Quality Control Laboratory Analyst (Raw Materials)

About the Company

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 its science and technology using a patented gene therapy platform, innovative manufacturing supported by 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). The company continues to leverage its proprietary platform to rapidly advance a robust pipeline of investigational genetic medicines in respiratory, oncology, dermatology, and ophthalmology. Krystal is headquartered in Pittsburgh, PA, with state-of-the-art CGMP manufacturing facilities and teams around the world.

About the Role

Krystal Biotech is seeking a highly motivated Quality Control Analyst who will be responsible for in-house raw materials and product testing for use in the manufacture of clinical and commercial drug products.

Responsibilities

• Perform cGMP material inspection for all materials utilized for drug product manufacturing.
• Perform cGMP material testing for all materials needed for further use in the manufacturing process.
• Review analytical data for compliance with regulations, methods, and other specifications or criteria and collaborate with management when data does not meet acceptance criteria.
• Participate in laboratory investigations, quality event investigations, protocol, and report development.
• Initiate and update quality control documentation, such as SOPs, material monographs (specification and testing documents), and test methods.
• Support activities for Document Control and Record Retention.
• Implement USP Quality Standards and verify USP Methods.
• Maintain equipment in the QC Lab by performing and coordinating equipment qualification, calibration, and preventive maintenance.
• Other duties as assigned.

Requirements

• Bachelor’s degree in life sciences or equivalent.
• Experience with pH, Osmo, Endotoxin, Appearance, customized media, cell culture, and FBS testing preferred.
• Demonstrated experience in a laboratory environment and ability to follow SOPs.
• A demonstrated self-starter who is highly motivated and able to address changing priorities.
• Ability to take a proactive approach on the job with the ability to work with a dynamic team.
• Excellent scientific writing, other written, and oral communication skills.
• Proficient in Microsoft Word, Excel, and PowerPoint.