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Senior MSAT Engineer

2 months ago

Durham, North Carolina, United States HUMACYTE GLOBAL INC Full time
Job Overview

Position Title: MSAT Engineer III

Department: MSAT

Company: Humacyte Inc is pioneering a groundbreaking biotechnology platform aimed at creating universally implantable bioengineered human tissues, advanced tissue constructs, and organ systems that enhance patient outcomes and revolutionize medical practices. The organization specializes in the development and manufacturing of acellular tissues for a variety of diseases, injuries, and chronic conditions.

Position Summary:

The MSAT Engineer III will play a crucial role in supporting the GMP manufacturing processes of Humacyte's innovative HAV and associated products, working with minimal supervision. This position requires effective collaboration with teams across Manufacturing, Engineering, Process Development, Quality Assurance, and Quality Control, leveraging strong communication skills, technical knowledge, and the ability to influence others to sustain and enhance manufacturing operations.

Key Responsibilities:

  • Act as a subject matter expert in HAV production systems and methodologies.
  • Lead initiatives to troubleshoot manufacturing processes that deviate from expected performance, providing scientific and engineering expertise to identify and implement corrective measures.
  • Quickly identify technical challenges during bioprocessing and initiate actions to resolve these issues efficiently, while also developing procedures to prevent recurrence.
  • Design and implement continuous improvement strategies to enhance process reliability and equipment performance.
  • Maintain a thorough understanding of industry standards, process science, and departmental protocols through active participation in training and development.
  • Assist in the selection, characterization, and implementation of raw materials and single-use components.
  • Deliver comprehensive training and support to operational staff.
  • Collaborate with Process Development to ensure successful transfer of processes.
  • Develop and execute testing protocols, including vendor site evaluations and FAT/SAT processes.
  • Work alongside the Validation team to formulate and execute validation strategies.

Qualifications:

  • Bachelor's degree in a relevant field is required.
  • A Master's degree or higher in a related discipline is preferred.
  • Experience in chemical engineering, biochemical engineering, biotechnology, bioprocessing, cell technology, biomedical engineering, cell therapy, tissue engineering, regenerative medicine, or process development is essential.
  • 5 to 8 years of relevant experience in the pharmaceutical or biotechnology industry, with a strong emphasis on cGMP practices.
  • Demonstrated proficiency in a Process Engineering role with a solid understanding of cGMP manufacturing processes.
  • Experience leading projects related to bioprocessing deviations, change control, process optimization, technical troubleshooting, and modifications to bioprocessing.
  • Strong technical foundation in cell- and tissue-based products.
  • Extensive experience in cell culture-based bioprocessing activities, particularly with adherent mammalian cells.
  • Solid understanding of feedback control and monitoring of relevant process gases, nutrients, and biological waste in mammalian cell systems.
  • Ability to thrive and lead in a dynamic team environment.

The responsibilities outlined in this job description are intended to provide a general overview of the role. They are not exhaustive and may be subject to change based on organizational needs.