Manufacturing Technical Operations III

  • Humacyte Global, Inc.
  • Durham, NC, USA
  • Apr 24, 2024
Full time Manufacturing Technician

Job Description

The Manufacturing Technical Operations III provides basic to advanced technical support for the manufacturing process and is a key liaison between the manufacturing and Humacyte MSAT teams. 

Remote Work Designation: Onsite/Not Remote

  Major Accountabilities:

Performs moderate to advanced scope processes and serves as a hands-on resource in Manufacturing Humacyte’s regenerative vessels by:

  • Provides daily technical floor support for clinical or commercial manufacturing operations.
  • Utilizes advanced process knowledge to identify and provide primary response to manufacturing events and ensures troubleshooting support for challenges identified.
  • Interfaces and acts as liaison between Manufacturing Operations and Manufacturing Science and Technology teams.
  • Performs deviation management support, including initiation, impact assessment, and investigation ownership as needed.
  • Performs daily activities required of vessel production as needed to support peaks in production volume. 
  • Leads change control or small to mid-scale projects.
  • Provides compliance review and/or approval for relevant GMP documents, deviations, CAPAs, change controls, SOPs as needed.
  • Recognizes and solves typical and atypical problems that occur in own work area without supervisory approval.
  • Supports projects of moderate to large scope (e.g. operational excellence, safety). 
  • Supports the collection and tracking of area metrics and process control data.
  • Ensures process steps are executed according to defined SOPs and BPRs and partners with team members to ensure understanding and accuracy.
  • Ensures thorough and proper documentation of activities in accordance with cGMPs. 
  • Adheres to the proper handling of chemically hazardous goods.
  • Interfaces with process automation and electronic business systems. 
  • Supports, and may lead, the revisions of SOPs and BPRs.
  • Supports, and may lead, qualifications and validation activities, as assigned.
  • In collaboration with Bioprocessing leadership, recognizes, troubleshoots, and initiates deviations for process issues of moderate scope.
  • Supports team effort in the effective and timely completion of root cause investigations and CAPA implementation.
  • Provides continuous training of other team members on standard roles as needed.
  • Ensures Humacyte or other required trainings/certifications are up to date.
  • Other duties, as assigned.


Special Skills:

  • Works within clearly defined standard operating procedures (SOPs) and/or scientific methods.
  • Uses advanced knowledge of cGMP manufacturing, Humacyte’s manufacturing process, analytical skills, and application of scientific methods or operational processes to perform a variety of activities.
  • Provides recommended solutions and steps for resolution to problems of moderate complexity to leadership.
  • Identifies areas or situations with greater complexity and partners with the Humacyte MSAT team to ensure appropriate resolution.
  • Possesses deep and strong technical skills and the ability to translate those technical skills into problem solving and solutions.
  • Has ability to differentiate between important and less important tasks within own work and act accordingly.
  • Strong, proactive communicator that is able to interface effectively across multiple departments with support as needed.



  • Requires a Bachelor’s Degree, or equivalent on the job experience.   Master’s degree or above preferred.
  • 5+ years of previous experience in pharmaceutical, biotechnology, and/or sterile production environments, required.
  • Strong knowledge of cGMP requirements, required.
  • Experience executing SOPs and demonstrated thorough and strong documenting work, required.
  • Moderate to advanced mechanical aptitude or knowledge of electrical / mechanical equipment, preferred.
  • Previous cell culture experience, highly preferred.
  • Will spend time in a clean room environment for manufacturing operations and will be required to meet applicable gowning and personal protective equipment guidelines.


 General Competencies:

  • Able to communicate effectively in English, both verbally and in writing
  • Excellent communication and interpersonal skills
  • Possess a positive roll-up-the-sleeves attitude and optimistic outlook
  • Strong ability to work in a fast-paced team environment with fluctuating priorities, and collaborate effectively with others
  • Excellent organizational and time management skills with ability to set own priorities in a timely manner
  • High degree of flexibility and adaptability
  • Basic computer skills required, such as knowledge of MS Word, Excel, PowerPoint, and Outlook
  • Must be able to work as needed to meet tight deadlines and at peak periods
  • Self-motivated and organized critical thinker with solid interpersonal and business communication skills
  • Demonstrated ability to work in a cross-functional team environment
  • Adheres to company and facility specific policies and procedures, including SOP, training and meeting requirements
  • Ensures Humacyte or other required trainings/certifications are up to date
  • Represents the organization in a positive and professional manner

Reports to work on time and as scheduled