Steve Speer Email & Phone Number

Sr, Mgr. Manufacturing Quality Operations and Validation Engineer

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Steve Speer Location

West Sacramento, CA, US

Steve Speer Work

2018 -now Sr, Mgr. Manufacturing Quality Operations and Validation Engineer @ Thermofisher Scientific (formerly Mesa Biotech)
2017 -2018 Quality Systems @
2012 -2017 Assoc. Director Operations, West Region @
2012 -2012 RA and QA @
2010 -2012 Project and Program Manager @
2005 -2010 Sr. Mgr., Head, Quality Control and Product Realization @
2005 -2008 Sr Mgr @
2004 -2006 Technical Consultant @ Eyetech Pharmaceuticals
1999 -2005 Director of Manufacturing and Operations @ Chromagen
1990 -1998 Senior Manager, Manufacturing @ Chiron Corporation
1984 -1990 Supervisor and Manager @

Steve Speer Education

California Polytechnic State University-San Luis Obispo
BS (Microbiology)
1975-1979

Steve Speer Skills

Manufacturing Operations
Internal Audits
Manufacturing Operations Management
Regulatory Compliance
Risk Management Systems
GAMP5
Quality Systems
Validation
Quality System
GMP
GAMP
Technology Transfer
Risk Management
FDA
Quality Assurance
V&V
Medical Devices
Biotechnology
Sop
Lifesciences
ISO 13485
Biopharmaceuticals
Assay Development
Six Sigma
Manufacturing
Continuous Improvement
Quality Management
ISO
Product Development
Cross-functional Team Leadership
DNA
CAPA
Root Cause Analysis
Change Control
Design Control
21 CFR Part 11
Quality Control
Quality Auditing
GLP
Regulatory Affairs
R&D
Pharmaceutical Industry
Lean Manufacturing
GxP
Computer System Validation
Drug Discovery
Aseptic Processing
Cleaning Validation
Life Sciences
LIMS
Consulting
Financial Performance
Corrective Actions
Organic Synthesis
Cost Accounting
Net
Oligonucleotides
Cost
Macular Degeneration
System Upgrades
Strategize
Performance Metrics
Serving
SAN
Lipids
Reagents
Highly Detailed
Road
On Time Delivery
Ela
Construction
APIs
RNA
Product Flow
Cross Functional Team Leadership
Batch Processing
Complaints
Detection
TQM
Microbiology
Toolbox
Sphere
Management
Revenue
Outsourcing
Shop Floor
Guiding
Metrics
Aseptic
Initiation
Stand Alone
Gen
Exceeding Expectations
Synthetic
Product Validation
Ahead of Schedule
21 CFR
Human Resources
Methodology
Realization
Antibodies
Instrumentation
Process Validation
System
Cell
PCR
Iso 9000
New Process
Strategies
Contamination
Testing
Training
Policy
Customer Service
Materials Management
Clean Rooms
Bankruptcy
Supply
Project Management
Contamination Control
Manufacturing Processes
High Performance Computing
Environmental Monitoring
Harvest
Inspection
Process Simulation
Constraints
Bioprocessing
Laboratory
Concepts
Dna Replication
Nucleic Acid
Probe
Pai
Product Transfer
FIX Protocol
Business Acumen
Applications
Business Development
Schedules
Home
Business Alignment
Cell Culture
ERP
Active
Cost Savings
EHS
Licensing
Operations
Workshops
Stage
Triage
Maturity
Molecular Biology
Forward Thinking
Maps
Document Management
Enterprise Business
Philosophy
Project
Distribution Center Operations
Contractual Agreements
Metric
Facilities Management
Mechanism
Responsibility
Internal Audit
Packaging
Labelling
Distribution
High Throughput Screening
Contract Management
Breadth
Health and Safety
Pilot Plant
Google Groups
Oracle Enterprise Manager
Start Ups
Warehousing
New York
Diagnostics
Software
Hybridization
San Diego
Bulk
Compliance
Continuing Education
Canada
Human Potential
Program Management
Pharmaceutics
Interest Rates
Budgets
Formulation
Scientists
Pre Approval
MRP
Lyophilization
Sterility

Steve Speer Summary

Steve Speer, based in West Sacramento, CA, US, is currently a Sr, Mgr. Manufacturing Quality Operations and Validation Engineer at Thermofisher Scientific (formerly Mesa Biotech). Steve Speer brings experience from previous roles at Synthetic Genomics, ProPharma Group and GenMark Diagnostics. Steve Speer holds a 1975 - 1979 BS in Microbiology @ California Polytechnic State University-San Luis Obispo. With a robust skill set that includes Manufacturing Operations, Internal Audits, Manufacturing Operations Management, Regulatory Compliance, Risk Management Systems and more. Steve Speer has 3 emails and 4 mobile phone numbers on RocketReach.