Piper Companies is seeking a Biomanufacturing Associate to join a cutting-edge, start-up GMP Manufacturing facility in Raleigh, NC. This facility is focused on tissue engineering and manufacturing, and the Biomanufacturing Associate will play a key role in producing decellularized scaffolds for both in vitro and in vivo experiments. This position offers a unique opportunity to contribute to innovative bioprocessing in a dynamic and collaborative environment.

Responsibilities of the Biomanufacturing Associate I Include:

• Operate bioprocess equipment in compliance with cGMP, OSHA, and company policies.
• Receive, inspect, and perform surgical preparations and decellularization of primary tissues.
• Handle production raw materials according to Process Orders and Picklists.
• Prepare assemblies, solutions, tools, and samples per production schedule.
• Wash and autoclave supplies as needed.
• Clean and sanitize cleanroom environments.
• Perform basic cleaning and maintenance of equipment per SOPs.
• Monitor and audit work processes to ensure compliance and target completion.
• Conduct assays or other measures to assess solution and material compliance.
• Document production activities in Master Batch Records, Electronic Batch Records, and logbooks.
• Assist with scaling-up processes, troubleshooting, and resolving technical issues.
• Maintain and prepare production documentation.
• Review and execute related documentation.
• Participate in ongoing personal cGMP training to ensure compliance.
• Perform other duties as assigned.

QUALIFICATIONS OF THE BIOMANUFACTURING ASSOCIATE I INCLUDE:

Minimum Requirements:

• Bachelor’s Degree (BA/BS) in Life Sciences or a related field, or equivalent combination of education and experience.
• GMP experience.
• Ability to work effectively in a team environment.
• Proficiency in Microsoft Office or equivalent software.
• Strong understanding of Good Documentation Practices.
• Excellent verbal and written communication skills.
• Exceptional organizational skills with attention to detail and quality.
• Flexible, adaptable, and proactive approach to tasks.
• Willingness to learn and consistently follow established procedures.

Preferred Qualifications:

• Experience with tissue handling, dissection, and aseptic technique.

#LI-AW1 #LI-ONSITE

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• Operate bioprocess equipment in compliance with cGMP, OSHA, and company policies.
• Receive, inspect, and perform surgical preparations and decellularization of primary tissues.
• Handle production raw materials according to Process Orders and Picklists.
• Prepare assemblies, solutions, tools, and samples per production schedule.
• Wash and autoclave supplies as needed.
• Clean and sanitize cleanroom environments.
• Perform basic cleaning and maintenance of equipment per SOPs.
• Monitor and audit work processes to ensure compliance and target completion.
• Conduct assays or other measures to assess solution and material compliance.
• Document production activities in Master Batch Records, Electronic Batch Records, and logbooks.
• Assist with scaling-up processes, troubleshooting, and resolving technical issues.
• Maintain and prepare production documentation.
• Review and execute related documentation.
• Participate in ongoing personal cGMP training to ensure compliance.
• Perform other duties as assigned