Quality Control Analyst I

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 by our science and technology using a patented gene therapy platform, innovative manufacturing supported by commercial-scale facilities, and a unique commercialization model focused on the patient’s end-to-end experience. Krystal received U.S. FDA approval for VYJUVEK®, the first and only redosable gene therapy for Dystrophic Epidermolysis Bullosa (DEB), and continues to advance a robust pipeline of investigational genetic medicines in respiratory, oncology, dermatology, and ophthalmology. Headquartered in Pittsburgh, PA, with state-of-the-art CGMP manufacturing facilities and global teams, we embody values of care, fearlessness, integrity, and passion for our work.

Responsibilities

• Perform complex analytical testing for the release of drug products for clinical and commercial use, including finished product testing and stability testing.
• Report QC results to management and review analytical data, notifying management if data falls outside prescribed acceptance criteria or specifications.
• Support laboratory investigations, deviation investigations, CAPA, and change requests as required by QC management.
• Initiate and complete clinical laboratory investigations as needed.
• 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 QC lab equipment through adherence to SOPs in collaboration with QC supervisors.
• Participate in QC projects and global audits as required.
• Maintain all QC lab spaces in an audit-ready state.
• Perform other duties as assigned.

Requirements

• Bachelor’s degree in life science required.
• Experience with the following techniques: Mammalian Cell Culture, Plaque Titer, ELISA, qPCR, Southern Blot, and Western Blot.
• Proficiency in Microsoft Word, Excel, and PowerPoint.
• Environmental monitoring experience is a plus but not required.
• Demonstrated ability as a self-starter who is highly motivated and adaptable to changing priorities.
• Proactive approach with the ability to work effectively in a dynamic team environment.
• Excellent scientific writing, written, and oral communication skills.