition to the relevant technological competencies.
Education
University of Colorado Colorado Springs
Masters of Science, Chemistry
1994 — 1999
Skills
- Regulatory Submissions
- Hplc
- Regulatory Affairs
- Organic Chemistry
- Formulation
- Pharmaceutical Industry
- Toxicology
- Adme
- Bioanalysis
- In Vitro
- Lc-Ms
- Capa
- Assay Development
- Drug Discovery
- Method Development
- Glp
- Ind
- Scientific Writing
- Lifesciences
- Biotechnology
- Biochemistry
- Drug Metabolism
- Dmpk
- Gc-Ms
- Chromatography
- Pharmacology
- Chemistry
- Uv/Vis
- Validation
- Analytical Chemistry
- Clinical Development
- Biopharmaceuticals
- Fda
- Sop
- CRO
- Gas Chromatography
- Drug Delivery
- Program Management
- Mass Spectrometry
- Lc/Ms/Ms
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