Mike Shanks
Interdisciplinary Scientist - Biologist, Cder and Opq and Opf and Division of Inspection Assessment, Branch 1
Name variants:
Michael Shanks
Contact Information
Last Update
Jul 7, 2022
Email
mi**@fda.gov, mi**@gmail.com
Location
Washington, DC
Company
Workplace
Colleagues
Work History
Purification Scientist
Purification development and GMP production of monoclonal antibodies and proteins as clinical assay components in support of a novel medical device.
Oct 2013 — Feb 2014
Interdisciplinary Scientist - Biologist, Cder and Opq and Opf and Division of Inspection Assessment, Branch 1
10903 New Hampshire Ave, Silver Spring, MD 20903
Office of Process and Facilities CMC review of BLA, NDA, and ANDA applications and supplements, include manufacturing facility regulatory inspections.
from Feb 2014
Process Development and Technology Transfer Manager
Apr 2004 — Feb 2013
Research Associate Ii
Responsible for process purification improvements that led to increased product sterile filtration recovery, 90 to 100%.
Improved product storage and stability conditions through process a...
Mar 1998 — Mar 2000
Senior Research Assistant Ii, Sch of Med., Dept.of Cell Biology and Anatomy
3400 north Charles Street Ave, Baltimore, MD 21204
Nov 1993 — Mar 1998
Senior Research Assistant I, Sch of Med., Department of Cell Biology and Anatomy
3400 north Charles Street Ave, Baltimore, MD 21204
Performed real time video imaging of vesicular transcytosis for 5 'nucleotidase, polymeric plgA-receptor, Endolyn-78, aminopedtidase N and alfa-2 macroglobin in the WIF-B cells. Developed hy...
Feb 1991 — Nov 1993
Research Associate, Sch.of Med., Department of Dermatology
3400 north Charles Street Ave, Baltimore, MD 21204
1986 — 1993
Education
1991 — 1994
1982 — 1985
Occupations
Scientist
Biologist
Biotechnology Professional
Bachelor of Liberal Arts
Biological Scientist
Skills
Assay Development
Purification
Technology Transfer
Biotechnology
Gmp
Elisa
Cell
Validation
Fda
Protein Chemistry
Cell Biology
R&D
Pharmaceutical Industry
Protein Purification
Virology
Immunoassays
Filtration
Biochemistry
Cell Culture
Molecular Biology
Life Sciences
Monoclonal Antibodies
Hplc
Laboratory
Chromatography
Biopharmaceuticals
Glp
Clinical Development
Microbiology
Antibodies
Sop
Immunology
Electrophoresis
Process Simulation
Tissue Culture
Lifesciences
Vaccines
Drug Discovery
Quality Assurance
Transfection
Affinity Chromatography
Gel Electrophoresis
In Vivo
Cglp/Cgmp
Capa
Change Control
Commercialization
FAQs about Mike Shanks
What is the main profession of Mike Shanks?
The expert is a Interdisciplinary Scientist - Biologist, Cder and Opq and Opf and Division of Inspection Assessment, Branch 1.
What jobs is Mike proficient at at?
The expert is a professional such jobs as Scientist and Biologist.
Where is Mike Shanks located?
Mike is currently located in Washington, DC.
What is Mike Shanks's email?
The expert's email is mi**@fda.gov and mi**@gmail.com.
How many companies did Mike Shanks work at?
Mike Shanks worked at eight jobs.
What education does Mike Shanks have?
Mike studied at the Johns Hopkins University from 1991 to 1994.
Are there any professional certifications Mike Shanks has?
The professional received the following certifications: Aed, Cpr, Basic Medic First Aid, and Fire Extinguisher Training.
What languages does Mike Shanks speak?
Mike Shanks speaks English, German, and Spanish.