Summary
Overview
Work History
Education
Skills
Relevant Coursework
Timeline
Generic

Amanuel Negasa

Manufacturing Specialist II
Apex,NC

Summary

With a strong foundation in laboratory procedures, process validation, and biotechnology concepts, I excel in overseeing manufacturing operations as a Gene Therapy Specialist II. I lead teams on the production floor, troubleshooting complex challenges involving UNICORN and chromatography systems, while adhering to GMP regulations. I am skilled in purification techniques such as affinity chromatography, UF/DF, and column handling, ensuring data integrity and operational excellence. I also develop standardized batch schedules, train colleagues through well-structured boot camps, and implement continuous improvement measures to enhance efficiency and resolve process issues. My contributions have been widely recognized, including my successful leadership in the Wilson disease clinical trial, a project that earned commendations from both my team and management.

Forward-thinking team leader skilled at operating departments efficiently to meet goals. Successful background matching employees with roles for maximum performance. Proactive and hardworking individual focused on continuous operational improvement.

Operations professional with substantial experience in optimizing processes and driving operational efficiency. Expertise in project management, process improvement, and logistics coordination. Strong focus on team collaboration and achieving measurable results. Known for adaptability and reliability in dynamic environments.

Proactive and goal-oriented professional with excellent time management and problem-solving skills. Known for reliability and adaptability, with swift capacity to learn and apply new skills. Committed to leveraging these qualities to drive team success and contribute to organizational growth.

Overview

8
8
years of professional experience

Work History

Gene Therapy Operations Specialist II

Pfizer
Sanford, North Carolina
04.2020 - Current
  • Experienced in UNICORN and Delta V operating systems regarding alarms, recipe alteration and operation, and as an analyzation tool.
  • Experienced and trained in running clinical batches in a multi-product facility utilizing single use materials while adhering to GMP regulations with extreme attention to data integrity.
  • Adept with purification methods and equipment including Affinity chromatography, UF/DF, AEX chromatography, depth filtration, manual filtration, column packing, unpacking and cleaning and bottling activities including pooling and spiking based on specific calculations.
  • Experienced in continuous improvement activities including 5s practices, SHINE, and FIFO.
  • Experienced in Imex and continuous improvement measures both site wide and with Pfizer global. In this I am responsible for recognizing areas of fatigue in the lab, acknowledging ideas, recording variances and incidents that cause loss of time and funds, tracking the variances and implementing goals with associated timelines to improve the identified issues.
  • Lead in training colleagues new to the purification group by organizing boot camps that cover common processes within the lab.
  • Oversaw day-to-day operations, delegating tasks appropriately to ensure smooth workflow and timely completion of projects.
  • Provided training for new hires, fostering a supportive learning environment conducive to success in their roles.
  • Collaborated across departments to identify opportunities for process improvements and increased efficiency.
  • Successfully managed multiple projects simultaneously while adhering to deadlines and budget constraints.

Associate Scientist

Seqirus pharmaceutical company
Holly Springs, North Carolina
05.2019 - 10.2019
  • With extensive experience in conducting qualification and validation activities, I specialize in identifying and troubleshooting process issues. I ensure proper accountability and traceability of products by executing all necessary documentation and functions. Additionally, I have identified and addressed compliance, environmental, safety, and process deviations, collaborating cross-functionally to determine the best path forward.

Undergraduate Research Assistant

North Carolina Central University
Durham, NC
08.2017 - 05.2018
  • Gained a comprehensive understanding of laboratory procedures and techniques while splitting cells, preparing media, plating cells, and performing preps for cell-based and biochemical assays.
  • Utilized established SOPs while preparing and performing; also utilize aseptic techniques and conduct mammalian cell culture, cell harvesting, and cell lysis.
  • Collected samples and data to record observations, monitored projects for new development and recorded all changes. conducted research projects for new design and test procedures.
  • Adept is analyzing and interpreting data collected from processing, engineering, and validity runs.
  • Demonstrated a mastery of biological technology engineering concepts on routine testing procedures and test subjects.

Education

Bachelor of Science - Pharmaceutical Sciences

North Carolina Central University
Durham, NC
05.2001 -

Skills

  • 1 Advanced Purification Techniques

  • 2 Process Troubleshooting & Validation

  • Proficient in UNICORN and Delta V systems for alarm handling, recipe modification, and data analysis

  • 5 Team Training & Development

  • 6 Biotechnology & Cell Culture Proficiency

  • Demonstrated mastery in mammalian cell culture, cell harvesting, lysis, and biochemical assays

Adaptability and flexibility

Problem-solving abilities

Relevant Coursework

cGMP/FDA Regulations, Bioprocess and cell Culture Lecture and Lab. Laboratory safety, quantitative laboratory, process validation, analytical instrumentation. Immunology and Virology, Molecular Biology, Microbiology, Organic Chemistry, Biochemistry.

Timeline

Gene Therapy Operations Specialist II

Pfizer
04.2020 - Current

Associate Scientist

Seqirus pharmaceutical company
05.2019 - 10.2019

Undergraduate Research Assistant

North Carolina Central University
08.2017 - 05.2018

Bachelor of Science - Pharmaceutical Sciences

North Carolina Central University
05.2001 -
Amanuel NegasaManufacturing Specialist II
Profile made at Zety.com