Biomanufacturing Associate I, Scaffold Production

California, US residents click here.

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

As part of a start-up new GMP Manufacturing facility focused on tissue engineering/manufacturing, the Biomanufacturing Associate I, Scaffold Production will 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. 60% of time is focused 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. 10% of time is dedicated to personal cGMP training to ensure compliance.
 

• Operate bioprocess equipment and perform production processes in strict compliance with cGMP, OSHA and United Therapeutics (Unither) policies and regulations
• Work as an integral member of the team to support departmental objectives
• Receive, inspect, and perform surgical preparations and decellularization of primary tissues
• Receive and handle production raw materials per Process Orders and Picklists
• 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
• Prepare and perform assays or other measures to assess compliance of solutions and materials
• Accurately and promptly record data in batch records, logbooks, and system documentation in accordance with Good Documentation Practices (GDP)
• Perform basic troubleshooting of equipment issues and process deviations
• Draft process deviation reports as required
• Maintain and prepare production documentation
• Review and/or execute related documentation
• Maintain personal cGMP training to ensure compliance
• Present data and process updates in internal team meetings as needed
• Perform other duties as assigned

Minimum Requirements

• Bachelor’s Degree in a directly related Life Sciences specialty field
• Demonstrated ability to work effectively both independently and as part of a team in a collaborative environment
• Proficiency with Microsoft Office applications (or equivalent software) and strong general computer skills
• Good Documentation Practices
• Excellent verbal and written skills
• Proven organizational skills with great attention to detail and quality of work
• Demonstrate a flexible, adaptable, and a pro-active approach to tasks
• Ability and willingness to learn and follow established procedures in a consistent manner
• Ability to work flexible schedules, including shifts, to support 24/7 operations as needed

Preferred Qualifications

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

Job Location

This is fully onsite role in 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.

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.