What are the responsibilities and job description for the Bioprocess Engineer position at Krystal Biotech, Inc.?
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 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:
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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 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
- 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)
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