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.
Position Overview:
Krystal Biotech, Inc is seeking a highly motivated Quality Control Analyst who will be responsible for in-house raw materials and product testing.
Primary Responsibilities:
- Perform cGMP material inspection, testing and release.
- Writing methods for analytical testing of ancillary materials used in the manufacturing process.
- Review analytical data for compliance with regulations, methods and other specifications or criteria.
- Implementation of USP Quality Standards and verification of USP Methods.
- Experience with pH, Osmo, Endotoxin, Appearance, customized media, cell culture and FBS testing.
- Develop a strong understanding of HPLC and other chemistry testing.
Requirements and Preferred Qualifications:
- Bachelor’s degree in life sciences or equivalent.
- Preferably, 1+ years of cGMP experience required with working knowledge of Quality Systems.
- Demonstrated experience in 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 are required.
Krystal Biotech, Inc. is an 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. 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.
