Biomanufacturing Associate II - Scaffold Production

California, US residents .

The job details are as follows:

Who We Are

We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs.

United Therapeutics (Nasdaq: UTHR) seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a cure for their daughter’s pulmonary arterial hypertension (PAH). Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF).

The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need. For this reason, we are working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option.

Who You Are

Participate in a variety of activities related to the production of decellularized scaffolds for in vitro and in vivo experiments to meet departmental, company objectives in a start-up GMP manufacturing facility focused on tissue engineering and manufacturing. The role will contribute to the technical transferring of the process from R&D to production-ready. 60% of time is spent on performing daily biomanufacturing operations under strict adherence to cGMP, OSHA and company policies and procedures. 30% of time is focused on maintaining and preparing production documentation, while 10% is dedicated to maintaining personal cGMP training to ensure compliance.

• Operation of bioprocess equipment under strict adherence to cGMP, OSHA and Unither policies and regulations
• Serve as process SME to receive, inspect, and perform surgical preparations and decellularization of primary tissues
• Prepare required assemblies, solutions, tools and samples per production schedule and process orders
• Wash and autoclave supplies as needed
• Perform clean and sanitization of cleanroom environment
• Perform basic cleaning and maintenance of equipment as specified by the Standard Operating Procedure, as needed
• Monitor and audit work processes to ensure compliance and completion of targets
• Receive and handle production of raw materials
• Maintain and prepare production documentation to include good documentation on Master Batch Record, Electronic Batch Record and logbooks
• Analyze and interpret technical data
• Prepare presentations for operational meeting updates
• Scale-up and perform basic trouble-shooting and assist with technical issues
• Review and/or execute related documentation
• Write area SOPs and production batch records
• Work on problems of moderate scope
• Identify, develop and implement process improvements
• Maintain personal cGMP training to ensure compliance
• All other duties as required

Minimum Requirements

• Bachelor’s degree in a directly related Life Science specialty field or the equivalent combination of education and experience
• 1 years of GMP experience
• Demonstrated ability to work effectively in a team
• Microsoft office or equivalent experience; strong computer skills
• Strong documentation practices
• Strong verbal and written communication skills
• Ability to work shifts to cover a 24/7 operation

Preferred Qualifications

• 1 experience in tissue handling and dissection and aseptic technique
• Previously developed and proven proficiency with tissue handling and dissection in addition to aseptic technique

Job Location

This position is located 100% onsite at our RTP, NC location.

At United Therapeutics, our mission and vision are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun, we do good.

#LI-DNI

Eligible employees may participate in the Company’s comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities

United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.