About Krystal Bio: At Krystal Biotech, we bring together the brightest and most eager minds to relentlessly pursue the discovery, development, manufacturing, and commercialization of genetic medicines to treat diseases with high unmet medical needs. Founded in 2016, Krystal is distinguished in three powerful ways: science and technology using our patented gene therapy platform, innovative manufacturing supported by our commercial scale facilities, and a unique commercialization model that focuses on the patient's end-to-end experience. Krystal received U.S. FDA approval for the first and only redosable gene therapy treatment, VYJUVEK®, for the treatment of Dystrophic Epidermolysis Bullosa (DEB). Krystal continues to leverage our proprietary platform to rapidly advance a robust pipeline of investigational genetic medicines in respiratory, oncology, dermatology, and ophthalmology. Krystal is headquartered in Pittsburgh, PA, which is home to our two state-of-the-art CGMP manufacturing facilities with teams around the world and satellite offices in Switzerland, Germany, and Japan. We are a company built and run by people who care, are fearless in the face of a challenge, love the work they do, and practice the highest level of scientific integrity. As we grow, we are seeking team members that embody these values. Job Description Summary: Krystal Biotech, Inc is seeking a highly motivated Research Associate, Analytical Sciences and Clinical Testing Services to perform high quality analytical testing in support of Krystal's process development, product development, and clinical sample analysis efforts. This position will be laboratory based, Monday-Friday standard hours. Specific responsibilities include but are not limited to:Perform routine analytical testing of in-process and drug product samples from the process development groupParticipate in product development studiesPerform clinical sample analysis under regulated methods, adhering to all policies and procedures under the clinical quality management system. Perform assessments of new technology/chemistry to improve Krystal's analytical testing platformMaintain equipment and troubleshoot instrumentation problemsCleaning and general lab maintenanceMaintain regular and punctual attendanceMaintain company quality and safety standardsPerforms other duties as assigned by managerExperience and Skills Desired:Minimum of a Bachelor's degree (Biology, Biochemistry, Chemistry, or related science) with 0-2+ years of relevant experience in a biotech or pharmaceutical setting required, 1-3+ years desired2+ years of experience in aseptic cell culture is requiredExperience with molecular and cell-based assays including ELISA, Real Time qPCR, and Western Blotting is strongly desiredExperience in virology or gene therapy is desired including titer assaysMust be able to work aseptically and wear Personal Protection Equipment (PPE) in the laboratoryBackground knowledge/experience of GMP, GLP, GCP, USP, and/or ICH requirements is a plusAbility to work in a fast-paced changing environment and know how to prioritize activities appropriatelyMust be a self-starter and capable of working with minimal oversightMust be detail oriented and conscientious. Ability to understand and follow written proceduresExcellent oral and written communication skills requiredProficiency in modernized computerized systems using Microsoft Office Krystal Biotech, Inc. is an Equal Employment Opportunity and Affirmative Action Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, or disability status. Headhunters and recruitment agencies may not submit resumes/CVs through this Web site or directly to managers. Krystal Biotech, Inc. does not accept unsolicited headhunter and agency resumes. Krystal Biotech, Inc. will not pay fees to any third-party agency or company that does not have a signed agreement with Krystal Biotech, Inc.
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