Scientist, Analytical Development

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.com and 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 Scientist to perform analytical method development to support research for gene therapy products.

Primary Responsibilities:

• Perform development for analytical methods necessary to support in-process and release testing of drug substance, drug intermediates, and drug product, in addition to raw materials necessary for manufacturing
• Support all areas of the analytical development process, including discovery, design, development, qualification, validation, transfer, and lifecycle management
• Apply systematic, statistically driven thinking to the development of scientifically sound, well understood, and robust analytical methods. Examine scientific literature for new methods to quantitate and characterize viral vectors and process related impurities
• Independently plan and execute experiments, including experimental design, laboratory work, data analysis, interpretation of results, formulation of recommendations, and preparation of deliverables
• Write development/technical reports documenting assay development activities
• Coordinate internal and external analytical method transfer activities
• Other duties as assigned

Requirements & Desired Competencies:

• B.S. in life sciences with 8+ years of relevant experience, M.S. with 6+ years, or PhD with relevant research background
• Advanced degrees and relevant experience with gene therapy are preferred
• Strong experience across a variety of analytical techniques, including ELISA, RT-qPCR, viral titer analysis, cell-based bioassays, Western Blotting, Southern Blotting, and fluorescent imaging
• Background that includes knowledge/experience of GMP, GLP, GCP, USP, and/or ICH requirements for analytical method validation
• Strong oral communication skills, technical writing skills and experience authoring development reports, SOPs, regulatory filings, or other documents preferred
• Understanding of FDA, EMA and other regulatory agency guidance associated with release and characterization assays
• Ability to work in a fast-paced changing environment in conjunction with cross-functional teams.
• Must be a self-starter and capable of working with minimal oversight while handling multiple projects simultaneously
• Demonstrated proficiency with relevant computer software and systems

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.