What are the responsibilities and job description for the Lead Aerosol Testing Specialist, Medical Device Development position at United Therapeutics?
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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 bio-artificial 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 Lead Aerosol Testing Specialist, Medical Device Development, will serve as a technical and subject matter expert for Aerosol Delivery systems and related testing and regulatory standards, and support aerosol product development activities, quoting/scoping aerosol testing activities, aerosol method development and/or validation activities, researching and implementing new test equipment, technologies, and/or techniques, and staying abreast of all relevant industry and/or technical standards in support of aerosol product testing. This individual should be an innovative, adaptive, and self-motivated person who is enthusiastic about collaborating across functions to support design specifications, create appropriate design control documentation, perform verification and validation testing, and assist with risk management activities.
- Lead the drafting of aerosol product test proposals and cost estimations, ensuring that all deliverables are complete, timely, and meet requirements
- Provide aerosol test knowledge and expertise in support of aerosol product development activities
- Liaise with internal teams (MDO, QE, Regulatory, etc) to ensure project goals are in alignment
- Identify and oversee outside vendors, suppliers, partners, and/or consultants in support of aerosol delivery systems test activities.
- Maintain knowledge of and ensure all activities are compliant with all relevant regulatory standards (e.g., 21 CFR Part 820, ISO 13485)
- Research new and emerging technologies, test methods, and test equipment in support of aerosol delivery systems
- Act as the Subject Matter Expert (SME) for a broad range of aerosol testing laboratory instruments, analytical techniques, and SOPs, ensuring technical excellence in ongoing projects
- Author test protocols, technical reports, SOPs, CAPA reports, and/or other quality documents as necessary. Support technical writing practices of design inputs, design outputs, qualification activities, regulatory requirements, and related pursuits.
- Embody and continuous improvement mindset and identify/implement enhancements to commercial processes and working methods
- All other duties as required.
For this role you will need
Minimum Requirements
- Associates Degree in science or engineering (preferably mechanical, biomedical, electrical, or systems engineering) or Bachelor’s Degree in science or engineering (preferably mechanical, biomedical, electrical, or systems engineering)
- 8 years of general laboratory experience with a Bachelor's degree, including knowledge of industry- and aerosol-product test and measurement equipment or 10 years of general laboratory experience with an Associates degree, including knowledge of industry- and aerosol-product test and measurement equipment
- 5 years of inhalation product testing, including particle size and aerodynamic particle size analysis of pMDIs, DPIs, nasal sprays, nebulizers, and soft mist inhalers
- 6 years of experience executing and/or authoring protocols, methods, reports, SOPs, and IQ/OQ documents experience in a regulated industry
- Working knowledge of Design Controls and/or Product Development Process
- Proficiency with Microsoft applications (Word, Excel, Project, PowerPoint) for documentation, data analysis, and presentation
- Demonstrated knowledge in aerosol products testing and regulatory requirements
- Demonstrated experience operating within a GMP or GLP environment, including knowledge and application of applicable documentation standards
- Working knowledge in statistics, data interpretation/presentation, engineering experiments/ design of experiments (DoE)
- Experience with common aerosol lab test and measurement instrumentation and equipment
- Able to work independently with occasional need for guidance
Preferred Qualifications
- Experience with analytical software such as Minitab, Matlab or MathCAD
- Ability to build test rigs and/or fixtures from assembly bill of materials and/or schematics
Job Location
This position is 100% onsite at our Morrisville, 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.
While United Therapeutics does not require vaccination for Covid-19 at this time, we strongly encourage all employees and visitors to remain up to date on vaccinations and boosters to protect one another from illness. Employees working in customer-facing roles must adhere and comply with customers’ credentialing guidelines, which may require vaccination against Covid -19, the influenza virus, and other illnesses that could be harmful to healthcare staff and patients.
United Therapeutics Corporation is an Equal Opportunity/Affirmative Action Employer - EOE Minorities / Females / Protected Veterans / Individuals with Disabilities
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
While United Therapeutics does not require vaccination for Covid-19 at this time, we strongly encourage all employees and visitors to remain up to date on vaccinations and boosters to protect one another from illness. Employees working in customer-facing roles must adhere and comply with customers’ credentialing guidelines, which may require vaccination against Covid -19, the influenza virus, and other illnesses that could be harmful to healthcare staff and patients.
United Therapeutics Corporation is an Equal Opportunity/Affirmative Action Employer - EOE Minorities / Females / Protected Veterans / Individuals with Disabilities
