2D Bioprocessing Associate I

Role Summary

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

Responsibilities

• 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

Qualifications

• 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, proactive attitude; ability to work in a fast-paced, cross-functional team
• Strong organizational and time management skills; ability to set priorities
• Flexible and adaptable; self-motivated critical thinker with strong interpersonal skills
• Represents the organization in a positive and professional manner

Skills

• Communication and interpersonal skills
• Team collaboration
• Documentation and compliance with cGMP
• Clean room gowning and PPE knowledge (preferred)

Education

• High School Diploma or GED required; Associate or Bachelor’s degree preferred