3D Bioprocessing Associate I

Role Summary

The 3D 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 Team Members during launches
• Other duties, as assigned

Qualifications

• High School Diploma or GED, required
• Associate or Bachelors 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
• Will spend time in a clean room environment for manufacturing operations and will be required to meet applicable gowning and personal protective equipment guidelines
• Will be required to regularly sit; stand for prolonged periods of time. Also may occasionally be required to pull, lift and/or move up to 20 pounds
• Position may require working holidays, weekends and 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 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

Skills

• Operational excellence in bioprocessing environments
• Documentation and record-keeping compliant with cGMP
• Collaboration and cross-functional teamwork
• Problem identification, root cause analysis, and CAPA implementation

Education

• High School Diploma or GED; higher education preferred

Additional Requirements

• Will spend time in a clean room environment and adhere to gowning/PPE guidelines
• Regularly sit/stand; may lift up to 20 pounds