Anteneh Haile

Oakland, CA

( 510-***-**** * ac7or5@r.postjobfree.com

https://www.LinkedIn.com/in/anteneh-haile

Laboratory Management Biotechnology Specialist Good Manufacturing Practices

SOP Revision and Development Cell Culture and Aseptic Techniques Accuracy

Accomplished, detail-oriented Cell Culture and Biotechnology Researcher. Highly regarded for more than 12 years of experience developing and executing Quality Control and Assurance procedures to ensure accuracy and efficiency of laboratory operations. Exceptional interpersonal written and verbal communication skills with the ability to examine, understand the specific needs of project goals, budget, and timeline, to exceed all expectations. Out-of-the-box, analytical thinker dedicated to solving complex problems, develop process improvements for lab functions such as cell culture fermentation, aseptic techniques, and batch production records. Accustomed to performing in deadline-driven, fast-paced environments while pushing creative limits.

Core Competencies

Biotechnology and Fermentation

Laboratory Operations

Quality Assurance/Control

Communication

Aseptic Techniques

Research and Analysis

Cell Culture/Media

Batch Production Records

Problem-Solving

Standard Operating Procedures

Process Improvements

Team Management

Professional Experience

BAYER HEALTHCARE BERKELEY, CA 2005 TO PRESENT

Senior Certified Biotech Specialist

Serve as Assistant Supervisor and Trainer in Cell Culture Fermentation to manage shift operations, review documents, provide orientation and ongoing education for production technicians, ensuring process understanding and cohesion. Employ SAP for management and timely release of clinical products, verifying all projects are delivered within strict procedural guidelines and under budget. Expertly operate, maintain, and troubleshoot bench top analytical equipment including pH meters, conductivity meters, Blood Gas Analyser, YSI analyzer, and Cedex Cell Counter. Ensure a consistent, controlled laboratory environment through cleaning, decontaminating, and sterilizing equipment. Perform routine production tasks with exceptional accuracy, including sample fermenters harvest and UFTCF.

Spearhead laboratory operations and conditions to prepare for routine FDA and EMA inspections, maintaining cGMP guidelines.

Analyze existing production SOPs to identify areas for potential optimization, writing and revising as needed to enhance efficiency

Collaborate with 5S implementation team in Cell Culture/Media departments to re-engineer business processes, resulting in improved organization and workflow efficacy on the production floor.

Coordinate with researchers in Senior Certified Program, overseeing execution of fermenter basket air-flow optimization, potency stability and troubleshooting Reactor projects in Cell Culture/Media departments.

Strategically evaluate executed Batch Production Records (BPRs), documenting and distributing findings for peer review

Generate aseptic connections, processing harvest through tactical use of cell separation and ultrafiltration skids.

Perform meticulous fermenter turnaround, including cleaning, preparation, integrity testing, sterilization, set-up and inoculation.

Subject matter expert in troubleshooting and maintenance of cell culture analytical equipment’s.

Handle analytical equipment standardization, sample fermenter reactors, sample TOC, microbial and Endotoxin water samples.

Knowledgeable in blast freezing cTCF materials, monitor and control operations with automated computer control systems.

Work with QA validation and conformance departments to validate and commission new equipment’s and new procedures.

Collaborate with engineering and quality group in decommissioning cell culture equipment’s and production areas during production shutdown.

Education

University of California Davis, Davis, CA: Bachelor of Science – Fermentation and Microbial Biotechnology

Certifications or Additional Education

Health Care GMP Batch Record Review Seminar – Bayer Health Care

GMP Essentials – Bayer Health Care

Project Management – Bayer Health Care

Kaizen Training, Communication, and Leadership – Bayer Health Care

Additional Credentials

Technical Skills

Microsoft Office (Word, Excel, PowerPoint, Outlook, Access, Publisher) / SAP

Honors & Awards

Special recognition from Manufacturing science, safety recognition

Laboratory Skills

Chemical reagents, autoclave equipment, aseptic technique, micropipettes, PH electrodes, Blood Gas analyzer, oxygen and carbon dioxide incubators, fume hoods

Organizations

Bayer Healthcare Diversity group, operational excellence, Bayer soccer team

Volunteerism

Hemophilia walk, participate in Biotech partnership program developing high school interns

Detailed References Available on Request

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