Bioprocess Engineer at Krystal Biotech, Inc. in Coraopolis, PA

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Job Description

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  About Krystal Bio:
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 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&trade;, for the treatment of Dystrophic Epidermolysis Bullosa.Krystal continues to leverage our proprietary platform to develop new treatments across a robust clinical pipeline.
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 Krystal Biotech is based in Pittsburgh, PA which is home to our two state-of-the-art GMP facilities. Additionaloffices are situated in Boston, MA and in Zug, Switzerland.
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 Join us on our journey to implement our mission to identify, develop and deliver genetic medicines to patients!
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  Job Description Summary:
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 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.
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  Primary Responsibilities:
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   Perform/support/monitor the process steps/activities &ndash; buffer preparation, upstream, downstream, Aseptic Fill
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   Document/record data following standard operating procedures or GMP documents for process steps and/or equipment activities
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   Maintain equipment and operate &ndash; facilitate/perform qualifications, cleaning, logbooks
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   Clean, maintain, and monitor the GMP facility
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   Collaborate with Quality assurance, Quality control, Facilities, Materials and others
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   Participate in learning and training to be competent in above functions
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   Other duties as assigned
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  Requirements and Preferred Qualifications:
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   Bachelor&rsquo;s degree, preferablyin life sciences
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   Expertise working in a clean room facility,1+ years of professional experience demonstrating proper cleanroom behavior/technique
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   Cell culturing / Aseptic technique
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   Familiarity with large scale bioreactors highly preferred
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   Downstream processing experience
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    Filtration/Purification
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   Highly organized and detail oriented, while also demonstrating the ability to synthesize information and demonstrate strategic thinking
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   Highly self-motivated, flexible, proactive, able to follow through in an ambiguous, fast-changing environment, and provenability to meet deadlines under pressure
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   A demonstrated understanding of the drug development process, biopharmaceutical industry and/or related life sciences industry
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   Demonstrated ability to prioritize and manage multiple projects simultaneously
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   Demonstrated ability to work effectively with many different types of personalities at all levels of the organization
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   Excellent interpersonal, collaboration and stakeholder management skills
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   Excellent communication skills (written/verbal)
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 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.
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AI Powered Job Insights

Exciting opportunity for a Bioprocess Engineer at Krystal Biotech, Inc.! They are seeking a motivated individual to support product manufacturing at their state-of-the-art GMP facility in Pittsburgh, PA. This is a chance to contribute to groundbreaking gene therapy solutions for patients with rare diseases. 

📍 Location: Coraopolis, PA  
💼 Position: Bioprocess Engineer  
⏰ Type: Full-time  
📅 Date Posted: March 18, 2024  

Role Summary:  
- Involved in upstream and/or downstream biologics or gene therapy manufacturing.  
- Responsible for maintaining quality, safety, and on-time delivery in processes.  
- Collaborates with various departments including Quality Assurance and Quality Control.  

What You'll Do:  
- Perform and monitor key process steps like buffer preparation, upstream, and downstream activities.  
- Document and record data as per standard operating procedures and GMP guidelines.  
- Maintain and operate GMP facility equipment, including qualifications and logbooks.  
- Participate in training and skill development for ongoing competencies.  
- Keep the GMP facility clean and maintained.  

What's Needed:  
- Bachelor's degree in life sciences or related field.  
- 1+ years of cleanroom experience and proper aseptic techniques.  
- Experience with cell culturing and familiarity with large-scale bioreactors is preferred.  
- Knowledge of downstream processing techniques like filtration and purification.  
- Strong organizational skills and ability to handle multiple projects under pressure.  
- Excellent communication, interpersonal, and collaboration skills.  

This role is perfect for someone dedicated to making a meaningful impact in the biopharmaceutical industry while working alongside a passionate team.

Top Interview Questions

  • Q: Can you describe your experience with upstream and downstream processing in biologics or gene therapy manufacturing?

    A: I have worked on both upstream and downstream processes in a biomanufacturing setting for over two years. In upstream processing, I was involved in cell culture optimization, where I monitored cell growth and adjusted media compositions to maximize yield. In downstream processing, I have experience in filtration and purification techniques, including ultrafiltration and chromatography, which are crucial for ensuring product purity. My hands-on experience, combined with my academic background in life sciences, equips me to contribute effectively in this role.

  • Q: How do you ensure compliance with GMP (Good Manufacturing Practice) regulations in your work?

    A: To ensure compliance with GMP regulations, I follow stringent documentation practices, meticulously recording every process step according to SOPs. I routinely participate in audits and training sessions to stay updated on regulatory changes. Additionally, I maintain a cleanroom environment by adhering to established protocols, which includes proper gowning procedures and equipment sanitization practices. My proactive approach ensures that all aspects of the manufacturing process meet the high-quality standards required in the biopharmaceutical industry.

  • Q: Describe a challenging situation you faced in a bioprocessing project and how you resolved it.

    A: In one project, we encountered lowered yields during a scale-up of an upstream cell culture process. After analyzing the data, I noticed that the oxygen transfer rate was suboptimal in the larger bioreactor. To address this, I collaborated with the engineering team to optimize the agitation and aeration parameters. We conducted small-scale experiments that identified the right settings, which ultimately increased our yield by 20%, keeping us on schedule for our production goals.

  • Q: What strategies do you use to maintain equipment and ensure operational efficiency in a bioprocessing environment?

    A: I prioritize a proactive maintenance strategy that includes regular checks, calibration, and prompt servicing of equipment. I adhere to equipment logbooks and ensure that any maintenance activities are reported and documented according to GMP guidelines. Additionally, I advocate for continuous training sessions for the team to familiarize them with equipment functionality and troubleshooting techniques. This approach minimizes downtime and enhances overall operational efficiency.

  • Q: How do you approach collaboration with cross-functional teams, such as Quality Assurance and Quality Control, during manufacturing processes?

    A: Collaboration with cross-functional teams is vital for successful manufacturing operations. I establish clear communication channels to discuss process requirements and quality expectations. For instance, I regularly participate in cross-departmental meetings to share insights from production and address any quality concerns quickly. By fostering an environment of mutual respect and open dialogue, I ensure that all teams work towards a common goal of delivering high-quality products on time.

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