Senior Manager, Manufacturing @ (March 2011 - January 2013)
Senior Manager, Process Validation and Quality Lead @ (February 2005 - March 2011)
Validation Lead @ (February 2002 - February 2005)
Senior Validation Specialist @ (February 2001 - December 2002)
Validation Specialist (consultant) @ (May 1999 - February 2001)
Validation Engineer @ (July 1997 - May 1999)
Research Biologist @ (January 1993 - January 1994)
David Grote Education
University of Rhode Island
PHD inc. (PhD program in Biological Sciences)
1994-1997
Truman State University
Bachelor of Science - BS (Biology, General)
1989-1993
David Grote Skills
Artificial Intelligence (AI)
Aseptic Processing
Aseptic Technique
Auditing
Bacterial Cell Culture
Biochemistry
Biopharmaceuticals
Bioreactor
Biotechnology
Business Management
Business Strategy
CAPA
CIP systems
CMC Regulatory Affairs
CMO management
Capacity Development
Cell Culture
Change Control
Cleaning Validation
Clinical Operations
Combination Products
Communication
Compliance Regulations
Continuous Improvement
Contract Manufacturing
Corrective and Preventive Action (CAPA)
Creative Problem Solving
Cross-functional Team Leadership
Data Analysis
Design Control
Design for Manufacturing
Deviation Management
Director level
Executive Coaching
Executive Management
External Audits
FDA
FDA GMP
Financial Analysis
GMP
Global Cross-Functional Team Leadership
Global Regulatory Compliance
Good Clinical Practice (GCP)
Good Laboratory Practice (GLP)
Homogenization
International Project Management
Investigations
Investment Strategies
Laboratory Information Management System (LIMS)
Laboratory Skills
Mammalian Cell Culture
Manufacturing Operations
Manufacturing Operations Management
Manufacturing Processes
Marketing Strategy
Medical Devices
Mergers & Acquisitions
Operations Management
PAI
Pharmacovigilance
Process Validation
Project Management
Protein Chromatography
Protein Production
Protein Purification
Quality Assurance
Quality Auditing
Quality Control
Quality Operations
Quality Process Development
Quality System
Regulatory Affairs
Regulatory Compliance
Regulatory Examinations
Regulatory Reporting
Regulatory Requirements
Regulatory Strategy
Regulatory Submissions
Reverse Osmosis
Site Inspections
Small Business Development
Standard Operating Procedure (SOP)
Sterility Assurance
Sterilization
Strategy
Strategy Development
Supervisory Skills
TFF
Team Building
Technical Writing
Training and Development (HR)
U.S. Food and Drug Administration (FDA)
Ultrafiltration
University Teaching
V&V
Validation
Validation Master Plans
Verification and Validation (V&V)
accredited investor
cGMP
Downstream Processing
Cross Functional Team
Verification and Validation V&V
Data Validation
Microfiltration
International Project
Corrective and Preventive Action Capa
Cross Functional Team Leadership
Upstream Processing
u.s. Food and Drug Administration Fda
Biologics
Small Business
Mergers and Acquisitions
u.s. Food and Drug Administration
Corrective and Preventive Action
Verification and Validation
David Grote Summary
David Grote, based in United States, is currently a Vice President of Strategy at GrayMatter Partners. David Grote brings experience from previous roles at Curadian Group, Immunocore and Teva Pharmaceuticals. David Grote holds a 1994 - 1997 PHD inc. in PhD program in Biological Sciences @ University of Rhode Island. With a robust skill set that includes Artificial Intelligence (AI), Aseptic Processing, Aseptic Technique, Auditing, Bacterial Cell Culture and more. David Grote has 2 emails and 5 mobile phone numbers on RocketReach.
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