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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
The MS&T Specialist II/Sr. Specialist is responsible for supporting manufacturing in a commercial operations environment. This position is responsible for assisting in the investigation and resolution of manufacturing deviations, non-conformances, and out-of-specification results, supporting the execution of manufacturing change controls, assisting in process development and optimization studies, troubleshooting manufacturing issues, and ensuring the smooth transfer of new products and processes into commercial production. The Specialist II/Sr. Specialist will work closely with manufacturing, quality, engineering, regulatory, and validation teams to ensure robust, efficient, and compliant pharmaceutical operations.
- Assist in the investigation and resolution of manufacturing deviations, non-conformances, and out-of-specification results
- Support root cause analysis efforts for process-related issues, providing data and technical insights
- Support in the execution of manufacturing change controls
- Perform process monitoring & data analysis to monitor process performance, identify trends, and support continued process verification
- Participate in process improvement initiatives to enhance yield and efficiency
- Partner cross-functionally with Engineering, Manufacturing, Quality, Automation, Validation, and Regulatory teams on manufacturing process and equipment projects
- Aid in the technology transfer of new pharmaceutical processes/products to manufacturing
- Contribute to the preparation of process documentation, including batch records, SOPs, and technical reports
- Contribute technical expertise for regulatory filings and assist during internal and external audits
Minimum Requirements
Manufacturing Science & Technology Specialist II
- Bachelor’s Degree in biology, chemistry, biochemistry, or closely related field
- 2+ years of experience in biopharmaceutical industry, with a knowledge of cGMP regulations
- Familiarity with investigational tools such as Fishbone diagrams, 5 Why’s, and Failure Mode and Effects Analysis to solve manufacturing deviations
- Ability in experiment planning, design, execution, optimization, data analysis, interpretation, and communication
- Basic knowledge of GXP guidelines for the biotech industry
- Proficient technical writing skills for preparation of summary reports
- Good organizational skills
- Ability to interpret data critically
- Familiar with Microsoft Office and other common software tools
Preferred Qualifications
- Master’s Degree in biology, chemistry, biochemistry, or closely related field
- 5+ years of experience in biopharmaceutical industry, with a knowledge of cGMP regulations
- Experience with design of experiment studies and software for process optimization
- Familiarity with Fill Finish processes
- Familiarity with Cell Culture and Purification processes
- Ability to perform statistical evaluation of data
- Hands-on experience with specific equipment categories such as bioreactors, purification skids, and fill-finish lines
- Ability to perform basic maintenance of equipment
- Experience with scale-up small scale cell culture and transfer to a cGMP facility for full scale manufacturing
- Understanding of validation lifecycle principles and regulatory guidance
- Familiarity with Benchling or other electronic laboratory notebook software
Minimum Requirements
Sr. Manufacturing Science & Technology Specialist
- Bachelor’s Degree in biology, chemistry, biochemistry, or closely related field
- 5+ years of experience in biopharmaceutical industry, with a knowledge of cGMP regulations
- Mastery of investigational tools such as Fishbone diagrams, 5 Why’s, and Failure Mode and Effects Analysis to solve manufacturing deviations.
- Ability to work independently in experiment planning, design, execution, optimization, data analysis, interpretation, and communication
- Knowledge of GXP guidelines for the biotech industry
- Proficient technical writing skills for preparation of summary reports
- Good organizational skills
- Ability to interpret data critically
- Familiar with Microsoft Office and other common software tools
- Ability to perform basic maintenance of equipment
Preferred Qualifications
- Master’s Degree in biology, chemistry, biochemistry, or closely related field
- Experience with design of experiment studies and software for process optimization
- Practical skills in reading process/equipment P&IDs (Piping and Instrumentation Diagrams) and working with manufacturing automation systems
- Familiarity with Fill Finish processes
- Familiarity with Cell Culture and Purification processes
- Ability to perform statistical evaluation of data
- Hands-on experience with specific equipment categories such as bioreactors, purification skids, and fill-finish lines
- Experience with scale-up small scale cell culture and transfer to a cGMP facility for full scale manufacturing
- Understanding of validation lifecycle principles and regulatory guidance
- Familiarity with Benchling or other electronic laboratory notebook software
Job Location
This role is based 100% onsite at our Silver Spring, MD location.
The salary range for the Manufacturing Science & Technology Specialist II position is $77,000 - $102,000 per year, and the salary range for the Senior Manufacturing Science & Technology Specialist position is $92,500 - $125,000.
These ranges reflect our good-faith estimate of the compensation for this role at the time of posting. An employee’s position within the salary range will be based on factors such as education, qualifications, experience, skills, geographic location, and business needs, as well as other factors permitted by law at the time of posting. This range may be modified in the future based on company and market factors.
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.
Skills Required
- Bachelor's Degree in biology, chemistry, biochemistry, or closely related field
- 2+ years of experience in biopharmaceutical industry, with a knowledge of cGMP regulations
- 5+ years of experience in biopharmaceutical industry, with a knowledge of cGMP regulations
- Familiarity with investigational tools such as Fishbone diagrams, 5 Why's, and Failure Mode and Effects Analysis
- Mastery of investigational tools such as Fishbone diagrams, 5 Why's, and Failure Mode and Effects Analysis
- Ability in experiment planning, design, execution, optimization, data analysis, interpretation, and communication
- Ability to work independently in experiment planning, design, execution, optimization, data analysis, interpretation, and communication
- Basic knowledge of GXP guidelines for the biotech industry
- Knowledge of GXP guidelines for the biotech industry
- Proficient technical writing skills for preparation of summary reports
- Good organizational skills
- Ability to interpret data critically
- Familiar with Microsoft Office and other common software tools
- Ability to perform basic maintenance of equipment
- Master's Degree in biology, chemistry, biochemistry, or closely related field
- Experience with design of experiment studies and software for process optimization
- Familiarity with Fill Finish processes
- Familiarity with Cell Culture and Purification processes
- Ability to perform statistical evaluation of data
- Hands-on experience with specific equipment categories such as bioreactors, purification skids, and fill-finish lines
- Experience with scale-up small scale cell culture and transfer to a cGMP facility for full scale manufacturing
- Understanding of validation lifecycle principles and regulatory guidance
- Familiarity with Benchling or other electronic laboratory notebook software
- Practical skills in reading process/equipment P&IDs and working with manufacturing automation systems
United Therapeutics Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about United Therapeutics and has not been reviewed or approved by United Therapeutics.
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Healthcare Strength — Coverage breadth is positioned as comprehensive with the employer paying most medical, dental, and vision premiums, alongside telehealth, EAP, FSAs, and wellness initiatives. Fertility support is emphasized through full IVF coverage.
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Parental & Family Support — Paid parental leave for all parents with additional time for birthing parents, plus adoption and surrogacy assistance, lactation rooms, and milk‑shipping indicate robust family support. Subsidized onsite childcare is available at key campuses and broader family solutions are offered through a national provider.
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Strong & Reliable Incentives — Annual cash bonus opportunities are a consistent part of total rewards, complemented by equity eligibility and an employee stock purchase plan. Feedback suggests these incentives are widely available across many roles.
United Therapeutics Insights
What We Do
United Therapeutics Corporation is a biotechnology company focused on the development and commercialization of unique products to address the unmet medical needs of patients with chronic and life-threatening conditions. We currently have five approved products on the market, and a long-term mission of providing an unlimited supply of transplantable organs for those who need them! Our employees can be found collaborating across the United States, Europe and Asia. As a group, we are relentless in our pursuit of “medicines for life” and continue to research and develop treatments for cardiovascular and pulmonary diseases, pediatric cancers, and other orphan diseases. #WeAreUnitherians
