Vice President, Head Of Quality and Regulatory @ Argos Therapeutics (March 2017 - June 2018)
Senior Director Quality @ Argos Therapeutics (April 2016 - January 2017)
Senior Director Quality Assurance @ Argos Therapeutics, Inc. (NASDAQ: ARGS) (October 2013 - April 2016)
Quality and CMC Consultant @ CQI (June 2003 - October 2013)
Associate Director Quality Assurance and Process Validation @ Diosynth (February 1998 - April 2003)
Scientist @ (January 1996 - February 1998)
Laboratory Supervisor @ (September 1989 - July 1994)
Raisa Lowe Education
The Johns Hopkins University
Master's degree (Biotechnology)
1992-1994
Interamerican Univesity of Puerto Rico
Bachelor's degree (Biology, General)
1982-1987
Raisa Lowe Skills
Analytical Method Validation
Auditing
Batch Release
Biopharmaceuticals
Biotechnology
Budget Management
Business Strategy
CAPA
CDMO
CDMO Oversight
CMC
CMC Regulatory Affairs
CMCA
CMO Oversight
CMO management
CRO Management
CTO
Change Control
Chemistry, Manufacturing, and Controls (CMC)
Cleaning Validation
Clinical Development
Coaching
Commercial Operation
Communication
Continuous Improvement
Continuous Process Improvement
Corrective and Preventive Action (CAPA)
Cross-functional Team Leadership
Development and implementation of Global Quality Management Systems (GMP, GCP, GLP, GDP, PV)
Drug Development
EMA
Equipment Validation
Executive Management
FDA
GLP
GMP
Global Regulatory Compliance
Good Clinical Practice (GCP)
Good Laboratory Practice (GLP)
Good Manufacturing Practice (GMP)
Government Regulations
GxP
ICH
ISO 9001
Industry standards
Laboratory Information Management System (LIMS)
Laboratory Skills
Leadership
Life Sciences
Logistics Management
MHRA
Manufacturing Process Improvement
Master Control
PV
Personnel Management
Pharmaceutical Industry
Pharmaceutics
Problem Solving
Process Validation
Production Planning
Professional Development Programs
Quality Assurance
Quality Auditing
Quality Control
Quality Improvement
Quality Management
Quality System
Quality System Compliance
Regulatory Affairs
Regulatory Compliance
Regulatory Submissions
Risk Assessment
Spanish
Standard Operating Procedure (SOP)
Strategic Planning
Team Leadership
Technical Operations
Technical Transfer
Technology Transfer
TrackWise
U.S. Food and Drug Administration (FDA)
Validation
Validation (Drug Manufacture)
Veeva
Zen eQMS
produce release
Data Analysis
Science
Project Management
u.s. Food and Drug Administration Fda
Good Laboratory Practice Glp
Research
Standard Operating Procedure Sop
Corrective and Preventive Action Capa
Corrective and Preventive Action
Good Laboratory Practice
Standard Operating Procedure
u.s. Food and Drug Administration
Raisa Lowe Summary
Raisa Lowe, based in United States, is currently a Vice President, CMC Quality and Regulatory at Protara Therapeutics. Raisa Lowe brings experience from previous roles at Aviceda Therapeutics, Arbor Biotechnologies, Editas Medicine and Bristol Myers Squibb (Juno, Celgene). Raisa Lowe holds a 1992 - 1994 Master's degree in Biotechnology @ The Johns Hopkins University. With a robust skill set that includes Analytical Method Validation, Auditing, Batch Release, Biopharmaceuticals, Biotechnology and more. Raisa Lowe has 2 emails and 1 mobile phone numbers on RocketReach.
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