Carlos Lugo
Accomplished professional with extensive QA, RA, Compliance, Validation and Manufacturing experience...
San Francisco, California, United States
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Carlos Lugo’s Email carlos.lugo@bayer.com
Social Media
Carlos Lugo’s Location San Francisco, California, United States
Carlos Lugo’s Current Industry Sutro Biopharma
Carlos Lugo’s Prior Industry Bayer | Merck | Hospira | Johnson And Johnson | Bristol Myers Squibb | Baxter International
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Work Experience
Sutro Biopharma
Senior Vice President, Quality
2023-03-01 00:00:00 - Present
Bayer
Director Global Quality Systems & Combination Products
2014-10-01 00:00:00 - 2016-03-01 00:00:00
Merck
Director of Quality and Compliance, Drug Delivery Devices, Vaccines and Biologics
2012-09-01 00:00:00 - 2014-10-01 00:00:00
Hospira
Director, Device Quality Operations
2010-11-01 00:00:00 - 2012-09-01 00:00:00
Johnson And Johnson
Associate Director, Post Market Surveillance
2008-12-01 00:00:00 - 2010-11-01 00:00:00
Bristol Myers Squibb
Senior Manufacturing, Regulatory & Compliance Positions
1995-12-01 00:00:00 - 2004-10-01 00:00:00
Baxter International
Manufacturing Supervisor
1994-12-01 00:00:00 - 1995-12-01 00:00:00Skills
Languages
FAQ About Carlos Lugo
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Carlos Lugo is located at
San Francisco, California, United States -
Carlos Lugo is a Accomplished professional with extensive QA, RA, Compliance, Validation and Manufacturing experience at both the manufacturing and corporate levels in both pharmaceutical and medical device industries (including working knowledge of combination products). Strategic leader with proven track record of success and high focus on results. Experience: CMO Quality Oversight, Risk Management/Post Market Surveillance, Design Controls, CAPA, Field Actions, Quality Systems, Change Control, Investigations, Complaints, Internal and External Audits, Document Control, Supplier Quality, SOPs, Qualification and Validation, Chemical and Microbiology Laboratories OOS. Company Corporate, FDA, MCA, TGA and third parties audits, and inquiries, Stability Programs. Domestic and International Regulatory Affairs: NDA, PMA, 510ks submissions and reports. CMC changes and associated submissions. Exposure/working knowledge: Vaccines, Biologics, Medical Device/Drug Device/Biologic Device Combination Products, Cardiovascular, Endovascular, Electromechanical, Consumable Medical Devices, Bulk, Aseptic Bulk, Parenteral (including Media Fills), Oral Solid Dosage, Liquids, Solutions, Creams and Aerosol Pharmaceuticals. Critical Systems: WFI, DI, compressed air, nitrogen and HVAC. Lean Manufacturing and Six-Sigma. Specialties: Quality Assurance, Regulatory Affairs, Compliance, Validation and Manufacturing
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Carlos Lugo currently works in the Sutro Biopharma |
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No Languages Available
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Carlos Lugo has prior
experience in the following industries:
Bayer | Merck | Hospira | Johnson And Johnson | Bristol Myers Squibb | Baxter International -
Carlos Lugo has the following professional experience:
Sutro Biopharma | Bayer | Merck | Hospira | Johnson And Johnson | Bristol Myers Squibb | Baxter International -
You can view Carlos Lugo’s LinkedIn profile at LinkedIn URL
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Carlos Lugo’s work email
addresses are
carlos.lugo@bayer.com -
Sutro Biopharma |
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