We found the following information about Michael Hellerstein at Airway Therapeutics, where this expert has worked as a Vice President, Regulatory Affairs and Quality since 2020. Michael's total work experience is over 23 years, during which time this person had at least 12 jobs at different companies to develop skills. Michael studied at the Harvard University from 1996 to 1999. Currently, Michael Hellerstein lives in Atlanta, Georgia. You can contact with Michael by looking for phone number or email address or get additional information by requesting access to this person's additional details from us.
Name variants:
Mikael Hellerstein,
Mychael Hellerstein,
Mike Hellerstein,
Mikey Hellerstein,
Mick Hellerstein,
Mickey Hellerstein,
Micky Hellerstein,
Michl Hellerstein,
Mischa Hellerstein
Contact Information
Last Update
Jul 8, 2022
Email
he**@gmail.com, mh**@geovax.com
Location
Atlanta, GA
Company
Workplace
Vice President, Regulatory Affairs and Quality
Cincinnati, OH
Industry
Biotechnology, Commercial Physical Research
Colleagues
Work History
Vice President, Regulatory Affairs and Quality
11804 Conrey Rd SUITE 175, Cincinnati, OH 45249
from Jun 2020
Director of Regulatory Affairs and Quality Assurance
Regulatory and Quality leader at Kiel Laboratories, an innovative drug development company focused on addressing unmet medical needs through creative strategies, advanced laboratory analysis...
from Aug 2019
Director, Regulatory Affairs and Quality Systems
1900 Lake Park Dr SUITE 380, Smyrna, GA 30080
Project manager for product development and outsourced manufacturing. Manage regulatory submissions and FDA interface. Develop and implement regulatory strategies to advance products through...
Jun 2014 — Aug 2019
Co-Founder and Executive Vice President Ops
1900 Lake Park Dr southeast, Smyrna, GA 30080
Co-founded Responsive BioServices, a CRO providing laboratory testing in the fields of virology and immunology along with a suite of complementary services. RBS's core service offering is th...
from Dec 2017
President
Founded Hellerstein Consulting in order to provide flexible, innovative solutions to life science organizations. Develop client Quality Systems, including SOPs, document control systems, and...
from Nov 2012
Director of Quality Control
1900 Lake Park Dr SUITE 380, Smyrna, GA 30080
Responsible for the in-house and outsourced Quality Control testing of GeoVax vaccines. Director of Quality Control group. Direct development, execution, qualification, and validation of GLP...
Feb 2006 — Nov 2012
Co-Founder
50 Prescott St, Worcester, MA 01605
Co-founded Blue Sky Biotech, Inc., a contract research company; built and managed the laboratory operations.
ACCOMPLISHMENTS
Built laboratory from scratch. Acquired equipment on used mark...
Jun 2003 — Jan 2005
Assistant Scientist
New York, NY
In protein chemistry department at Pfizer technology center, performed protein expression and purification studies and generated proteins for drug discovery projects.
ACCOMPLISHMENTS
Impr...
Jun 2001 — Jun 2003
Research Associate
3 Trask Ln, Danvers, MA 01923
Performed testing and product development of monoclonal antibodies for use in signal transduction research.
Jun 2000 — Jun 2001
Student Assistant
25 Shattuck St, Boston, MA 02115
Assisted scientists in the laboratory of Kevin Struhl.
1997 — 1999
Summer Lab Assistant
Assisted in laboratory testing of experimental veterinary vaccines.
1994 — 1998
Education
1996 — 1999
Occupations
Executive
Vice President
Scientist
Biotechnology Professional
IT Professional
Software Tester
Director
Leader
Chief Executive
Biologist
Biological Scientist
Computer Specialist
Operations Manager
Managers
Skills
Quality Assurance
Quality Control
Project Management
Team Management
Glp
Gmp
Fda Gmp
Capa
Deviation Management
Validation
Product Specification
Outsourcing
Quality Auditing
Vendor Management
Project Planning
Ms Project
Materials Management
Sop Development
Sop Authoring
Stability Programs
Stability Testing
Stability Studies
Equipment Qualification
Laboratory Skills
Laboratory Safety
Molecular Biology
Molecular Cloning
Sequence Analysis
Biochemistry
Cell Culture
Cell Biology
Protein Expression
Protein Purification
Quality System
Matrix Management
Theory of Constraints
Root Cause Analysis
Transfection
Pcr
Real Time Pcr
Gel Electrophoresis
Capillary Electrophoresis
Flow Cytometry
Elisa
Western Blotting
Fermentation
Laboratory Equipment
Supplier Quality
Quality Management
Microsoft Office