Senior Analytical Specialist, iPSC

Job description

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 Working collaboratively across Manufacturing, Quality Assurance, Quality Control, and external partners, the Senior Analytical Specialist plays a critical role in maintaining assay performance, supporting product release, investigating laboratory deviations, and ensuring adherence to GMP, regulatory, and company quality standards. Perform in-process and release testing of iPSC banks, including flow cytometry, qPCR, STR, endotoxin, and ELISA, independently Author and/or review protocols, summary reports, and SOPs for testing, validation, method transfers, equipment qualifications, equipment operation, and analytical test methods Participate in technology transfer, method qualification, and validation independently Coordinate testing activities with external contract laboratories, including sample shipment, method transfers, data review, and ensuring compliance with company standards and regulatory requirements Support installation/operation/qualification (IQ/OQ/PQ) of new equipment, including drafting/reviewing protocols, executing tests, and coordinating with contract vendors Ensure laboratory equipment is calibrated, maintained, and ready for use. Troubleshoot instrumentation as needed Maintain laboratory inventory and supplies; perform routine housekeeping of the laboratory space Lead and conduct routine investigations for out-of-specification (OOS) results/deviation investigations and CAPA implementation as needed Serve as primary point of contact for routine testing status in manufacturing and project updates Train manufacturing operators on assay sample preparation and basic equipment handling Analyze, organize, and present data results in weekly meetings All other duties as required Minimum Requirements Bachelor’s Degree in biology, molecular biology, immunology, or related field 5+ years of relevant experience in analytical testing with a Bachelor's Degree or 3+ years of relevant experience in analytical testing with a Master's Degree Proficiency in performing lot release assays and cell characterization assays (i.e., flow cytometry, qPCR, STR, endotoxin, ELISA) Ability to independently troubleshoot assays Experience with Good Documentation Practices (GDP) record keeping, preferably in a cGMP environment Strong written and verbal communication skills to interact cross‑functionally and with management; ability to clearly summarize testing status and quality issues Detail‑oriented, organized, and self‑motivated with the ability to prioritize work in a dynamic environment; able to work independently and within a multi‑functional team Excellent interpersonal skills with the ability to communicate effectively and collaborate cross-functionally Preferred Qualifications Master’s Degree in biology, molecular biology, immunology, or related field 2+ years of experience in a GMP pharmaceutical laboratory Knowledge of cGMP requirements and QC laboratory practices Experience with method transfers, assay qualification, and validation Experience performing equipment qualification (IQ/OQ/PQ) Familiarity with OOS/deviation investigation (RCA and CAPA) execution in QC assays Knowledge and understanding of sterility, mycoplasma, and NGS assays Job Location United Therapeutics requires this role to be 100% onsite in our Silver Spring, MD office. The salary range for this position is $92,500 - $122,500 per year and reflects 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. 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.