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.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 patients!
Job Description Summary:
Krystal Biotech, Inc is seeking a highly motivated and dynamic Bioprocess Engineer to support our product manufacturing at our Pittsburgh GMP facility. This role is critical to our make a meaningful difference in the lives of underserved patient populations having rare diseases. Quality, safety and on-time delivery is a must to be successful in this role! The ideal candidate will have foundational experience in upstream and/or downstream biologics or gene therapy manufacturing.
Primary Responsibilities:
- Perform/support/monitor the process steps/activities – buffer preparation, upstream, downstream, Aseptic Fill
- Document/record data following standard operating procedures or GMP documents for process steps and/or equipment activities
- Maintain equipment and operate – facilitate/perform qualifications, cleaning, logbooks
- Clean, maintain, and monitor the GMP facility
- Collaborate with Quality assurance, Quality control, Facilities, Materials and others
- Participate in learning and training to be competent in above functions
- Other duties as assigned
Requirements and Preferred Qualifications:
- Bachelor’s degree, preferably in life sciences
- Expertise working in a clean room facility, 1+ years of professional experience demonstrating proper cleanroom behavior/technique
- Cell culturing / Aseptic technique
- Familiarity with large scale bioreactors highly preferred
- Downstream processing experience
- Filtration/Purification
- Highly organized and detail oriented, while also demonstrating the ability to synthesize information and demonstrate strategic thinking
- Highly self-motivated, flexible, proactive, able to follow through in an ambiguous, fast-changing environment, and proven ability to meet deadlines under pressure
- A demonstrated understanding of the drug development process, biopharmaceutical industry and/or related life sciences industry
- Demonstrated ability to prioritize and manage multiple projects simultaneously
- Demonstrated ability to work effectively with many different types of personalities at all levels of the organization
- Excellent interpersonal, collaboration and stakeholder management skills
- Excellent communication skills (written/verbal)
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.
