Biomanufacturing Associate I - Production Support

Unither Pharmaceuticals; North Carolina; On-site; USD 52,000 - 76,000; Full time

Benefits offered by this job

Medical/Dental/Vision

401k and ESPP

Paid time off

Paid parental leave

Job summary

United Therapeutics is seeking a Biomanufacturing Associate I, Production Support, for our 100% onsite RTP, NC facility. You will support manufacturing operations and material handling to meet team objectives and provide hands-on GMP manufacturing experience.

The role requires a Bachelor’s degree in a related science, strong GDP practices, aseptic technique, and excellent communication. You will work with cross-functional teams on production schedules and equipment readiness.

Qualifications

• Bachelor’s degree in biology or related scientific field.
• Ability to work independently and in a team.
• Strong computer skills and proficiency with MS Office.
• Excellent verbal and written communication.
• Attention to GDP and documentation practices.

Responsibilities

• Operate and support manufacturing processes in GMP setting.
• Monitor batch records and logbooks, ensuring GDP compliance.
• Assist with equipment maintenance and calibration scheduling.
• Prepare materials and supplies for production runs.
• Support 24/7 operations and on-call shifts.

Skills

Communication skills

Attention to detail

Team collaboration

GDP knowledge

Aseptic technique

Computer skills

Education

Bachelor’s degree in biology/biotechnology/biomedical engineering or related field

Job description

California, US residentsclick 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, 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

Minimum Requirements

• 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 support 24/7 operations and on call as needed
• Proven proficiency in aseptic technique

Preferred Qualifications

• 1+ years of cGMP biomanufacturing, R&D, or laboratory operations experience

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.

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.