Summary
Overview
Work History
Education
Skills
Websites
Equipment System Expertise
Timeline
Generic
Edwin Salazar

Edwin Salazar

Operations Manager
San Diego,CA

Summary

Mr. Edwin Salazar has over 11 years of experience in medical devices and 25 years of experience in cGMP/GDP environment. Mr. Salazar has been responsible for producing innovative biotherapeutic medicine by interfacing with highly automated production systems and controls in cGMP manufacturing environment while maintaining areas in high state of inspection preparedness. Experienced in cleaning and equipment validation, CIP, SIP, IQ OQ, PQ, automation equipment, validation skids in an aseptic environment. Validated autoclaves, parts washers, dryers. Performed cleaning validation, developmental runs, submitted and executed protocols, validated CIP and SIP skids. He has operated production equipment for cell culture that includes culture growth, process monitoring, sampling, harvesting, freeze thaw and transfer. Mr. Salazar has performed media solution preparation operations and has utilized and complied with cGMP and SOP to maintain records and clean room environment. He has experience in clinical and commercial environments supporting validation activities for biological facility/operation. Mr. Salazar has executed protocols such as Process Validation, computer-controlled system validation, complex utilities, complex manufacturing equipment, and basic knowledge of laboratory validation.

Overview

33
33
years of professional experience

Work History

Manager, Manufacturing

Abzena
03.2021 - 10.2022
  • Responsible for staff, functional area performance, recruiting, selection, hiring, training, performance evaluation, and development of staff.
  • Scheduling activities and allocating resources to support the planned activities.
  • Develop and execute facility, process and equipment validations with regulatory, corporate requirements and business requirements.
  • Collaboration with cross-functional teams i.e., QA, QC, materials management, engineering, facility, product research and development.
  • Identify risk and threats to the operation and pro-actively moved toward resolution.
  • Demonstrate the extensive knowledge and experience in biologics cGMP manufacturing.
  • Actively participate in technical transfer and implementation of processes including facility fit modeling based on client needs.
  • Increased team productivity by implementing streamlined processes and effective communication strategies.

Supervisor Manufacturing-MSAT

Abzena
03.2020 - 03.2021
  • Accountable for efficient and effective daily scheduling and assignment of appropriate resources to meet processing and product release schedules.
  • Experience and in-depth understanding of all systems lifecycle deliverable from Commissioning and Qualification (C&Q).
  • Assure daily end of shift review of completed batch records and logbooks.
  • Assure timely entry, investigation and review of quality documents.
  • Deviations, change controls, investigations.
  • Complete daily inventory and labor transactions.
  • Train, coach and manage production team members to ensuring adherence to cGMPs, written procedures (SOPs), housekeeping, 6S, use of electronic document and inventory systems (ERP), monitoring equipment and processes, product sampling, and equipment sanitization tasks.
  • Owns team and personal performance review, training and career development.
  • Increased team productivity by implementing efficient workflows and setting clear expectations for staff members.
  • Streamlined operations for increased efficiency through regular process reviews and implementing necessary changes.

Sr. Manufacturing Associate

Tanvex
08.2016 - 03.2020
  • Played a key role in ongoing compliance and continuous improvement of all aspects of compliance within the manufacturing area and process.
  • Determined root causes of problems and proposed and implemented effective corrective and preventive actions (CAPAs) to eliminate root causes.
  • Performed upstream productions activities in a GMP environment using disposable bioreactors.
  • Performed Microbial and Mammalian cell culture.
  • Improved production efficiency by streamlining assembly processes and implementing lean manufacturing techniques.
  • Enhanced product quality by conducting thorough inspections and adhering to strict quality control protocols.

Manufacturing Biologist III

MiliporeSigma
12.2015 - 08.2016
  • Responsible for performing cell culture, buffer and Media preparation, membrane clarification, TFF (UFDF) concentration and buffer exchange, column purification, terminal filtration, Fill and Finish, stocking supplies and raw materials, and cleaning in process equipment.
  • Responsible for drafting Batch Production Records and Standard Operating Procedures.
  • Provide supervision for GMP operations as necessary.
  • Train and development of Manufacturing Technicians.
  • Develop and execute IQ, OQ and PQ protocols for product, processes, facilities, software and equipment within the facility.
  • Increased species identification accuracy through regular collaboration with interdisciplinary teams.

Validation Engineer

ProPharma Group
10.2015 - 12.2015
  • Experience in executing protocols including complex systems such as Process Validation, computer-controlled systems validation, complex utilities, complex manufacturing equipment such as computer-controlled filling systems, formulation systems and basic knowledge of laboratory validation.
  • Familiarity with many aspects of validation is expected.
  • Depth in one or several areas is critical.
  • Possess effective skills for developing, performing, evaluating, and/or troubleshooting PLCs and control systems (including SCADA, Delta V, and BMS systems) is a plus.
  • Experience in Process Qualification execution.
  • Develop and execute IQ, OQ and PQ protocols for product, processes, facilities, software, and equipment within the facility.
  • Improved validation processes by developing and implementing risk-based strategies for equipment, systems, and facilities.

Senior Production Operator

Pacira Pharmaceuticals
06.2014 - 03.2015
  • Worked under current Good Manufacturing Practices following Standard Operating Procedures.
  • Knowledgeable and Operate computers using Automated Production for process control.
  • CIP/SIP, Solution Preparation, Diafiltration, TFF, Bulk, and filling.
  • Troubleshoot equipment and process problems.
  • Train/lead newly hired technicians on the company process.
  • Optimized production efficiency by implementing lean manufacturing techniques and reducing downtime.

Lead Manufacturing Bioprocess Technician

Genentech Inc. (Roche)
07.2008 - 06.2014
  • Responsible investigating/initiating TRNs and CAPAs.
  • Work under current Good Manufacturing Practices following Standard Operating Procedures.
  • Knowledgeable and Operate computers using Delta-V for process control: fermenters, sterilizing vessels, and harvesting systems.
  • Enhanced equipment performance by conducting regular maintenance and troubleshooting tasks.
  • Reduced downtime for machines through proactive identification and resolution of technical issues.
  • Train/lead newly hired technicians on cell culture processes.

Sr. Manufacturing Bioprocess Technician

Genentech Inc.
04.2005 - 07.2008
  • Responsible in operating Delta V, troubleshooting the bioreactors, media mix tanks, seed lab equipment, CIP skid, and other related equipment or systems at the NIMO facility.
  • Performed cleaning validation, developmental runs, submitted and executed protocols, validated CIP and SIP skids.
  • Involved in the installation and commissioning activities for Fermentation.
  • Involved in Installation Qualifications (IQs) and Operational Qualifications (OQs).
  • Participated in developmental, engineering runs and qualify lots.
  • Participated in drafting, reviewing or red-lining applicable SOP's.
  • Main interface with other departments to resolve issues related to equipment, process, compliance, including maintenance, metrology, and validation.
  • Resolve issues related to equipment, process and compliance. Main troubleshooting/response person.

Manufacturing Bioprocess Technician

Biogen-Idec
San Diego, CA
12.2001 - 04.2005
  • Utilizing automated systems to operate, clean and sterilize production equipment.
  • Operating small-scale cell culture areas and systems by using aseptic techniques, maintaining cell banks; and performing general seed lab operations.
  • Operating fermenters, centrifuges, other harvest systems and protein purification units.
  • Cleaning, assembling, and sterilizing equipment for production by operating glass washers and autoclaves.
  • Preparing solutions required for the production process (media and buffer make-up.
  • Collaborated with cross-functional teams to ensure timely completion of complex projects.

Logistic Specialist

IMED Corp. (Alaris Medical System)
01.1990 - 12.2001
  • Responsible for processing return goods and parts.
  • Responsible for shipping repaired parts/devices to customers.
  • Work under current Good Manufacturing Practices following Standard Operating Procedures.
  • Train/lead newly hired technicians on cell culture processes.
  • Improved supply chain efficiency by implementing new software and monitoring systems.
  • Reduced transportation costs through strategic route planning and carrier negotiations.
  • Implemented a successful vendor management program, ensuring timely deliveries and quality products.

Education

Associate of Arts - Computer Networking And Telecommunications

Kelsey-Jenney Business College
San Diego, CA
01.1998

Bachelor of Science - Microbiology

University of The Philippines
Quezon City
03.1989

Skills

  • SAP
  • Delta-V
  • LIMS
  • Trackwise
  • Power Point
  • Excel
  • Outlook
  • MS Word
  • ISO 9000
  • ISO 9001
  • Lean Manufacturing
  • 6S
  • Kaizen
  • Gemba
  • Strategic Planning
  • Workforce Management
  • Operations Management
  • Contract Management
  • Staff Development
  • Schedule Preparation
  • Verbal and Written Communication
  • Key Performance Indicators
  • Cross-Functional Teamwork
  • Staff Management
  • Team Leadership
  • Complex Problem-Solving
  • Time Management
  • Project Management
  • Performance Evaluations
  • Organizational Skills
  • Process Improvement
  • Decision Making
  • Quality Assurance
  • Risk Management

Equipment System Expertise

  • CGMP/GDP
  • Automated Controls
  • CIP/Skids
  • Mix Tanks
  • Automated Production Systems
  • NIMO
  • Validation Startup
  • Delta-V
  • Integrity Testing
  • Change Control Management
  • Nova Phox/YSI/Vi-Cell
  • Panda Plus 2000 Homogenizer/CEPA Centrifuge/CARR Powerfuge/Inline High Shear Mixer
  • Terumo/Biowelder/Autoclave

Timeline

Manager, Manufacturing

Abzena
03.2021 - 10.2022

Supervisor Manufacturing-MSAT

Abzena
03.2020 - 03.2021

Sr. Manufacturing Associate

Tanvex
08.2016 - 03.2020

Manufacturing Biologist III

MiliporeSigma
12.2015 - 08.2016

Validation Engineer

ProPharma Group
10.2015 - 12.2015

Senior Production Operator

Pacira Pharmaceuticals
06.2014 - 03.2015

Lead Manufacturing Bioprocess Technician

Genentech Inc. (Roche)
07.2008 - 06.2014

Sr. Manufacturing Bioprocess Technician

Genentech Inc.
04.2005 - 07.2008

Manufacturing Bioprocess Technician

Biogen-Idec
12.2001 - 04.2005

Logistic Specialist

IMED Corp. (Alaris Medical System)
01.1990 - 12.2001

Associate of Arts - Computer Networking And Telecommunications

Kelsey-Jenney Business College

Bachelor of Science - Microbiology

University of The Philippines

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Edwin SalazarOperations Manager