Senior Biomanufacturing Associate, 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 Senior Biomanufacturing Associate, 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. You will act as a subject matter expert for production operations, provide technical support, and guide the implementation of best practices while mentoring junior team members. 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
• Serve as SME, or go to operations expert in all production operations, including operation of equipment and process, to support department objectives Often act as a team leader, coordinating and leading the work of others
• 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
• Monitor and audit work processes to ensure compliance and completion of target
• 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
• Gather and analyze information to lead resolution of production problems with minimal guidance
• Lead closure of process deviations, investigations and corrective actions
• Recommend improvements to existing processes and solutions to improve the efficiency of the team. Contribute to the development of methods and procedures on new assignments
• Train junior team members on operations of all equipment and processes. Train the team on newly developed improvements and solutions
• Write area SOPs and production batch records
• Present data and process updates in internal team meetings as needed
• Perform other duties as assigned

Minimum Requirements

• Bachelor’s Degree in biology, biotechnology, biomedical engineering, or a related scientific discipline
• 4+ years of experience working with primary cell culture and expansion, hands on experience with bioreactor systems
• Direct and extensive experience with primary cell culture and expansion
• Proven, hands-on experience with bioreactor systems used in tissue engineering
• Demonstrated expertise in aseptic technique
• Proven ability to lead manufacturing campaigns with minimal supervision
• Strong troubleshooting skills. Experience with process optimization
• 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)
• Strong documentation skills with experience authoring SOPs, MBRs, deviation reports
• Excellent verbal and written communication skills
• Ability to work flexible schedules, including shifts, to support 24/7 operations as needed
• Proven proficiency in tissue handling, and aseptic technique

Preferred Qualifications

• 2+ years of experience a cGMP (current Good Manufacturing Practices) biomanufacturing, cell culture, or tissue engineering environment

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.