What are the responsibilities and job description for the IT Business Operations Analyst position at Krystal Biotech, Inc.?
Business Operations Analyst
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.
Job Description Summary
Krystal Biotech, Inc. is seeking a motivated Business Operations Analyst to join our IT team. This role supports the day-to-day operation, maintenance, and continuous improvement of enterprise systems used within GxP CMC business functions, while offering a strong opportunity to build and expand foundational knowledge of platforms such as LIMS, QMS, Veeva Vault, and TrackWise.
This role provides hands-on exposure to IT systems, databases, and application support, along with the ability to develop expertise in SDLC and validation methodologies, including system validation and documentation best practices. Additionally, the position offers exposure to IT infrastructure concepts such as backup and recovery, as well as regulatory frameworks (e.g., GxP, FDA 21 CFR Part 11, and data integrity), with the opportunity to learn and apply compliance requirements in a practical, real-world environment.
Primary Responsibilities
Powered by JazzHR
T6ZAWDz1uV
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.
Job Description Summary
Krystal Biotech, Inc. is seeking a motivated Business Operations Analyst to join our IT team. This role supports the day-to-day operation, maintenance, and continuous improvement of enterprise systems used within GxP CMC business functions, while offering a strong opportunity to build and expand foundational knowledge of platforms such as LIMS, QMS, Veeva Vault, and TrackWise.
This role provides hands-on exposure to IT systems, databases, and application support, along with the ability to develop expertise in SDLC and validation methodologies, including system validation and documentation best practices. Additionally, the position offers exposure to IT infrastructure concepts such as backup and recovery, as well as regulatory frameworks (e.g., GxP, FDA 21 CFR Part 11, and data integrity), with the opportunity to learn and apply compliance requirements in a practical, real-world environment.
Primary Responsibilities
- Provide day-to-day support for the enterprise applications (e.g., LIMS, QMS, EDMS) under the guidance of senior team members
- Assist with user account management, access provisioning, and basic system configuration
- Respond to service requests and troubleshoot basic system issues; escalate complex issues as appropriate
- Support system implementations, upgrades, patching, and validation activities (IQ/OQ/PQ)
- Maintain and update system documentation, including SOPs, user guides, and validation records
- Collaborate with cross-functional teams to understand user needs and support system enhancements
- Assist in ensuring systems adhere to GxP and data integrity requirements
- Support internal and external audits by preparing documentation and responding to requests
- Participate in routine system monitoring, including data backup checks and basic reporting activities
- Coordinate with vendors for issue resolution under supervision
- Perform other duties as assigned
- Bachelor's degree in Computer Science, Information Systems, Life Sciences, or a related field
- 1–3 years of relevant experience (internships or academic projects acceptable)
- Interest in working within a regulated biotech or pharmaceutical environment
- Strong willingness to learn and grow in a technical environment
- Analytical thinking and problem-solving skills
- Effective communication and collaboration across teams
- Customer-focused mindset with strong interpersonal skills
- Strong organizational skills and attention to detail
- Highly motivated self-starter with the ability to take initiative, manage tasks independently, and adapt in a dynamic environment
Powered by JazzHR
T6ZAWDz1uV