Biotech & Pharma STEM OPT Jobs in North Carolina
North Carolina's Research Triangle Park anchors one of the country's most concentrated biotech and pharma clusters, with employers like Biogen, Pfizer, and Novo Nordisk historically filing F-1 STEM OPT Labor Condition Applications for roles in research, manufacturing, and regulatory affairs. Durham, Raleigh, and Morrisville see the highest concentration of STEM OPT-eligible biotech postings in the state.
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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
You’re an experienced systems analyst who understands the unique demands of supporting GxP applications in manufacturing and laboratory environments. You bring hands-on experience with application configuration, validation testing, troubleshooting, upgrades, enhancements, and system implementations. You’re equally comfortable investigating a break/fix issue, contributing to a project initiative, training end users, or coordinating with a software vendor. You’re organized, collaborative, and able to balance technical requirements, business needs, and the documentation and rigor required in a validated environment.
ROLE AND RESPONSIBILITIES
The GxP Systems Analyst, Operational Technology will provide application support for the new and existing manufacturing and laboratory systems. This will include project initiatives such as upgrades, enhancements, and new installations as well as break/fix support in a regulated, validated environment. This position will also include liaising between software vendors and internal departments.
- Participate in project initiatives such as system enhancements, upgrades, and new installations. Configure the software to meet user requirements, execute the validation testing, create/revise SOPs, and train the end users. Collaborate with software vendors and other UT departments to meet project timelines.
- Provide break/fix support for designated systems in accordance with department response time SLAs to include, but not limited to, troubleshooting application errors, database errors, and user login issues as well as performing routine tasks such as creating user accounts, assigning access, and performing system maintenance activities and testing.
- Work with other internal stakeholders to meet 21cfr11 computer regulations and all required data integrity requirements.
- Ensure the continuous, uninterrupted availability and functionality of computer systems, and coordinate appropriate resources to respond to outages and emergencies.
- Participate in internal team initiatives and process improvement efforts.
- All other duties as required.
MINIMUM QUALIFICATIONS
- Associate degree in information technology, chemical engineering, bioengineering or an applicable scientific and/or engineering discipline preferred, and 4+ years of experience supporting GxP systems, or
- Bachelor’s degree in information technology, chemical engineering, bioengineering or an applicable scientific and/or engineering discipline preferred, and 2+ years of experience supporting GxP systems.
- 2+ years of experience in an FDA regulated pharmaceutical manufacturing environment, with emphasis on manufacturing system administration, development and support.
- Prior experience with Level 1 or 2 application support.
- Prior experience working in a computer system support environment utilizing a ticket management system to track and manage support requests.
- Ability to work well in a team environment and collaborate, communicate and prioritize workload.
- Manufacturing or Quality system application support experience.
- Computer hardware/software validation and change control experience.
- Experience collaborating with tools such as Microsoft Teams, Sharepoint and Smartsheets.
- Working knowledge of MS SQL Server and Windows Server.
- Experience in executing projects, system life-cycle process, gathering and documenting requirements, executing protocols, and understanding of methodology for execution.
- Manufacturing or Quality System Application support experience with MasterControl, Blue Mountain RAM, Tracelink Serialization Management System, and Uhlmann line management systems, and/or ERP systems.
- Experience working on small, fast paced project teams.
PREFERRED QUALIFICATIONS
- Certified Project Management Professional (PMP)-PMI.
- System integration experience using tools such as Dell Boomi.
- Experience working with various standalone laboratory instruments such as FTIR, Endotoxin, HPLC, GC, HIAC, Plate Reader, etc.
- Experience completing full project lifecycle software application installations.
- Computer system programming and software development experience.
- Proficiency in SQL or Oracle Database Administration.
LOCATION
United Therapeutics requires this role to be 100% on-site at our Durham, NC office.
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 the company’s careers page.
United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.
INTRODUCTION
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
You’re an experienced systems analyst who understands the unique demands of supporting GxP applications in manufacturing and laboratory environments. You bring hands-on experience with application configuration, validation testing, troubleshooting, upgrades, enhancements, and system implementations. You’re equally comfortable investigating a break/fix issue, contributing to a project initiative, training end users, or coordinating with a software vendor. You’re organized, collaborative, and able to balance technical requirements, business needs, and the documentation and rigor required in a validated environment.
ROLE AND RESPONSIBILITIES
The GxP Systems Analyst, Operational Technology will provide application support for the new and existing manufacturing and laboratory systems. This will include project initiatives such as upgrades, enhancements, and new installations as well as break/fix support in a regulated, validated environment. This position will also include liaising between software vendors and internal departments.
- Participate in project initiatives such as system enhancements, upgrades, and new installations. Configure the software to meet user requirements, execute the validation testing, create/revise SOPs, and train the end users. Collaborate with software vendors and other UT departments to meet project timelines.
- Provide break/fix support for designated systems in accordance with department response time SLAs to include, but not limited to, troubleshooting application errors, database errors, and user login issues as well as performing routine tasks such as creating user accounts, assigning access, and performing system maintenance activities and testing.
- Work with other internal stakeholders to meet 21cfr11 computer regulations and all required data integrity requirements.
- Ensure the continuous, uninterrupted availability and functionality of computer systems, and coordinate appropriate resources to respond to outages and emergencies.
- Participate in internal team initiatives and process improvement efforts.
- All other duties as required.
MINIMUM QUALIFICATIONS
- Associate degree in information technology, chemical engineering, bioengineering or an applicable scientific and/or engineering discipline preferred, and 4+ years of experience supporting GxP systems, or
- Bachelor’s degree in information technology, chemical engineering, bioengineering or an applicable scientific and/or engineering discipline preferred, and 2+ years of experience supporting GxP systems.
- 2+ years of experience in an FDA regulated pharmaceutical manufacturing environment, with emphasis on manufacturing system administration, development and support.
- Prior experience with Level 1 or 2 application support.
- Prior experience working in a computer system support environment utilizing a ticket management system to track and manage support requests.
- Ability to work well in a team environment and collaborate, communicate and prioritize workload.
- Manufacturing or Quality system application support experience.
- Computer hardware/software validation and change control experience.
- Experience collaborating with tools such as Microsoft Teams, Sharepoint and Smartsheets.
- Working knowledge of MS SQL Server and Windows Server.
- Experience in executing projects, system life-cycle process, gathering and documenting requirements, executing protocols, and understanding of methodology for execution.
- Manufacturing or Quality System Application support experience with MasterControl, Blue Mountain RAM, Tracelink Serialization Management System, and Uhlmann line management systems, and/or ERP systems.
- Experience working on small, fast paced project teams.
PREFERRED QUALIFICATIONS
- Certified Project Management Professional (PMP)-PMI.
- System integration experience using tools such as Dell Boomi.
- Experience working with various standalone laboratory instruments such as FTIR, Endotoxin, HPLC, GC, HIAC, Plate Reader, etc.
- Experience completing full project lifecycle software application installations.
- Computer system programming and software development experience.
- Proficiency in SQL or Oracle Database Administration.
LOCATION
United Therapeutics requires this role to be 100% on-site at our Durham, NC office.
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 the company’s careers page.
United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.
STEM OPT Biotech & Pharma Job Roles in North Carolina
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Search Biotech & Pharma Jobs in North CarolinaBiotech & Pharma STEM OPT Sponsorship Jobs in North Carolina: Frequently Asked Questions
Which biotech and pharma companies sponsor F-1 STEM OPT visas in North Carolina?
Companies operating in and around Research Triangle Park have historically filed Labor Condition Applications supporting F-1 STEM OPT workers, including Biogen, Pfizer, Novo Nordisk, Syneos Health, and Labcorp. Smaller contract research organizations and biotechs based in Durham and Morrisville also appear in DOL OFLC disclosure data with STEM OPT-eligible filings. Employer sponsorship patterns shift over time, so confirming active filings before applying is worthwhile.
Which cities in North Carolina have the most biotech and pharma F-1 STEM OPT sponsorship jobs?
The Research Triangle area, covering Durham, Raleigh, and Morrisville, accounts for the large majority of North Carolina's biotech and pharma F-1 STEM OPT postings. Research Triangle Park itself hosts dozens of life sciences employers within a short commute of several major universities. Charlotte has a smaller but growing pharma presence, particularly in manufacturing and quality assurance roles that appear in STEM OPT-eligible job categories.
How do I find biotech and pharma F-1 STEM OPT sponsorship jobs in North Carolina?
Migrate Mate filters biotech and pharma job listings specifically for F-1 STEM OPT visa sponsorship in North Carolina, pulling from employers with verified DOL Labor Condition Application history. You can search by city, role type, and employer to see which companies have actively sponsored STEM OPT workers in the life sciences sector. This saves time compared to screening general job postings for sponsorship eligibility manually.
What types of biotech and pharma roles typically qualify for F-1 STEM OPT sponsorship in North Carolina?
Roles that qualify for STEM OPT must appear on the official STEM-designated degree list published by USCIS and correspond to the graduate's degree field. In North Carolina's biotech and pharma sector, positions in computational biology, biostatistics, regulatory science, quality engineering, process development, and laboratory research commonly align with STEM-eligible degree categories. Employers confirm the degree-role connection when submitting the required I-983 training plan to the student's Designated School Official.
Are there any state-specific considerations for F-1 STEM OPT sponsorship in North Carolina's biotech sector?
North Carolina does not impose additional state-level visa sponsorship requirements beyond federal USCIS and DOL obligations. However, biotech and pharma employers in regulated environments, particularly those handling clinical trials or FDA-regulated manufacturing, may require background checks or E-Verify enrollment as a condition of employment, which aligns with existing STEM OPT employer compliance requirements. North Carolina's large university system also means many employers are familiar with OPT and STEM OPT paperwork processes.