About Krystal Bio:
At Krystal Biotech, Inc., we bring together the brightest and most eager minds to relentlessly pursue the discovery, development and commercialization of gene delivery medicines for patients with serious and life-threatening genetic diseases. Founded in 2016, Krystal is a leader in gene therapy. Krystal received U.S. FDA approval for the first-ever redosable gene therapy treatment, VYJUVEK™, for the treatment of Dystrophic Epidermolysis Bullosa. Krystal continues to leverage our proprietary platform to develop new treatments across a robust clinical pipeline. Located near Krystal’s headquarters are two state-of-the-art GMP facilities.
Krystal Biotech is based in Pittsburgh, PA which is home to our two state-of-the-art GMP facilities. Additional offices are situated in Boston, MA and in Zug, Switzerland.
Join us on our journey to implement our mission to identify, develop and deliver genetic medicines to patents!
Job Description Summary:
Krystal Biotech, Inc is seeking a highly motivated Technical Writer to author high-quality protocols and reports pertaining to process validation, technology transfer, and related activities. The Technical Writer will coordinate cross-functionally with subject matter experts as well as GMP document reviewers and approvers.
- Draft, edit, and review process validation, tech transfer, and regulatory documents.
- Manage timelines and facilitate reviews for key writing deliverables.
- Interact with multi-disciplinary team members and stakeholders to develop documents that meet useability, clarity, and compliance requirements.
- Summarize and interpret development and validation data; present data tables and graphics in a clear, concise, and scientifically accurate manner.
- Manage simultaneous writing projects and prioritize deadlines in a fast-paced environment.
- Identify opportunities for optimization of document preparation processes including automation of data gathering and writing tasks.
- Support Knowledge Management initiatives to enhance data and document storage and retrieval.
Experience and Skills Desired:
- Bachelor’s Degree in Engineering, Life Sciences or related
- 1+ year of professional experience
- Technical writing training or practical experience is highly preferred
- Knowledge of cGMP regulations for pharmaceutical manufacturing will be an asset
- Pharmaceutical validation, process engineering, or similar experience is a plus
- Proficiency with Microsoft Office applications (Word, Excel, Outlook, PowerPoint)
- Experience with statistical analysis software or programming languages such as JMP or Python is a plus
- Must be a self-starter and capable of working with minimal oversight
- Excellent oral and written communication skills
Krystal Biotech, Inc. is an Krystal Biotech, Inc.