Quick Info
Job Type
Full TimeSpecialty Skills
upstream manufacturingdownstream manufacturinggene therapy manufacturingbuffer preparationaseptic fillGMPcell culturingaseptic techniquebioreactorsfiltrationpurification
About the Role
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)