Quality Control Analyst I

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, 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.

Responsibilities

• Finished product testing, stability testing, and reporting of QC results to management.
• Review analytical data and notify management if data is outside the prescribed acceptance criteria or specification.
• Support laboratory investigations, deviation investigations, CAPA, and change requests as required by QC Management.
• Initiate and complete clinical laboratory investigations as required.
• Participate in the execution of analytical method validation and/or method transfer.
• Support activities for Document Control and Record Retention.
• Facilitate material management through purchasing, receipt, inventory, storage, and sampling.
• Maintain equipment in the QC Lab according to equipment SOPs, working with QC Supervisors.
• Participate in QC projects as needed and as instructed.
• Participate in all global audits as required.
• Maintain all QC Lab spaces in an audit‑ready state.
• Other duties as assigned.

Qualifications

• Bachelor’s degree in a life science.

Skills

• Experience with mammalian cell culture, plaque titer, ELISA, qPCR, Southern blot, and Western blot.
• Proficiency in Microsoft Word, Excel, and PowerPoint.
• Environmental monitoring experience (a plus, not required).
• Self‑starter with high motivation and ability to address changing priorities.
• Proactive approach and ability to work with a dynamic team.
• Excellent scientific writing and oral communication skills.