Mike Shanks

Interdisciplinary Scientist - Biologist, Cder and Opq and Opf and Division of Inspection Assessment, Branch 1

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Michael Shanks

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Contact Information

Last Update
Jul 7, 2022
Email
mi**@fda.gov, mi**@gmail.com
Location
Washington, DC

Workplace

Purification Scientist

Industry

Biotechnology

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

Fda
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

Process Development Associate Iv

Mar 2000 — Apr 2004

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

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.
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