Biomanufacturing Associate - Production Support

California, US residents click here.

The job details are as follows:

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.

As part of a start-up, new GMP manufacturing facility focused on tissue engineering and biomanufacturing, the Biomanufacturing Associate I, Production Support, will support activities related to manufacturing operations and material handling to support multiple manufacturing teams to meet departmental and company objectives. This role provides valuable hands-on experience in GMP manufacturing operations.

• Operate bioprocess equipment and perform production support 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
• Responsible for daily monitoring and restocking of supplies and materials; ensure proper inventory rotation (first in first out) and monitor supply expiration dates
• Monitor JIT warehouse inventory, submit materials requests to transfer materials from main warehouse to JIT warehouse
• Routinely prepare team supplies (e.g. single use assemblies, media, buffer) in accordance with established SOPs
• Perform autoclave and parts wash runs. Prepare surgical pans, instruments and other supplies for sterilization
• Assist scaffold production with dissection process. Assist recellularization, cell production with other routine tasks as needed
• Schedule preventative maintenance and calibration (escort vendors in and out) according to Blue Mountain Ram system, to ensure all standalone equipment is maintained according to the schedule
• 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 or process deviations
• Draft process deviation reports as required
• Perform other duties as assigned

• Bachelor’s degree in biology, biotechnology, biomedical engineering, or a related scientific discipline
• 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…