Biomanufacturing Associate I - Production Support

Front Door Defense; North Carolina; Hybrid; USD 60,000 - 85,000; Full time

Benefits offered by this job

401k and ESPP

Paid time off and parental leave

Job summary

United Therapeutics Corporation seeks a Biomanufacturing Associate I, Production Support to bolster GMP manufacturing operations at the RTP, NC site. You will aid in material handling, equipment readiness, and data recording to ensure smooth product runs.

The role emphasizes aseptic technique, GDP compliance, and teamwork in a 24/7 environment, offering hands-on experience in a start-up GMP facility focused on tissue engineering and biomanufacturing.

Qualifications

• 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 and strong general computer skills.
• Strong attention to detail and adherence to 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.
• 1+ years of cGMP biomanufacturing, R&D, or laboratory operations experience (preferred).

Responsibilities

• Support activities related to manufacturing operations and material handling to meet departmental objectives.
• Operate bioprocess equipment and perform production support processes in GMP-compliant conditions.
• Monitor and restock supplies; ensure proper inventory rotation and monitor expiration dates.
• Accurately record data in batch records, logbooks, and system documentation per GDP.
• Draft process deviation reports and assist with calibration and maintenance scheduling.

Skills

Aseptic technique

Verbal & written communication

Attention to detail

Team collaboration

24/7 shift flexibility

GDP adherence

Education

Bachelor's degree in biology/biotech/biomedical engineering or related field

Tools

Microsoft Office

Job description

Biomanufacturing Associate I - Production Support

Support manufacturing operations by maintaining materials flow and equipment readiness for GMP runs

Location: RTP, North Carolina

About The Role

Biomanufacturing Associate I, Production Support

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.

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

This position is located 100% onsite at our RTP, NC location.

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.

United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.