What are the responsibilities and job description for the Product Development Chemist II, Device Development position at United Therapeutics Corporation?
California, US residents click 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 The Product Development Chemist II will perform analytical test methods and techniques, maintain instrumentation, and use laboratory-related software. Responsibilities include developing and optimizing analytical methods to support formulation development and finished product testing according to FDA and ICH guidelines (method transfer, method development, and method validation). This role is also responsible for technical writing (SOPs, test methods, specifications, protocols, and reports) and communicating project status to management. Perform analytical test methods and techniques, maintain instrumentation, and use laboratory-related software Develop and optimize analytical methods to support formulation development and finished product testing according to FDA and ICH guidelines (method transfer, method development, and method validation) Technical writing (reviewing and drafting of SOPs, test methods, specifications, protocols, and reports) Review documents on instrument calibrations, qualifications, and preventative maintenance. Assist in coordinating laboratory instrumentation calibrations and maintenance to ensure the lowest possible down time. Review other Chemists’ documentation and data Ensure current compliance with compendial requirements Minimum Requirements Bachelor’s Degree in chemistry or related scientific field 2 years of experience in performing analytical test methods and techniques, maintaining instrumentation, and using laboratory-related software in a pharmaceutical analytical laboratory with a Bachelor's Degree or 1 years of experience in performing analytical test methods and techniques, maintaining instrumentation, and using laboratory-related software in a pharmaceutical analytical laboratory with a Master's Degree Working knowledge of word processing, spreadsheets and email software Working knowledge of Waters Empower Software Technical writing experience and good oral communication skills Preferred Qualifications Master’s Degree in chemistry or related scientific field Working of Master Control, LabWare LIMS, SAP, TrackWise Job Location This position is 100% onsite at our Morrisville, North Carolina lab. 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. We strive to be an organization that engages the minds, hearts, and most spirited efforts of each of our employees. Our sense of purpose transforms what we do from work into mission, occupation into vocation and achievement into success. We challenge our employees with innovative and revolutionary projects, offer an environment which fosters high-level job performance and provide a highly competitive total rewards package. This is what makes United Therapeutics a stimulating place to work.