Biomanufacturing Associate II, Cell 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 and biomanufacturing, as the Biomanufacturing Associate II, Cell Production you will support activities related to the generation and maintenance of all master and working cell banks to meet departmental and company objectives. This role provides valuable hands-on experience in establishing a new GMP manufacturing operation, including the technical transfer of processes from R&D to production readiness.
 

• 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 department objectives
• Serve as SME for routine daily operations, working independently with limited supervision
• Routinely perform primary lung cell culture in both 2D and 3D formats to support the generation and maintenance of all master and working cell banks in accordance with established SOPs
• Routinely perform media formulation in accordance with established SOPs
• Monitor bioreactor systems parameters (e.g., pressure, flow, timing) and biological indicators (e.g., metabolism, nutrient consumption)
• Accurately and promptly record data in batch records, logbooks, and system documentation in accordance with Good Documentation Practices (GDP)
• Perform in-process and end-of-process sampling and testing
• Conduct routine analyses of in-process measurements and cell culture data
• Draft process deviation reports as required
• Perform troubleshooting of equipment issues and process deviations of moderate scope, applying discretion within established operational boundaries and procedures as required
• Present data and process updates in internal team meetings as needed
• Draft or update area SOPs and MBRs as assigned
• Identify, develop and implement process improvements

Minimum Requirements

• Bachelor’s Degree in biology, biotechnology, biomedical engineering, or a related scientific discipline
• 2+ years of cGMP biomanufacturing, cell culture or tissue engineering experience
• Direct experience with primary cell culture and expansion
• Proven, hands-on experience with bioreactor systems used in tissue engineering
• Demonstrated expertise in aseptic technique
• Ability to troubleshoot issues of moderate scope
• 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
• Strong attention to detail and adherence to Good Documentation Practices (GDP)
• Excellent verbal and written communication skills
• Ability to work flexible schedules, including shifts, to support 24/7 operations as needed
• Proven proficiency in cell culture, and aseptic technique

At United Therapeutics, our mission and vision are one. We use our enthusiasm, creativity, and persistence to innovate for the unm