About Krystal Bio:

At Krystal Biotech, Inc., we bring together the brightest and most eager minds to relentlessly pursue the discovery, development and delivery of transformative medicines for people with serious and life-threatening genetic diseases. Founded in 2016, the Company is the leader in redosable gene therapy with prominent clinical and pre-clinical stage programs for dystrophic epidermolysis bullosa, TGM1-deficient ARCI, Netherton Syndrome, Cystic Fibrosis, alpha-1 antitrypsin deficiency, and is advancing research to apply our technology to these and other diseases. The Company’s innovation is fueled by visionary leadership within an entrepreneurial organizational structure with a robust pipeline of investigational medicine.

Our US headquarters is in Pittsburgh, PA with other offices located in Boston, MA and in Zug, Switzerland. For more information about the Company’s platform, commitment to patients and pipeline, please visit http://www.krystalbio.comand engage with us on Twitter and LinkedIn.

We have an exciting journey ahead and a tremendous opportunity for growth, and now is the time to make a meaningful impact on the lives of our patients!

Job Description Summary:

Krystal Biotech, Inc. is seeking a highly motivated Quality Assurance Associate Intern to support the implementation of our quality system, GMP manufacturing area, and Quality Control laboratory.

Top applicants will be entering their final semesters in a relevant field of study such as Biology, Life Sciences or Engineering. The Intern will be available for part time (20-25) hours throughout the upcoming Spring semester.

Primary Responsibilities

• Work with internal teams to obtain an understanding of products and documentation requirements
• Develop foundational knowledge for best documentation practices along with all applicable guidelines and standards
• Update and maintain GMP manufacturing associated documentation
• Support daily QA functions, which include review and approval of manufacturing records and quality control documents
• Provide support for updates on standard operating procedures and associated forms.
• Assist with QA efforts for site cGXP documentation related to the operation of gene therapy manufacturing
• Ensure compliance with regulatory agencies and oversee continuous improvement of company's QA and compliance functions

Requirements & Desired Competencies:

• Currently enrolled and in final year of bachelor’s degree program (preferably in Biology, Life Sciences or Engineering)
• Experience demonstrating a high degree of organization and documentation skills (through academic projects, internship or working experience)
• Background that includes knowledge/experience within regulated environments such as GMP, GLP, and GCP, a plus
• Eager to learn and develop new skills in a dynamic, fast-paced environment
• Excellent communication, both written and verbal

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.