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
- 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)
