Quality Control Laboratory Analyst (Raw Materials)

<span style="font-size:11pt;"><span style="font-family:Calibri, sans-serif;"><b>About Krystal Bio:</b> 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.</span></span><br><br><span style="font-size:11pt;"><span style="font-family:Calibri, sans-serif;">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&#8217;s end-to-end experience.</span></span><br><br><span style="font-size:11pt;"><span style="font-family:Calibri, sans-serif;">Krystal received U.S. FDA approval for the first and only redosable gene therapy treatment, VYJUVEK&#174;, 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.</span></span><br><br><span style="font-size:11pt;"><span style="font-family:Calibri, sans-serif;">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.</span></span><br><br><span style="font-size:11pt;"><span style="font-family:Calibri, sans-serif;"><b><span style="border:none 1pt;background:#FFFFFF;padding:0in;"><span style="color:#000000;">Position Overview:</span></span></b></span></span><br><br><span style="font-size:11pt;"><span style="font-family:Calibri, sans-serif;">Krystal Biotech, Inc is seeking a highly motivated Quality Control Analyst who will be responsible for in-house raw materials and product testing for the use in the manufacture of clinical and commercial drug products.</span></span><br><br><span style="font-size:11pt;"><span style="font-family:Calibri, sans-serif;"><b><span style="border:none 1pt;background:#FFFFFF;padding:0in;"><span style="color:#000000;">Primary Responsibilities:</span></span></b></span></span><ul><li style="margin-left:8px;"><span style="font-size:11pt;"><span style="font-family:Calibri, sans-serif;">Perform cGMP material inspection&#160;<span style="color:#000000;">for all materials utilized for drug product manufacturing.</span></span></span></li><li style="margin-left:8px;"><span style="font-size:11pt;"><span style="font-family:Calibri, sans-serif;"><span style="color:#000000;">Perform cGMP material testing for all materials needed for further use in manufacturing process.</span></span></span></li><li style="margin-left:8px;"><span style="font-size:11pt;"><span style="font-family:Calibri, sans-serif;"><span style="color:#000000;">Review analytical data for compliance with regulations, methods and other specifications or criteria and collaborate with management when&#160;data does not meet acceptance criteria.</span></span></span></li><li style="margin-left:8px;"><span style="font-size:11pt;"><span style="font-family:Calibri, sans-serif;"><span style="color:#000000;">Participate in laboratory investigations, quality event investigations, protocol and report development. </span></span></span></li><li style="margin-left:8px;"><span style="font-size:11pt;"><span style="font-family:Calibri, sans-serif;"><span style="color:#000000;">Initiate and update quality control documentation, such as SOPs, material monographs (specification and testing documents), and test methods.&#160; </span></span></span></li><li style="margin-left:8px;"><span style="font-size:11pt;"><span style="font-family:Calibri, sans-serif;"><span style="color:#000000;">Support activities for Document Control and Record Retention.</span></span></span></li><li style="margin-left:8px;"><span style="font-size:11pt;"><span style="font-family:Calibri, sans-serif;">Implementation of USP Quality Standards and verification of USP Methods.</span></span></li><li style="margin-left:8px;"><span style="font-size:11pt;"><span style="font-family:Calibri, sans-serif;"><span style="color:#000000;">Maintain equipment in the QC Lab by performing and coordinating equipment qualification, calibration, and preventive maintenance.</span></span></span></li><li style="margin-left:8px;"><span style="font-size:11pt;"><span style="font-family:Calibri, sans-serif;">Other duties as assigned.</span></span></li></ul><span style="font-size:11pt;"><span style="font-family:Calibri, sans-serif;"><b><span style="border:none 1pt;background:#FFFFFF;padding:0in;"><span style="color:#000000;">Requirements and Preferred Qualifications:</span></span></b></span></span><ul><li style="margin-left:8px;"><span style="font-size:11pt;"><span style="font-family:Calibri, sans-serif;">Bachelor&#8217;s degree in life sciences or equivalent. </span></span></li><li style="margin-left:8px;"><span style="font-size:11pt;"><span style="background:#FFFFFF;"><span style="font-family:Calibri, sans-serif;"><span style="color:#000000;">Experience with pH, Osmo, Endotoxin, Appearance, customized media, cell culture, and FBS testing, preferred.</span></span></span></span></li><li style="margin-left:8px;"><span style="font-size:11pt;"><span style="font-family:Calibri, sans-serif;">Demonstrated experience in laboratory environment and ability to follow SOPs.&#160; </span></span></li><li style="margin-left:8px;"><span style="font-size:11pt;"><span style="font-family:Calibri, sans-serif;">A demonstrated self-starter who is highly motivated and able to address changing priorities.</span></span></li><li style="margin-left:8px;"><span style="font-size:11pt;"><span style="font-family:Calibri, sans-serif;">Ability to take a proactive approach on the job with the ability to work with a dynamic team.</span></span></li><li style="margin-left:8px;"><span style="font-size:11pt;"><span style="font-family:Calibri, sans-serif;">Excellent scientific writing, other written and oral communication skills are required<span style="background:#FFFFFF;"><span style="color:#2b333a;">.</span></span></span></span></li><li style="margin-left:8px;"><span style="font-size:11pt;"><span style="font-family:Calibri, sans-serif;"><span style="background:#FFFFFF;"><span style="color:#2b333a;">Proficient in Microsoft Word, Excel and PowerPoint.&#160;</span></span></span></span></li></ul><br><span style="font-size:11pt;"><span style="font-family:Calibri, sans-serif;"><span style="background:#FFFFFF;"><span style="color:#000000;">Krystal Biotech, Inc. is an <span style="border:none 1pt;padding:0in;">Equal Employment Opportunity and Affirmative Action Employers. 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. </span>Krystal Biotech, Inc. <span style="border:none 1pt;padding:0in;">does not accept unsolicited headhunter and agency resumes. Krystal Biotech, Inc.&#160; will not pay fees to any third-party agency or company that does not have a signed agreement with Krystal Biotech, Inc.&#160;</span></span></span></span></span>