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2D Bioprocessing Associate I

HUMACYTE GLOBAL INC

Durham, NCOnsitePosted 1 day ago
Full TimeEntry LevelManufacturing & CMCBiotechnology
Original posting ↗

Summary

The Bioprocessing Associate I participates in the hands-on production of Humacyte's regenerative vessels.

Job description

Job Summary

The Bioprocessing Associate I participates in the hands-on production of Humacyte's regenerative vessels.

Essential Functions

Under close supervision of Bioprocessing leadership, performs basic processes and serves as a hands-on resource in Manufacturing Humacyte's regenerative vessels by:

  • Supports the daily activities of vessel production
  • Assists with basic/routine cleaning and preparation of production equipment and cleaning/disinfecting of production rooms
  • Assists with assembly, set-up, and disassembly of production equipment
  • Ensures the proper execution of routine production process steps according to defined SOPs and BPRs
  • Ensures 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 Qualification and Validation activities, as assigned
  • Ensures that process issues are identified and communicated to Bioprocessing leadership and team
  • Assists team effort in the effective and timely completion of root cause investigations and CAPA implementations
  • Assists other Bioprocessing

Requirements

  • High School Diploma or GED required
  • Associate or Bachelor's degree preferred
  • 0-1 years of previous experience in pharmaceutical, biotechnology, and/or sterile production environments preferred
  • 0-1 years of cGMP knowledge and requirements, executing SOPs, and documenting work, preferred
  • Basic mechanical aptitude or knowledge of electrical/mechanical equipment, preferred
  • Previous cell culture experience, highly preferred
  • Prior training in or knowledge of gowning in a clean room setting including proper use of PPE preferred
  • Excellent communication and interpersonal skills
  • Positive roll-up-the-sleeves attitude and optimistic outlook
  • Strong ability to work in a fast-paced team environment with fluctuating priorities and demonstrated ability to collaborate within cross functional teams
  • Excellent organizational and time management skills with ability to set own priorities in a timely manner
  • High degree of flexibility and adaptability
  • Self-motivated and organized critical thinker with solid interpersonal and business communication skills
  • Represents the organization in a positive and highly professional manner

Benefits

  • Stock Options
  • 401(k) Matching
  • Medical, Dental & Vision
  • Long & Short Term Disability
  • Life Insurance
  • 23 Days PTO
  • 10 Holidays + 2 Floating
  • Paid Parental Leave

Company overview

Humacyte Global Inc. (Nasdaq: HUMA) is a pioneering biotechnology company specializing in regenerative medicine and tissue engineering. Founded in 2004 and headquartered in Durham, North Carolina, the company has developed a groundbreaking bioengineering platform that creates universally implantable, acellular tissue engineered vessels (ATEV™). In December 2024, Humacyte achieved a significant milestone when the FDA granted full approval for its first product, Symvess™, an acellular tissue engineered vessel for extremity arterial trauma repair. This represents the first FDA-approved, human-derived biologic vessel for vascular injury treatment. The company's innovative platform transforms human cells into off-the-shelf regenerative tissues designed to be universally implantable and capable of remodeling with the patient's own cells over time. Humacyte's technology is being investigated for multiple clinical applications including arteriovenous access for hemodialysis, peripheral arterial disease, coronary artery bypass grafts, and treatment of type 1 diabetes. With over 215 employees, the company continues to advance its mission of engineering regenerative medicine products to save and improve patient lives through bioengineered human tissues and organs.

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